Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

The Senior Director, Regulatory Affairs CMC, reporting to the Chief Regulatory officer, is responsible for leading the development and execution of global CMC regulatory strategies and content plans across the Tango portfolio, ensuring alignment with scientific principles and risk-based approaches. This role drives the planning, preparation, and delivery of high-quality CMC regulatory submissions, partners cross-functionally with technical and program teams, and provides strategic guidance to support efficient development and successful regulatory outcomes across all stages of the product lifecycle.

Key responsibilities include:

• Develop and execute global CMC regulatory strategy for all Tango products. Refine regulatory strategy as new data become available and re-assess as necessary. Assess regulatory risks and develop mitigations plan, when applicable.
• Develop and get buy-in on regulatory CMC strategy for Health Authority (HA) responses as needed.
• Ensure the CMC development strategy meets global regulatory requirements for registration and over the lifecycle of the product.
• Drive and be accountable for the preparation of dossiers for submission to Health Authorities (NDA/MAA/IND/CTA and post approval changes). Work with the CMC team to develop CMC content and submission plans. Develop strategy for providing responses to HA questions (ensure alignment with CMC functions and global strategy).
• Provide accurate regulatory assessments of chemistry, manufacturing and controls changes to teams/projects and execute regulatory planning and implementation.
• Effectively and tactfully communicate with HA; maintain good rapport and credibility with HA.
• In collaboration with Regulatory Leader, as applicable, determine timing and strategy for HA meetings, prepare company staff for interactions, lead CMC meetings with Health Authorities. Ability to negotiate with HA personnel.
• Provide CMC Regulatory support to health authority inspections.

   

What You Bring:

• Advanced degree with 12+ years of experience developing small molecule, CMC regulatory strategies, with deep expertise in product development and its application to global regulatory strategy; recognized as a subject matter expert in CMC development
• Experience leading interactions with Health Authorities
• Experienced leader with a demonstrated track record of driving results and achieving success
• Strong knowledge of global HA laws, regulations, guidance, and global regulation submission pertaining to small molecule CMC development and registration topics
• Strong understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry
• Experience in communicating cross-functionally. Presents and defends CMC regulatory strategy and opinion to project teams; recognizes global regulatory impact
• Hands on experience in submitting multiple NDAs / MAAs for a new chemical entity and managing the registration process and life cycle management
• Highly organized, detail-oriented, and solution-focused, with the ability to manage multiple priorities and drive execution to completion

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Hybrid

About the Role >>> Submission Content Manager, Regulatory Operations 

The Submission Content Manager plays a critical role within Regulatory Operations by preparing regulatory submission documents for final publishing and delivery to global health authorities. This position ensures that all documents meet technical, formatting, and eCTD (Electronic Common Technical Document) requirements prior to formal submission. The role partners closely with Regulatory Affairs, Medical Writing, CMC, Nonclinical, and Clinical teams to ensure high-quality, compliant, and timely regulatory submissions (e.g., INDs, NDAs, MAAs, amendments). 

The ideal candidate has strong attention to detail, experience with document management and eCTD standards, and the ability to manage multiple concurrent submission activities in a fast-paced environment. 

This role is based out of either our Cambridge, Ma or San Francisco, Ca office and may require up to 15% travel. 

Your work will primarily encompass: 

Document Preparation & Formatting 

• Prepare and format submission-ready documents, including applying PDF standards, bookmarks, hyperlinks, headers/footers, and accessibility elements
• Ensure all documents meet technical standards (e.g., PDF/A compliance, OCR/searchability, file size limits)
• Verify that tracked changes, comments, draft watermarks, and metadata are removed before pre-publishing
• Serve as a subject-matter expert for the Starting Point templates and provide training, guidance, and support to cross-functional teams on how to use these templates effectively

 Submission Assembly Support 

• Assist Regulatory Operations staff in assembling and preparing eCTD sequences for publishing
• Coordinate with submission teams to confirm final document versions and readiness for publishing
• Track and document issues, risks, and deviations, escalating as appropriate
• Work closely with Regulatory Affairs, Medical Writing, CMC, Quality, and Clinical teams to ensure submission accuracy and completeness

Quality Control & Compliance 

• Perform technical QC checks on documents prior to publishing, ensuring formatting, structure, and completeness
• Develop publishing standards and guidelines in coordination with Regulatory Operations and Medical Writing 
• Ensure all pre-publishing activities comply with company SOPs, regulatory guidelines, and eCTD specifications

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s degree is required 
• Knowledge and experience of eCTD submissions 
• Knowledge and experience with enterprise document management systems, preferably Veeva RIM 
• Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking 
• Experience with StartingPoint eCTD templates or equivalent 

 Experience: 

• Minimum 3+ years pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations or Medical Writing
• Demonstrated leadership skills while working in a fast paced and changing environment
• Experience in building and submission of NDA and life-cycle management is highly desirable

Attributes: 

• Displays strong proactive acumen and inclusive way of engagement to drive decision making, turnaround time improvement and effective ways of working 
• Influences the cross-functional team to adapt fit-for purpose solutions to meet the expected timelines 
• Ability to understand, analyze and develop recommendations from multiple complex sources such as scientific and operational perspectives  
• Excellent written and verbal communication skills 
• Excellent negotiation and organizational skills 

The base pay range for this position is expected to be $145,000 - $155,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

Real Chemistry is looking for an Account Director to join our growing Medical Communications team! We are open to Account Director, Senior Account Director, and Group Account Director level candidates!

The Account Director for the Scientific and Medical Affairs team serves as the primary client contact, leading client relationships of ~$2M, providing strategic counsel, and overseeing the successful execution of projects for emerging and mid-stage biotech companies as part of our Biotech Center of Excellence (COE). You will ensure high-quality deliverables, proactively identify opportunities for account growth, and manage internal teams effectively. 

This is a hybrid role based in our Boston office. 

What You’ll Do: 

• Serve as the day-to-day client lead and trusted advisor for emerging and mid-stage biotech partners across medical affairs and publication workstreams, leveraging our Biotech COE
• Provide senior-level strategic counsel on key programs, tailoring recommendations to the realities of emerging and mid-stage biotech (e.g., evolving evidence, rapid timelines, and lean teams).
• Oversee account operations to ensure seamless execution of high-quality deliverables - driving proactive issue resolution, clear stakeholder communication, and consistent delivery standards across the Biotech COE
• Drive strategic planning and account growth by identifying opportunities to evolve and expand programs for existing and identified emerging and mid-stage biotech clients. 
• Ensure financial stewardship across the account, including budget oversight, forecasting, resourcing, and profitability management.
• Mentor and develop team members, fostering a collaborative, high-performing environment and contributing to capability-building within the Biotech COE.
• Stay current on industry trends, competitor activity, and relevant regulatory updates - translating insights into practical guidance for biotech clients.
• Support new business efforts for emerging and mid-stage biotech, contributing to pitches and proposals and partnering with the Biotech COE to showcase differentiated expertise. 

What You Should Have: 

• 6+ years of experience in medical affairs and ideally publications, in an agency setting.
• Minimum of 3 years of experience servicing biotech clients.
• Proven leadership skills, with experience managing client relationships and internal teams.
• Strong strategic thinking and problem-solving abilities, with a track record of driving account growth.
• Exceptional communication and presentation skills, with the ability to influence and engage stakeholders at all levels.
• Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment.
• Proficiency in financial management, including budget tracking and forecasting.
• Experience with Advisory boards, investigator meetings, and meeting management.
• Veeva management expertise (preferred but not required).
• Bachelor’s degree or equivalent work experience required. 

This position is a perfect fit for you if:  

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 
• You are a highly organized self-starter, able to work independently and under tight deadlines.  

About the Role >>> Senior Director, Global Regulatory Strategy 

As the Senior Director, Global Regulatory Strategy reporting to the Senior Vice President of Regulatory Affairs, your main responsibilities will include the following:  

• Leading the development and execution of innovative regulatory strategies supporting Olema products  
• Representing Regulatory Affairs on cross-functional teams as the subject matter expert and providing regulatory guidance and oversight to the global project teams
• Providing strategic and tactical guidance and leading the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, IMPD etc.)  

This role is based either out of our Boston, MA or San Francisco, CA office and will require domestic and international travel up to 20%. 

Your work will primarily encompass:  

• Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed  
• Represent Regulatory Affairs as the SME across cross-functional teams and provide regulatory guidance/oversight to the global project teams, Study Execution Teams, and the Executive Committee  
• Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices (e.g., companion diagnostics)  
• Be accountable for, provide both strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DSUR, IMPD etc.)  
• Represent Olema with global Health Authorities and lead Agency interactions to achieve company objectives  
• Proactively identify gaps and develop risk mitigation strategies for regulatory submissions in alignment with the team(s) and management 
• Ensure Olema’s regulatory activities are robust and in compliance with Health Authority (HA) regulatory requirements  
• Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams  
• Serve as the point of contact with external parties and vendors supporting regulatory activities (e.g., CROs, contractors etc)   
• Participate in and contribute to cross-functional and departmental objectives  
• Maintain flexibility to adapt and accommodate additional duties as assigned  

And will also include the following:  

• Lead the development of Regulatory Affairs department policies, SOPs, and work instructions  
• Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva)  
• Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives, policies and their potential impact on Olema’s programs  
• Lead the global Regulatory team(s) and ensure execution of the regulatory strategies to achieve company objectives  
• Mentor and develop colleagues in the Regulatory department   

Ideal Candidate Profile  >>> Innovative Experienced Regulatory Strategy Leader  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.  

Knowledge:  

• Bachelor’s degree in a scientific discipline  
• Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred   

Experience:  

• 12 years’ experience in Regulatory Affairs in Pharma/Biotech  
• Minimum of 3 years direct leadership experience  
• Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions  
• Experience with leading the NDA/BLA or Marketing Applications is desirable.) 
• Experience in Oncology Therapeutic area is required 
• Experience with development and execution of regulatory strategies in Oncology TA is required  
• Ability to work in a fast-paced environment in a hands-on fashion  
• Excellent oral, written, and presentation skills  
• Strong organizational skills  

Attributes:  

• Self-starter  
• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities

The base pay range for this position is expected to be $270,000 - $290,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-MK1

About the Role >>> Senior Director, Global Regulatory Strategy 

As the Senior Director, Global Regulatory Strategy reporting to the Senior Vice President of Regulatory Affairs, your main responsibilities will include the following:  

• Leading the development and execution of innovative regulatory strategies supporting Olema products  
• Representing Regulatory Affairs on cross-functional teams as the subject matter expert and providing regulatory guidance and oversight to the global project teams
• Providing strategic and tactical guidance and leading the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, IMPD etc.)  

This role is based either out of our Boston, MA or San Francisco, CA office and will require domestic and international travel up to 20%. 

Your work will primarily encompass:  

• Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed  
• Represent Regulatory Affairs as the SME across cross-functional teams and provide regulatory guidance/oversight to the global project teams, Study Execution Teams, and the Executive Committee  
• Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices (e.g., companion diagnostics)  
• Be accountable for, provide both strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DSUR, IMPD etc.)  
• Represent Olema with global Health Authorities and lead Agency interactions to achieve company objectives  
• Proactively identify gaps and develop risk mitigation strategies for regulatory submissions in alignment with the team(s) and management 
• Ensure Olema’s regulatory activities are robust and in compliance with Health Authority (HA) regulatory requirements  
• Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams  
• Serve as the point of contact with external parties and vendors supporting regulatory activities (e.g., CROs, contractors etc)   
• Participate in and contribute to cross-functional and departmental objectives  
• Maintain flexibility to adapt and accommodate additional duties as assigned  

And will also include the following:  

• Lead the development of Regulatory Affairs department policies, SOPs, and work instructions  
• Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva)  
• Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives, policies and their potential impact on Olema’s programs  
• Lead the global Regulatory team(s) and ensure execution of the regulatory strategies to achieve company objectives  
• Mentor and develop colleagues in the Regulatory department   

Ideal Candidate Profile  >>> Innovative Experienced Regulatory Strategy Leader  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.  

Knowledge:  

• Bachelor’s degree in a scientific discipline  
• Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred   

Experience:  

• 12 years’ experience in Regulatory Affairs in Pharma/Biotech  
• Minimum of 3 years direct leadership experience  
• Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions  
• Experience with leading the NDA/BLA or Marketing Applications is desirable.) 
• Experience in Oncology Therapeutic area is required 
• Experience with development and execution of regulatory strategies in Oncology TA is required  
• Ability to work in a fast-paced environment in a hands-on fashion  
• Excellent oral, written, and presentation skills  
• Strong organizational skills  

Attributes:  

• Self-starter  
• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities

The base pay range for this position is expected to be $270,000 - $290,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-MK1

Location: Boston, MA preferred

The salary range for the Director, Regulatory Strategy is expected to be between $210,000 and $235,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

The Senior MSL is a U.S. field-based role within Medical Affairs, reporting to the Executive Director, Medical Affairs. This role will be a core member of Tango’s growing field medical team during a critical phase of development.

The Senior MSL will be responsible for high‑quality scientific exchange, trial execution support, medical education, and insight generation across priority solid tumor indications, with an initial focus on pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC), and our evolving pipeline programs.

This role is ideal for an individual who wants to operate at the intersection of clinical development, external scientific engagement, and launch readiness in a late-emerging biotech environment, where individual impact is high and scientific accountability matters.

Your role

      Primary Focus: Solid tumors (pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC)

      Scientific Exchange & External Engagement

What You Bring

      Education & Experience

• 8 years of relevant experience with a bachelor’s degree, 6 years with a master’s degree, or 3 years with an advanced scientific or medical degree (e.g., PharmD, PhD, MD) Candidates with advanced clinical degrees (e.g., NP, PA) and significant oncology Medical Science Liaison experience will also be considered.
• Experience in PDAC, GI malignancies, or NSCLC strongly preferred
• Prior experience supporting clinical-stage or pre-launch oncology assets highly valued

      Skills & Attributes

• Strong scientific acumen with the ability to engage deeply on complex biology and emerging clinical data
• Demonstrated strength in insight generation, synthesis, and communication
• Comfortable operating in a fast-moving, high-accountability biotech environment
• Excellent collaboration skills across matrixed teams
• Strong understanding of U.S. clinical research and healthcare environments

      Compliance & Technical Requirements

• Working knowledge of FDA, OIG, ICH, GCP, PhRMA Code, and applicable compliance standards
• Commitment to compliant, ethical scientific exchange
• Proficiency in standard business and field tools (CRM, MS Office, virtual engagement platforms)

Work Environment

• Field-based role in Texas, with residence required within assigned territory
• ~ 50% domestic travel expected, with significant time spent with external scientific partners

Why Join Tango Medical Affairs?

• Be part of a Medical Affairs team built for a transition from mid-stage to late-stage development
• Contribute directly to trial success, data readiness, and future regulatory and commercialization pathways
• Expand and establish Tango as a credible clinical scientific leader in precision oncology
• Work in a lean, collaborative environment where your scientific judgment and execution matter

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Remote

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

The Senior MSL is a U.S. field-based role within Medical Affairs, reporting to the Executive Director, Medical Affairs. This role will be a core member of Tango’s growing field medical team during a critical phase of development.

The Senior MSL will be responsible for high‑quality scientific exchange, trial execution support, medical education, and insight generation across priority solid tumor indications, with an initial focus on pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC), and our evolving pipeline programs.

This role is ideal for an individual who wants to operate at the intersection of clinical development, external scientific engagement, and launch readiness in a late-emerging biotech environment, where individual impact is high and scientific accountability matters.

Your role

      Primary Focus: Solid tumors (pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC)

      Scientific Exchange & External Engagement

What You Bring

      Education & Experience

• 8 years of relevant experience with a bachelor’s degree, 6 years with a master’s degree, or 3 years with an advanced scientific or medical degree (e.g., PharmD, PhD, MD) Candidates with advanced clinical degrees (e.g., NP, PA) and significant oncology Medical Science Liaison experience will also be considered.
• Experience in PDAC, GI malignancies, or NSCLC strongly preferred
• Prior experience supporting clinical-stage or pre-launch oncology assets highly valued

      Skills & Attributes

• Strong scientific acumen with the ability to engage deeply on complex biology and emerging clinical data
• Demonstrated strength in insight generation, synthesis, and communication
• Comfortable operating in a fast-moving, high-accountability biotech environment
• Excellent collaboration skills across matrixed teams
• Strong understanding of U.S. clinical research and healthcare environments

      Compliance & Technical Requirements

• Working knowledge of FDA, OIG, ICH, GCP, PhRMA Code, and applicable compliance standards
• Commitment to compliant, ethical scientific exchange
• Proficiency in standard business and field tools (CRM, MS Office, virtual engagement platforms)

Work Environment

• Field-based role in the Northeast (Boston/New York), with residence required within assigned territory
• ~ 50% domestic travel expected, with significant time spent with external scientific partners

Why Join Tango Medical Affairs?

• Be part of a Medical Affairs team built for a transition from mid-stage to late-stage development
• Contribute directly to trial success, data readiness, and future regulatory and commercialization pathways
• Expand and establish Tango as a credible clinical scientific leader in precision oncology
• Work in a lean, collaborative environment where your scientific judgment and execution matter

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Remote

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

The Senior MSL is a U.S. field-based role within Medical Affairs, reporting to the Executive Director, Medical Affairs. This role will be a core member of Tango’s growing field medical team during a critical phase of development.

The Senior MSL will be responsible for high‑quality scientific exchange, trial execution support, medical education, and insight generation across priority solid tumor indications, with an initial focus on pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC), and our evolving pipeline programs.

This role is ideal for an individual who wants to operate at the intersection of clinical development, external scientific engagement, and launch readiness in a late-emerging biotech environment, where individual impact is high and scientific accountability matters.

Your role

      Primary Focus: Solid tumors (pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC)

      Scientific Exchange & External Engagement

What You Bring

      Education & Experience

• 8 years of relevant experience with a bachelor’s degree, 6 years with a master’s degree, or 3 years with an advanced scientific or medical degree (e.g., PharmD, PhD, MD) Candidates with advanced clinical degrees (e.g., NP, PA) and significant oncology Medical Science Liaison experience will also be considered.
• Experience in PDAC, GI malignancies, or NSCLC strongly preferred
• Prior experience supporting clinical-stage or pre-launch oncology assets highly valued

      Skills & Attributes

• Strong scientific acumen with the ability to engage deeply on complex biology and emerging clinical data
• Demonstrated strength in insight generation, synthesis, and communication
• Comfortable operating in a fast-moving, high-accountability biotech environment
• Excellent collaboration skills across matrixed teams
• Strong understanding of U.S. clinical research and healthcare environments

      Compliance & Technical Requirements

• Working knowledge of FDA, OIG, ICH, GCP, PhRMA Code, and applicable compliance standards
• Commitment to compliant, ethical scientific exchange
• Proficiency in standard business and field tools (CRM, MS Office, virtual engagement platforms)

Work Environment

• Field-based role in California, with residence required within assigned territory
• ~ 50% domestic travel expected, with significant time spent with external scientific partners

Why Join Tango Medical Affairs?

• Be part of a Medical Affairs team built for a transition from mid-stage to late-stage development
• Contribute directly to trial success, data readiness, and future regulatory and commercialization pathways
• Expand and establish Tango as a credible clinical scientific leader in precision oncology
• Work in a lean, collaborative environment where your scientific judgment and execution matter

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Remote

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

In this newly created role, the Scientific Director, Medical Information & Medical Communications will serve as a senior individual contributor within Medical Affairs, responsible for owning the medical information foundation and scientific narrative across Tango’s pipeline.

This role will be central to ensuring Tango is prepared to support increasing external engagement, regulatory interactions, congress presence, publications, and future commercialization. This is an exciting opportunity to shape foundational capability during a period of significant clinical and organizational inflection.

Your role

     Medical Information Strategy & Operations

• Lead the end-to-end medical information strategy, including oversight of external MI vendors and call center operations
• Ensure timely, accurate, compliant, and evidence-based responses to external inquiries
• Develop, maintain, and govern medical information content, including SRLs, CRLs, FAQs, and response guidance
• Own medical information SOPs, KPIs, quality metrics, audit readiness, and inspection preparedness
• Ensure alignment with pharmacovigilance, regulatory, and compliance requirements

      Scientific Narrative & Medical Communications

• Develop and maintain Tango’s core scientific platform and data narrative across indications and development stages
• Translate complex clinical, nonclinical, and mechanistic data into clear and compelling content for internal and external audiences
• Ensure consistency of scientific messaging across medical information, field materials, congress assets, and internal communications

      Publications, Congress, & Content Governance

• Partner with Medical Affairs and Clinical teams to support publication planning and execution
• Oversee development of scientific materials for major medical congresses
• Provide medical information support at congresses, as appropriate
• Participate in the Medical Review process to ensure scientific accuracy, compliance, and data integrity

      Cross-Functional Collaboration

• Collaborate closely with Medical Affairs leadership, Clinical Development, Regulatory Affairs, Corporate Communications, and Commercial (as appropriate and compliant)
• Ensure alignment between scientific communications, medical strategy, and enterprise objectives
• Perform additional duties as required to support Medical Affairs goals

What You Bring 

• Advanced scientific degree required (PharmD, PhD, or MD strongly preferred)
• 7–10+ years of experience in Medical Affairs, Medical Information, or Scientific/Medical Communications
• Oncology experience strongly preferred; experience in GI malignancies, NSCLC, or precision oncology highly valued
• Experience in clinical-stage and/or pre-commercial biotech environments
• Exceptional scientific writing, editing, and data-positioning skills
• Strong understanding of clinical development, regulatory pathways, and medical affairs operations
• Demonstrated ability to manage vendors, agencies, and cross-functional stakeholders
• Experience with Veeva MedComms and PromoMats preferred
• Ability to operate effectively through ambiguity in a resource-constrained environment
• Excellent written and oral communication skills

Work Environment

• This role may be remote, with periodic travel to Tango offices and scientific meetings
• Approximately 10–20% travel

#LI-Remote

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Description of Role

Key Responsibilities

Strategic Leadership & Oversight 

• Develop and execute a comprehensive pharmacovigilance (PV) strategy aligned with corporate objectives and regulatory expectations.
• Lead safety governance and benefit-risk management for small molecule assets across development and post-marketing.
• Ensure compliance with global PV regulations (FDA, EMA, ICH, MHRA, etc.).
• Provide strategic safety input into clinical trial designs, protocols, and regulatory submissions.
• Establish and oversee PV partnerships, vendors, and external collaborations. 

Operational & Regulatory Compliance 

• Lead the safety surveillance and signal detection process, ensuring timely identification and mitigation of safety risks.
• Oversee the preparation and submission of safety reports (e.g., DSURs, PSURs, RMPs, SUSARs, IND safety reports, 15-day alerts).
• Ensure robust case processing, signal evaluation, and risk management processes are in place.
• Represent the company in regulatory interactions regarding safety matters (FDA, EMA, etc.). 

Cross-Functional Collaboration 

• Work closely with Clinical Development, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams to integrate safety considerations into decision-making. 
• Partner with Regulatory Affairs to support new drug applications (NDAs) and marketing authorizations.
• Support DSMBs, advisory boards, and investigator meetings with safety expertise. 

Team Leadership & Development 

• Build and lead a high-performing pharmacovigilance team, fostering a culture of scientific excellence and compliance.
• Provide mentorship and guidance to internal safety professionals. 

Compensation

The annual base salary range for this position is $350,000.00 to $380,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Vice President, Pharmacovigilance and Safety role is based in the US, with occasional travel.

POSITION: Full-Time, Exempt

Description of Role

The Sr. MSL will serve as a field-based scientific expert responsible for engaging with healthcare professionals (HCPs), supporting clinical development, and ensuring alignment with Centessa’s strategic medical objectives. This role is critical in translating complex scientific data into meaningful clinical insights and fostering compliant, evidence-based dialogue with thought leaders.

Key Responsibilities

Scientific Expertise & Thought Leader Engagement

• Maintain a high level of therapeutic area expertise and scientific knowledge relevant to Centessa’s pipeline and marketed products in alignment with Medical Affairs strategic objectives
• Engage in compliant, non-promotional scientific exchange with key opinion leaders (KOLs), investigators, and other HCPs
• Serve as a trusted scientific resource to external stakeholders, providing accurate and balanced medical information
• Deliver company-approved, high-quality medical/scientific presentations to a variety of audiences including formulary committees and healthcare professionals.
• Provide medical/scientific support for critical Centessa activities including speaker training, advisory boards, and sales training as appropriate
• Ensure accurate, timely, and compliant documentation of field-based activities in accordance with MSL organization guidelines

Clinical Trials Support

• Collaborate with Clinical Operations to identify and evaluate potential clinical trial sites and investigators based on scientific expertise, patient population, and alignment with study objectives
• Provide scientific education and protocol-specific training to investigators and site staff during site initiation visits, ensuring thorough understanding of study rationale and endpoints
• Maintain ongoing engagement with trial sites and investigators to facilitate successful execution of clinical trial objectives, provide ongoing scientific support, address protocol-related inquiries, and ensure high-quality data generation

Medical Conference Attendance & Coverage

• Attend relevant scientific and medical congresses to stay current with emerging data and trends
• Provide real-time insights and post-conference reports to internal teams
• Support Centessa’s presence at congresses through development of pre-conference plans, booth coverage, symposia participation, and KOL engagement
• Senior MSLs will be responsible to leading strategic conference planning, execution, and reporting

Scientific Materials Development

• Contribute to the development of scientific slide decks, FAQs, and educational materials
• Writing and editing Medical Information response letters
• Ensure all materials are medically accurate, evidence-based, and compliant with regulatory standards
• Collaborate with Medical Affairs and Legal teams to ensure scientific content meets internal and external guidelines

Additional Responsibilities:

• Lead MSL strategic initiatives/projects aligned with Medical Affairs and MSL organization strategy
• Develop and implement scientific training plans for the MSL team
• Contribute to MSL organization strategy in collaboration with MSL leadership
• Mentorship of MSL peers

Qualifications

• Advanced degree (PhD, PharmD, MD, DP, PsyD, DNP) in life sciences or a related field (from An Accredited College or University).
• Minimum 4+ years' experience as an MSL for a drug development company in the pharmaceutical/biotech industry
• Demonstrated understanding of sleep medicine and/or associated neuroscientific areas required 
• Exceptional verbal and written communication skills; ability to tailor scientific messages to diverse audiences and ability to interpret and communicate complex scientific data
• Proven ability to build and maintain strong relationships with KOLs, investigators, and internal stakeholders
• Strong understanding of clinical trial design, regulatory requirements, and therapeutic area landscape
• Skilled in developing and delivering scientific presentations in various settings
• Strong understanding of industry regulations and guidelines governing medical interactions
• Ability to align field activities with broader medical and corporate strategies
• Senior MSLs have a proven ability to lead and mentor peers
• Must have a valid driver’s license with a driving record that meets company requirements
• Must reside within the New England region or the New York Metro area.
• Willing and able to travel frequently within assigned territory (Boston, New York, Philadelphia, Baltimore, Detroit, Cleveland, Cincinnati)

Compensation

The annual base salary range for the Senior MSL job level is $190,000 - $230,000.

Individual compensation within these ranges will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Sr. MSL - Northeast is a remote role based in the US, with up to 60-70% travel and occasional weekends

POSITION: Full-Time, Exempt

Description of Role

Centessa is seeking an experienced Senior Director, Clinical Pharmacology to provide scientific and strategic leadership for clinical pharmacology across a diverse pipeline spanning early development through late-stage and registrational programs. Reporting to the Executive Director, Clinical Pharmacology, this position is accountable for developing and executing clinical pharmacology strategies that address the unique challenges of neuroscience drug development, including CNS exposure, dose optimization, and translational relevance. The Senior Director partners closely with cross-functional teams and represents clinical pharmacology in regulatory interactions to enable efficient, data-driven advancement of therapies across our neuroscience portfolio.

Key Responsibilities

• Lead clinical pharmacology strategy for CNS and neuroscience programs from first‑in‑human through registrational and post‑marketing stages 
• Design, execute, and interpret clinical pharmacology studies, including FIH, multiple‑ascending dose, DDI, biopharmaceutics, and patient studies 
• Drive dose selection and optimization by integrating PK, PD, safety, efficacy, and CNS‑specific biomarkers  
• Lead model‑informed drug development, including population PK, PK/PD, and exposure–response analyses relevant to CNS targets and clinical safety
• Assess and guide strategies for CNS exposure, brain penetration, target engagement, and translational biomarkers  
• Serve as the clinical pharmacology lead on program teams, clinical sub‑teams, and trial working groups 
• Author and oversee clinical pharmacology sections of regulatory documents (e.g., INDs, CTAs, IBs, NDAs)  
• Represent clinical pharmacology in interactions with FDA and other global health authorities, supporting dose justification and labeling discussions  
• Partner closely with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs  
• Oversee CROs and external vendors conducting clinical pharmacology and modeling activities  
• Ensure timely communication and clear interpretation of clinical pharmacology results to internal stakeholders 
• Contribute to portfolio strategy, program prioritization, risk mitigation, and long‑range clinical development planning for CNS assets 
• Serve as a subject‑matter expert on clinical pharmacology 
• Mentor and develop clinical pharmacology talent as the pipeline and organization grow  
• Ensure high‑quality, submission‑ready documentation aligned with global regulatory standards 

Qualifications

• PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline 
• 8–12+ years of experience in clinical pharmacology within biopharma, with demonstrated impact in clinical drug development 
• Extensive experience developing and executing clinical pharmacology strategies for early‑ through late‑stage programs, including registrational support 
• Strong expertise in PK, PD, PK/PD integration, exposure–response analyses, and drug–drug interaction assessment 
• Demonstrated experience applying quantitative clinical pharmacology approaches (e.g., population PK, mechanistic PK/PD modeling) to inform CNS dose selection and optimization  
• Proficiency with clinical pharmacology tools and platforms such as NONMEM, R, Phoenix WinNonlin, SimCyp, or equivalent 
• Experience authoring and delivering clinical pharmacology components of regulatory submissions (e.g., INDs, CTAs, NDAs) and interacting with global health authorities  
• Strong understanding of translational PK, CNS exposure considerations, and biomarker integration in neuroscience drug development  
• Excellent communication, collaboration, and leadership skills with the ability to operate effectively in a fast‑paced, matrixed environment 

Compensation 

The annual base salary range for this position is $270,000.00 to $295,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. 

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. 

Work Location

The Senior Director, Clinical Pharmacology role is a remote role based in the US, with occasional travel. 

POSITION: Full-Time, Exempt

SUMMARY:

Centessa continues to expand its CMC group and currently seeks an Executive Director of CMC, to lead our small molecule development programs across all CMC functions. This individual will be responsible for driving technical strategies, managing outsourced manufacturing partnerships, and overseeing all aspects of CMC development from early-to late-stage development and clinical studies. This high-impact leadership role requires a blend of scientific expertise, operational savvy, business acumen, technical efficiency, and strategic foresight. The ideal candidate brings deep experience in small molecule drug development, excels at cross-functional collaboration, and thrives in a growth-stage biotech environment.

The Executive Director, CMC will report directly to the SVP, CMC and will have ownership across the CMC function to include strategy, direct reports, team management, cross-functional leadership, and external manufacturing on our pipeline programs. Travel to vendors both domestically and internationally will be required.

RESPONSIBILITIES:

Strategic Leadership

• Oversee the implementation of end-to-end CMC strategy across Centessa’s development programs
• Translate development goals into robust CMC plans, ensuring alignment across R&D/early stage, Clinical, Quality, and Regulatory functions
• Develop long-term development manufacturing strategies that consider Phase 1/Phase 2 forecasting, demand forecasting, investment planning, inventory control, and vendor relationships
• Proactively identify and mitigate technical, production, and supply chain risks

Operational Oversight

• Act as the CMC team representative member in cross-functional developmental teams
• Oversee outsourced manufacturing activities, including CDMO contract negotiations and performance management
• Ensure timely delivery of clinical supply and maintain timelines for Registration/Primary Stability, PPQ/Commercial, and Phase 1/Phase 2 drug substance and drug product batches.
• Manage the development of budgets and timelines for CMC operations and report regularly to leadership
• Drive cross-functional meetings and milestone planning to support timely execution across drug substance and drug product for development programs
• Interface closely with key stakeholders in Quality, Regulatory, Supply Chain, Clinical, Legal, Finance, Project Management, and Non-Clinical teams in the development and execution of CMC plans
• Assist in developing documents and maintain compliance consistent with GLP and GMP standards for pre-clinical, early- and late-stage clinical development (pre-IND through Phase 3+)
• Develop and oversee SOPs, protocols/reports, and phase-appropriate specifications for pharmaceutical development and manufacturing activities
• Oversee technical transfer activities of API and drug product for supply chain resilience

Manufacturing and Technical Execution

• Supervise drug substance and drug product manufacturing and coordination of labeling, packaging, and distribution
• Oversee sourcing, planning, and logistics for raw materials, APIs, excipients, and required specialized critical reagents or equipment to meet production requirements
• Manage analytical method development and validation for starting materials, in-process controls, and final release and stability
• Participate in manufacturing site visits and pre-approval inspection readiness initiatives
• Identify, select, and manage CDMOs for process optimization, non-GMP and GMP manufacture and supply of API and drug product in support of ongoing pre-clinical and clinical programs, including delivery of scalable and cost-effective manufacturing routes that meet business requirements

Regulatory Affairs

• Collaborate with Regulatory Affairs to support the preparation and submission of CMC sections (INDs, IMPDs, NDAs, etc)
• Address CMC-related and pertinent cross-functional questions from regulatory authorities and ensure submission and response timelines are met

QUALIFICATIONS:

• Thorough understanding of cGMP requirements for pharmaceutical products
• Strong organizational, interpersonal, leadership, and decision-making skills
• Ability to work independently in a fast-paced dynamic environment with multiple projects and competing priorities
• Demonstrated ability to coordinate CDMO activities in the development and commercialization of pharmaceutical products
• Excellent organizational skills, project management skills and detail-orientated leadership approach
• Strong experience with chemical and physical characterization of small molecules
• Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions
• Understanding of product quality attributes control strategies as applied to small molecule synthetic processes

EXPERIENCE:

• Master’s degree in Organic Chemistry, Pharmaceutics, Chemical Engineering, or related scientific discipline (PhD strongly preferred).
• Minimum 18 years of pharmaceutical industry experience including at least 8 years in CMC. 
• Strong track record in CMC leadership across small molecule early-phase development and late-stage filing activities, including management of US and international CDMOs
• Extensive experience working with CDMOs and managing external partnerships
• In-depth knowledge of cGMP regulations and best practices in both clinical and commercial manufacturing
• Demonstrated success in process development, scale-up, and validation
• Prior experience drafting and submitting CMC content for regulatory filings in the U.S. and international markets, and interacting with global health authorities (IND, IMPD, NDA, MAA)
• Strong communication, project management, and organizational skills
• Proven ability to lead cross-functional teams in a fast-paced, evolving environment
• Strong skills in identifying and resolving critical issues
• Strong track record in effectively working with senior management

Compensation

The annual base salary range for this job level is $300,000 - $340,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

POSITION: Full-Time, Exempt

Job Title: QA/RA Consultant
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $130,000 - $150,000, plus equity options. (Compensation dependent on experience level)

As a Ketryx QA/RA Consultant, you will lead quality management system implementations and regulatory compliance strategies for cutting-edge medical device clients as we scale our AI-powered compliance platform. This is a rare opportunity to shape the future of regulatory affairs. You'll have the autonomy and expertise to drive repeatable QMS deployment processes while helping shape the future of regulatory affairs through innovative technology and enabling the success of the world’s most innovative companies. We offer the opportunity to work with high-growth clients, establishing best-in-class quality systems from the ground up using our revolutionary AI platform.

Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about regulatory excellence, and eager to leverage cutting-edge AI technology will thrive in this position. In this role, you'll have the opportunity to directly impact our mission to improve 100 million patient lives by 2030 by ensuring the highest quality standards for life-saving medical devices.

This position will be based in our Boston, Massachusetts office with a hybrid schedule (Monday, Tuesday, Thursday, Friday in office, Wednesday WFH option). Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of employment Visas (including H-1B), F-1 visas, or Optional Practical Training (OPT) status at this time.

About You:

You're a proven QMS expert who's successfully navigated complex medical device regulatory landscapes and is ready to scale your impact through innovative technology. You've built or significantly improved quality systems at medical device companies, consulting firms, or high-growth startups, and you're excited to combine your regulatory expertise with AI-powered tools to create something category-defining.

Responsibilities:

• Lead Quality Management System (QMS) setup and deployment for medical device clients.
• Own and manage QMS templates and regulatory compliance frameworks.
• Provide expert consulting on ISO 13485, MDSAP, GxP, and other quality systems standards.
• Scale operations to support high-growth clients.
• Develop repeatable QMS deployment processes leveraging AI platform capabilities and automatic compliance.
• Shape the future of regulatory affairs through innovative product development.
• Work independently on complex quality assurance projects requiring minimal oversight.
• Ensure customer success across the entire customer engagement lifecycle.

Required Skills:

• 4-8 years of experience in quality systems management, management representative or senior specialist role.
• Familiar with eQMS implementation, validation and implementation.
• Deep expertise in Quality Management System setup, sub-systems, and implementation.
• Strong knowledge of ISO 13485 and Global QMS requirements.
• Expertise in AI, Digital, and Cyber Compliance.
• Deep understanding of medical device cybersecurity.
• Experience as quality management representative in regulated environments.
• Experience with regulatory and Notified Body submission requirements.
• Background in medical device industry quality systems.
• Ability to work independently and own complex regulatory projects.
• Proven track record in consulting or client-facing roles.

Preferred Skills:

• Experience at large medical device companies (Stryker, Medtronic, Boston Scientific).
• Background with consulting firms specializing in QMS setup.
• Startup experience (Series A/B) with QMS implementation.
• Specializations in cybersecurity, usability, or computer software validation.
• Experience scaling quality operations in high-growth environments.
• Knowledge of AI applications in regulatory affairs.
• Submission experience.
• Experience working in an early stage, product-based start up.

Keywords: ISO 13485, MDSAP, Quality Management System (QMS), Management representative, Medical device quality, Stryker, Medtronic, Boston Scientific, QMS setup, Regulatory consulting, Quality systems manager, Computer software validation, Cybersecurity, Usability, Startup experience, Series A/B, Boston/Massachusetts, Consulting firms, Quality assurance, Medical device industry

Job Title: Delivery and Success Manager 
Employment Status: Full-time
Office Hours: Monday - Friday; 4:1 hybrid schedule
Location: Boston, Massachusetts
Compensation: $90,000 - $115,000 base + variable + equity options
*compensation may be negotiated based on experience level

About Ketryx:

Ketryx is an AI software platform that enables healthcare life sciences companies to ship life-saving regulated products in weeks instead of years.

Exploding product complexity is burying companies in compliance paperwork and blocking innovation. Our AI software removes this friction, dissolving the historical tradeoff between innovation and compliance, and enables regulated industries to innovate at the pace of modern software.

Just two years since launch, Ketryx already touches the lives of 25M patients and powers 3 of the world’s top 5 MedTech companies and 25% of the Fortune 500 MedTech market. Backed by Lightspeed Ventures, our founders are the former Head of AI at Amgen and CTO of Wolfram Cloud.

Healthcare and life sciences is just the beginning for us. Automotive, aerospace, energy — if it’s regulated, it’s because society decided it matters. These products move humanity, shape our future, and are safety-critical. Come join us and help build the AI platform to power safe innovation.

The Role

As a Delivery and Success Manager at Ketryx, you will lead strategic client engagements, guiding enterprise MedTech companies through onboarding and implementation. You’ll act as a trusted advisor, collaborating with regulatory and solutions experts to solve complex technical challenges and drive measurable business value.

This role is ideal for a self-starter who thrives in a fast-paced, high-growth environment and wants to make a direct impact on both clients and patient safety. You’ll have the autonomy to shape outcomes and grow your career as Ketryx continues to scale.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of employment Visas (including H-1B), F-1 visas, or Optional Practical Training (OPT) status at this time.

Responsibilities

Client Leadership

• Lead key client relationships from onboarding to long-term partnership and success.
• Work as part of a team of SMEs, account managers, and consultative experts to deliver value across technical and regulatory domains.
• Act as a trusted advisor using strong consultative skills to identify challenges and drive measurable outcomes.
• Partner directly with customer stakeholders to facilitate strategic discussions, drive decision-making, and ensure alignment.
• Conduct onsite sessions to understand client workflows, process bottlenecks, and critical questions, mapping opportunities to optimize operations through Ketryx.

Implementation Excellence

• Manage multiple client portfolios, balancing priorities and deadlines.
• Partner with Engineering, Product, and Quality to align client needs with product evolution.
• Lead process improvements that enhance scalability, efficiency, and team performance.
• Facilitate workshops and training sessions to ensure the product meets user needs and drives tangible operational results.

Technical & Quality Expertise

• Collaborate closely with Quality SMEs and Solution Architects to implement tailored configurations and ensure clients meet both technical and regulatory requirements.
• Develop deep expertise in the Ketryx platform and regulated development workflows.
• Guide clients on platform configuration, documentation, and compliance practices.

Team Leadership & Culture

• Build and mentor high-performing teams.
• Foster a high-trust, accountable, and collaborative culture.

Required Skills

• 5–10 years in client-facing or operational leadership roles in SaaS, MedTech, or regulated industries.
• Experience leading cross-functional teams and managing complex portfolios.
• Familiarity with safety-critical or compliance-driven environments.
• Experience managing full implementation lifecycle: project planning, requirements gathering, migration, configuration, validation, go-live.
• Understanding of quality systems and regulatory frameworks (ISO 13485, ISO 14971, IEC 62304, 21 CFR Part 820).
• Technical fluency with software and quality processes.
• Outstanding communication and presentation skills with a demonstrated track record of influencing effectively at all levels of the organization.
• Ability to drive effective and influencing conversations at the program level; facilitate difficult discussions and be adept at handling objections.
• Ability to facilitate complex discussions, handle objections, and drive consensus.
• Bachelor’s degree in engineering, life sciences, or related field, or equivalent experience.

Preferred Skills

• Experience in customer success, professional services, or product operations in B2B SaaS.
• Background in quality, regulatory affairs, or systems engineering.
• Familiarity with Software as a Medical Device (SaMD).
• Experience working in an early stage, product-based start up.

Keywords: customer success, professional services, systems engineer, Solutions Architect, Software as a Medical Device, SaMD, product management, technology, client management, quality, regulatory, system engineer, B2B

Job Title: Delivery and Success Associate - Enterprise
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $62,000 - $75,000 base + variable + equity options
*compensation may be negotiated based on experience level

About Ketryx:

Ketryx is an AI software platform that enables healthcare life sciences companies to ship life-saving regulated products in weeks instead of years.

Exploding product complexity is burying companies in compliance paperwork and blocking innovation. Our AI software removes this friction, dissolving the historical tradeoff between innovation and compliance, and enables regulated industries to innovate at the pace of modern software.

Just two years since launch, Ketryx already touches the lives of 25M patients and powers 3 of the world’s top 5 MedTech companies and 25% of the Fortune 500 MedTech market. Backed by Lightspeed Ventures, our founders are the former Head of AI at Amgen and CTO of Wolfram Cloud.

Healthcare and life sciences is just the beginning for us. Automotive, aerospace, energy — if it’s regulated, it’s because society decided it matters. These products move humanity, shape our future, and are safety-critical. Come join us and help build the AI platform to power safe innovation.

The role

As a Delivery and Success Associate - Enterprise, you’ll work closely with customers who rely on Ketryx to manage safety‑critical and regulated development processes. This is a technical, engineering‑adjacent role.

You’ll support customers from onboarding through long‑term partnership, helping configure the Ketryx platform, supporting requirements and quality workflows, and applying structured problem solving to real challenges. You’ll develop a deep understanding of how regulated teams build, verify, and validate software.

This is an excellent opportunity for early‑career engineers or technically trained professionals who want exposure to regulated industries, verification & validation practices, and customer‑facing technical work, while growing alongside a mission‑driven team.

About you

You bring an engineering mindset to your work. You like understanding how systems fit together, why processes exist, and how to improve them. You’re comfortable learning complex concepts and applying structure and logic to ambiguous problems.

You’re excited by the opportunity to work close to engineering, quality, and regulated product development, while also collaborating directly with customers.

You’re curious, detail‑oriented, and motivated by meaningful work that has real‑world impact.

Responsibilities 

• Support Customer Success: Partner with clients during onboarding and ongoing use of the Ketryx platform, helping them apply best practices for requirements, verification, and quality workflows.
• Configure and Support the Platform: Assist with configuring Ketryx to align with customer development processes, including requirements traceability, documentation workflows, and validation artifacts.
• Apply Engineering & Quality Thinking: Help customers reason through leaving evidence, verification activities, and structured development processes commonly used in regulated and safety‑critical environments.
• Troubleshoot and Problem‑Solve: Investigate technical and workflow challenges, escalate thoughtfully when needed, and follow through to resolution.
• Collaborate Cross‑Functionally: Share customer insights with Product, Engineering, and Quality teams to help improve the platform and internal processes.
• Support Quality & Compliance Efforts: Contribute to accurate, well‑structured documentation within the Quality Management System (QMS) and reinforce strong process discipline.
• Grow Your Technical Skill Set: Build fluency in regulated software development concepts such as requirements management, verification & validation (V&V), and the V‑model.

Required Skills

• Technical or Engineering Background: Bachelor’s degree in engineering, computer science, or a related technical field (or equivalent hands‑on technical experience).
• Exposure to Structured Development: Familiarity with concepts such as requirements, verification & validation, testing, systems engineering, or the V‑model (academic or professional exposure is sufficient).
• Interest in Regulated Industries: Curiosity about or comfort working in regulated, safety‑critical environments (medical devices, biotech, pharma, aerospace, automotive, etc.). Prior regulated experience is a plus, not a requirement.
• Technical Communication Skills: Ability to understand and explain technical concepts clearly, both verbally and in writing.
• Analytical Problem‑Solving: Comfort troubleshooting issues, asking good questions, and reasoning through complex workflows.
• Collaborative Mindset: Enjoys working across teams and building trusted relationships with customers and teammates.

Preferred Skills

• Experience in customer success, professional services, or product operations in B2B SaaS.
• Background in quality, regulatory affairs, or systems engineering.
• Familiarity with Software as a Medical Device (SaMD).
• Experience working in an early stage, product-based start up.

Keywords: customer success, client operations, delivery and success, professional services, systems engineer, Solutions Architect, Software as a Medical Device, SaMD, product management, technology, client management, quality, regulatory, system engineer, B2B, regulation, task management, project management, Greater Boston, MA, SQL, KQL, python, java

At Vynamic, we partner with leading pharmaceutical and life sciences companies to address critical strategic, operational, and organizational challenges—from early-stage planning through commercialization and beyond. Our Directors serve as trusted advisors to senior client stakeholders, shaping strategy, leading high-impact engagements, and driving measurable outcomes.

We are looking for individuals who bring deep industry knowledge, strong business acumen, and the ability to translate evolving market dynamics into actionable solutions. Our work spans key service areas including Strategic Planning, Vendor Selection & Management, Process Design, Systems Implementation, and Organizational Change.

What you'll be doing:

• Serve as a strategic advisor to pharmaceutical and life sciences clients, aligning engagement objectives with business priorities across the product lifecycle
• Lead complex engagements spanning areas such as commercialization strategy, launch planning, operating model design, and transformation initiatives
• Build and maintain strong relationships with senior stakeholders across functions (e.g., Commercial, Medical Affairs, Market Access, R&D, and Operations)
• Drive execution of client initiatives, ensuring high-quality deliverables and measurable business impact
• Identify emerging client needs and industry trends (e.g., market access pressures, digital transformation, evolving regulatory landscape) and translate them into new opportunities
• Contribute to business development efforts by expanding existing accounts and supporting new client acquisition
• Lead, mentor, and develop high-performing teams, fostering ownership, growth, and a collaborative culture
• Ensure clarity, rigor, and quality in all client deliverables, including executive-level presentations and strategic recommendations
• Proactively manage risks, timelines, and competing priorities across multiple engagements
• Build Vynamic’s presence in the pharma sector through thought leadership, industry insights, and participation in relevant forums
• Support recruiting efforts by engaging with and attracting top talent to the firm
• Foster a culture aligned with Vynamic’s values, emphasizing collaboration, excellence, and impact

What you'll need:

• Bachelor’s degree with 6–8+ years of experience at a leading consulting firm (life sciences-focused consulting experience preferred)
• Demonstrated experience leading engagements within the pharmaceutical or life sciences industry
• Deep understanding of the pharmaceutical value chain, including drug development, commercialization, market access, and lifecycle management
• Experience in one or more of Vynamic’s core service areas, with application in pharma contexts:
  • Strategic Planning (e.g., portfolio strategy, launch readiness)
  • Vendor Selection & Management (e.g., outsourcing models, partner ecosystems)
  • Process Design (e.g., commercial operations, medical affairs processes)
  • Systems Implementation (e.g., CRM, data & analytics platforms)
  • Organizational Change (e.g., transformations, operating model shifts)
• Strong executive presence with the ability to influence and advise senior client stakeholders
• Proven ability to identify, shape, and convert business development opportunities
• Excellent communication and presentation skills, with experience engaging executive audiences
• Demonstrated ability to lead teams, develop talent, and drive high performance
• Strong problem-solving skills, intellectual curiosity, and comfort with ambiguity
• Resilience and adaptability in fast-paced, evolving environments
• Alignment with and embodiment of Vynamic’s brand and values

Inizio Ignite, Vynamic 

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Vynamic management consulting team connects strategy to action, driving healthcare transformation. We partner with leading health and life science companies serving brand & commercial, Medical Affairs, R&D, and Health Services. Our expertise spans offerings including strategic planning & mobilization (SP&M), operating model & organization design (OMOD), deal activation & partnership enablement (DAPE), product launch strategy & planning, customer experience transformation, tech & digital transformation, strategic project management office, and change management. Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward

Further Information

This is a full-time role and will follow a hybrid work environment in either Boston, Philadelphia, or New York City.

#LI-ND1

#LI-Hybrid

At Vynamic, we partner with leading pharmaceutical and life sciences companies to address critical strategic, operational, and organizational challenges—from early-stage planning through commercialization and beyond. Our Directors serve as trusted advisors to senior client stakeholders, shaping strategy, leading high-impact engagements, and driving measurable outcomes.

We are looking for individuals who bring deep industry knowledge, strong business acumen, and the ability to translate evolving market dynamics into actionable solutions. Our work spans key service areas including Strategic Planning, Vendor Selection & Management, Process Design, Systems Implementation, and Organizational Change.

What you'll be doing:

• Serve as a strategic advisor to pharmaceutical and life sciences clients, aligning engagement objectives with business priorities across the product lifecycle
• Lead complex engagements spanning areas such as commercialization strategy, launch planning, operating model design, and transformation initiatives
• Build and maintain strong relationships with senior stakeholders across functions (e.g., Commercial, Medical Affairs, Market Access, R&D, and Operations)
• Drive execution of client initiatives, ensuring high-quality deliverables and measurable business impact
• Identify emerging client needs and industry trends (e.g., market access pressures, digital transformation, evolving regulatory landscape) and translate them into new opportunities
• Contribute to business development efforts by expanding existing accounts and supporting new client acquisition
• Lead, mentor, and develop high-performing teams, fostering ownership, growth, and a collaborative culture
• Ensure clarity, rigor, and quality in all client deliverables, including executive-level presentations and strategic recommendations
• Proactively manage risks, timelines, and competing priorities across multiple engagements
• Build Vynamic’s presence in the pharma sector through thought leadership, industry insights, and participation in relevant forums
• Support recruiting efforts by engaging with and attracting top talent to the firm
• Foster a culture aligned with Vynamic’s values, emphasizing collaboration, excellence, and impact

What you'll need:

• Bachelor’s degree with 6–8+ years of experience at a leading consulting firm (life sciences-focused consulting experience preferred)
• Demonstrated experience leading engagements within the pharmaceutical or life sciences industry
• Deep understanding of the pharmaceutical value chain, including drug development, commercialization, market access, and lifecycle management
• Experience in one or more of Vynamic’s core service areas, with application in pharma contexts:
  • Strategic Planning (e.g., portfolio strategy, launch readiness)
  • Vendor Selection & Management (e.g., outsourcing models, partner ecosystems)
  • Process Design (e.g., commercial operations, medical affairs processes)
  • Systems Implementation (e.g., CRM, data & analytics platforms)
  • Organizational Change (e.g., transformations, operating model shifts)
• Strong executive presence with the ability to influence and advise senior client stakeholders
• Proven ability to identify, shape, and convert business development opportunities
• Excellent communication and presentation skills, with experience engaging executive audiences
• Demonstrated ability to lead teams, develop talent, and drive high performance
• Strong problem-solving skills, intellectual curiosity, and comfort with ambiguity
• Resilience and adaptability in fast-paced, evolving environments
• Alignment with and embodiment of Vynamic’s brand and values

Inizio Ignite, Vynamic 

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Vynamic management consulting team connects strategy to action, driving healthcare transformation. We partner with leading health and life science companies serving brand & commercial, Medical Affairs, R&D, and Health Services. Our expertise spans offerings including strategic planning & mobilization (SP&M), operating model & organization design (OMOD), deal activation & partnership enablement (DAPE), product launch strategy & planning, customer experience transformation, tech & digital transformation, strategic project management office, and change management. Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward

Further Information

This is a full-time role and will follow a hybrid work environment in either Boston, Philadelphia, or New York City.

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#LI-Hybrid

At Vynamic, we partner with leading pharmaceutical and life sciences companies to address critical strategic, operational, and organizational challenges—from early-stage planning through commercialization and beyond. Our Directors serve as trusted advisors to senior client stakeholders, shaping strategy, leading high-impact engagements, and driving measurable outcomes.

We are looking for individuals who bring deep industry knowledge, strong business acumen, and the ability to translate evolving market dynamics into actionable solutions. Our work spans key service areas including Strategic Planning, Vendor Selection & Management, Process Design, Systems Implementation, and Organizational Change.

What you'll be doing:

• Serve as a strategic advisor to pharmaceutical and life sciences clients, aligning engagement objectives with business priorities across the product lifecycle
• Lead complex engagements spanning areas such as commercialization strategy, launch planning, operating model design, and transformation initiatives
• Build and maintain strong relationships with senior stakeholders across functions (e.g., Commercial, Medical Affairs, Market Access, R&D, and Operations)
• Drive execution of client initiatives, ensuring high-quality deliverables and measurable business impact
• Identify emerging client needs and industry trends (e.g., market access pressures, digital transformation, evolving regulatory landscape) and translate them into new opportunities
• Contribute to business development efforts by expanding existing accounts and supporting new client acquisition
• Lead, mentor, and develop high-performing teams, fostering ownership, growth, and a collaborative culture
• Ensure clarity, rigor, and quality in all client deliverables, including executive-level presentations and strategic recommendations
• Proactively manage risks, timelines, and competing priorities across multiple engagements
• Build Vynamic’s presence in the pharma sector through thought leadership, industry insights, and participation in relevant forums
• Support recruiting efforts by engaging with and attracting top talent to the firm
• Foster a culture aligned with Vynamic’s values, emphasizing collaboration, excellence, and impact

What you'll need:

• Bachelor’s degree with 6–8+ years of experience at a leading consulting firm (life sciences-focused consulting experience preferred)
• Demonstrated experience leading engagements within the pharmaceutical or life sciences industry
• Deep understanding of the pharmaceutical value chain, including drug development, commercialization, market access, and lifecycle management
• Experience in one or more of Vynamic’s core service areas, with application in pharma contexts:
  • Strategic Planning (e.g., portfolio strategy, launch readiness)
  • Vendor Selection & Management (e.g., outsourcing models, partner ecosystems)
  • Process Design (e.g., commercial operations, medical affairs processes)
  • Systems Implementation (e.g., CRM, data & analytics platforms)
  • Organizational Change (e.g., transformations, operating model shifts)
• Strong executive presence with the ability to influence and advise senior client stakeholders
• Proven ability to identify, shape, and convert business development opportunities
• Excellent communication and presentation skills, with experience engaging executive audiences
• Demonstrated ability to lead teams, develop talent, and drive high performance
• Strong problem-solving skills, intellectual curiosity, and comfort with ambiguity
• Resilience and adaptability in fast-paced, evolving environments
• Alignment with and embodiment of Vynamic’s brand and values

Inizio Ignite, Vynamic 

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Vynamic management consulting team connects strategy to action, driving healthcare transformation. We partner with leading health and life science companies serving brand & commercial, Medical Affairs, R&D, and Health Services. Our expertise spans offerings including strategic planning & mobilization (SP&M), operating model & organization design (OMOD), deal activation & partnership enablement (DAPE), product launch strategy & planning, customer experience transformation, tech & digital transformation, strategic project management office, and change management. Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward

Further Information

This is a full-time role and will follow a hybrid work environment in either Boston, Philadelphia, or New York City.

#LI-ND1

#LI-Hybrid

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

The Director, Regulatory Systems and Operations, reporting to our Chief Regulatory Officer, serves as a strategic leader and driver of regulatory infrastructure and execution. This role partners cross-functionally with internal stakeholders to define, implement, and continuously enhance Regulatory Information Management (RIM) systems and databases, ensuring the integrity, accessibility, and scalability of all regulatory information and documentation.

In parallel, this leader plays a critical role within the global regulatory organization as co-lead of the Global Regulatory Subteam, with accountability for the strategic planning, coordination, and execution of regulatory deliverables. The Director ensures alignment of regulatory activities with development timelines and organizational priorities, driving cross-functional collaboration to deliver high-quality submissions on time.

This position works closely with the Regulatory Strategy Leads to proactively shape and advance regulatory plans across the product lifecycle, providing both strategic oversight and operational leadership to enable successful global regulatory outcomes.

Your role

Regulatory Systems

• Lead the implementation and optimization of the Regulatory Information Management System (RIMS), ensuring strong user adoption through effective training and support. Drive continuous improvement of regulatory processes and monitor key global metrics and compliance indicators to advance operational excellence.
• Interface with Tango’s IT, QA and R&D departments and with external partners (if applicable) on local regulatory system management related topics.
• Support optimization of publishing best practices and global submission standards in accordance with regulatory requirements worldwide.
• Build and maintain relationship with external vendor partners (e.g. publishing).
• Support system audit and/or GxP inspection or due diligence with regard to regulatory systems and regulatory documentation.
• Define global processes to ensure compliance with the regulation. Build regulatory policies and procedures and ensure that these processes are adhered to.

Regulatory Project Management

• Lead project management activities related to the preparation and tracking of regulatory documents/submissions.
• Co-lead and coordinate the Global Regulatory Sub-Team (GRST) for assigned programs, driving operational regulatory activities in partnership with the RA strategist. Lead GRST meetings, track key deliverables, and proactively manage risks and mitigation plans.
• Drive timelines and deliverables related to submission documents. Track progress and review project(s) tasks to meet deadlines. Point of contact re: timelines and status of submissions / approvals / responses and commitments globally.
• Lead the day-to-day operation of the Dossier Task Force/filing team and ensure compliance with dossier compilation and global submission processes.
• Establish clear ownership for project tasks, ensure that team members have the tools needed. Communicate process and document standards to stakeholders.
• Identify and communicate critical processes or issues in project(s) and develop solution strategies together with the regulatory lead and project team functional representatives and/or head of function, when relevant.
• Responsible for the overall publishing activities for the assigned product. Establish good relationship with publishing vendor. Ensure timely, high quality dossier assembly and publishing in accordance with Submission Content Plan.

What You Bring

• Minimum of 10 years of Regulatory Operations experience, with a BA/BS or equivalent required; advanced degree preferred
• Strong knowledge of Veeva RIM systems
• Demonstrated success in defining and implementing new operating standards and regulatory processes
• Extensive experience in Regulatory Affairs project management within drug development, including leading cross-functional development teams
• Deep expertise in regulatory publishing requirements and constraints, with hands-on experience managing submissions for IND, CTA, NDA, and MAA applications
• Solid understanding of electronic document management systems, regulatory databases, publishing platforms, and related technologies
• Self-motivated, adaptable, and innovative leader with the ability to prioritize, manage multiple projects, and thrive in a fast-paced, dynamic environment; strong problem-solving skills with the ability to develop and implement effective solutions
• Strong organizational and project management capabilities
• Excellent written and verbal communication skills, including presentation and facilitation 

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

Reporting to the Vice President, Investor Relations and Corporate Communications, we are hiring a strategic communicator to oversee Product and Pipeline Communications for vopimetostat, our lead PRMT5 inhibitor, and other oncology pipeline candidates. This is an opportunity to create and deliver communications programs in support of clinical data, development efforts, and potential patient benefits.

Your role

• Lead communications for vopimetostat, covering data, regulatory milestones, and commercial launch
• Develop cross-functional messaging
• Execute disease awareness, branded campaigns, integrations, and digital/social media initiatives
• Partner with Clinical Development and Operations team to support clinical trial communications, including development of digital assets
• Collaborate with Clinical Development, Medical Affairs, Patient Advocacy, Regulatory, Legal, IR, Internal Communications, and external partners
• Represent the function on integrated teams and contribute to business decisions
• Support executive engagement through media, speaking opportunities, and internal communications
• Manage issues proactively to protect reputation; use analytics to assess communication strategies

What You Bring

• Bachelor’s degree with 10 plus years of experience in public relations or communications within the pharmaceutical or biotech industry
• Strong understanding of oncology drug development, regulatory policy, medical meeting and publications strategy
• Expertise in issues management within drug development
• Ability to adapt quickly in fast-changing environments
• Demonstrated success working in cross-functional, matrixed teams with an enterprise approach
• Preferred qualifications: Public relations or communications experience in oncology

This is a Hybrid/Flexible role!

#LI-Hybrid

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Hybrid

Position Summary

The Senior Director of Marketing - Gene Therapy will serve as a key commercial leader responsible for driving the strategy across a portfolio of three commercial gene therapy products, with primary responsibility for sickle cell disease (SCD). This role shapes the brands, accelerates patient access, strengthens treatment center engagement, and ensures durable growth across a dynamic ecosystem of patients, caregivers, providers, payers, advocacy partners, and community stakeholders.

The Senior Director of Marketing will also own field training to ensure consistent messaging aligned to the marketing strategy. This individual will lead cross functional optimization efforts, support field execution, and serve as a visible ambassador for the company’s commitment to transforming outcomes in SCD and rare genetic diseases.

This role partners closely with Sales, Market Access, Patient Services, Medical Affairs, Patient & Community Education, and Regulatory to ensure best in class patient and customer support and brand leadership.

Responsibilities

Marketing

• Own the end-to-end brand strategy for Lyfgenia (Primary Focus) and drive portfolio level storytelling that reinforces the company’s leadership in gene therapy and its value to patients, providers, and payers (e.g., disease education, positioning, messaging, value proposition, and competitive differentiation.)
• Develop integrated marketing plans that accelerate appropriate adoption while honoring the history, lived experience, and cultural context of the SCD community.
• Lead development of branded and unbranded campaigns across HCP, patient, caregiver, advocacy, and treatment center audiences including multichannel educational and engagement strategies across patient, HCP, treatment centers, caregiver, and advocacy stakeholders.
• Partner with Field Leadership to strengthen patient pull‑through and end‑to‑end journey support - from treatment consideration through infusion - with messaging, tools, and strategic guidance, ensuring alignment and high‑quality customer engagement.
• Serve as marketing lead for real‑world insights generation, post‑launch optimization, and strategic response to emerging data and competitive shifts.
• Maintain consistent operational excellence and rigorous performance tracking across all marketed programs to diagnose brand performance, guide action, and maximize ROI.
• Partner on congress strategy, symposia planning, and strategic KOL engagements for SCD and rare genetic disorders.
• Chair or co‑lead cross‑functional teams related to brand planning, insight generation, competitive intelligence, and commercialization readiness.
• Lead and develop a high‑performing marketing team, fostering accountability, customer empathy, and operational excellence.
• Manage agencies and vendors, ensuring high‑quality deliverables and efficient use of marketing budget.

Training

• Own the strategic direction of field force training, including new hire and ongoing initiatives, ensuring the field organization is fully equipped to communicate the science, navigate the treatment journey, and support treatment centers with confidence and clarity.

Required Education, Experience, or Qualifications (or equivalent)

Required: 

• Bachelor’s degree required; MBA or advanced life sciences degree preferred.
• 15+ years in biopharma marketing, including launch or post launch leadership in rare disease, gene therapy, or cell therapy.
• Experience leading training initiatives.
• Strong understanding of the SCD landscape, patient journey, cultural and historical dynamics, and operational requirements for the delivery of gene therapy.
• Proven ability to build and execute integrated marketing strategies across HCP, patient, and payer audiences.
• Demonstrated leadership in highly agile, cross functional environments.
• Exceptional communication, strategic thinking, and stakeholder management.

Preferred: 

• Experience within Sickle Cell Disease, Beta-Thalassemia
• Experience in autologous cell and gene therapy

Key Competencies: 

• Strong strategic and analytical acumen required to drive sound, data-driven business decisions
• Ability to translate science into customer driven value
• Cultural competence and authenticity
• Strong influence without authority, including executive-level presence
• Ability to translate strategy into operational plans with discipline
• Genuine Customer and patient empathy
• Team leadership and talent development
• Excellent communication and partnership with internal and external partners  

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary

Reporting to the CHRO, the Director, Human Resources Business Partner (HRBP) provides HR leadership and consultation to client groups within multiple functions, including Regulatory, Corporate Strategy, Medical Affairs, and other key late-stage clinical areas. The HRBP is a trusted advisor to leaders, providing expert HR advice and advanced solutions that enable the achievement of business strategies by leveraging a significant understanding of the operating environment. This role drives talent management and helps architect and manage organizational change. The role is responsible for the delivery of HR programs and services such as talent/career development, leader coaching and consultation, employee relations, and performance management.

Your role

• Provides strategic HR leadership and expert guidance to assigned client groups, along with consultation and delivery of HR programs and services to achieve key business objectives
• Leverages previous experience and data to provide critical insights into business and talent trends that inform the overall business and HR priorities. Provides insights in a simple, creative, and relevant way that challenges current thinking, informs business decisions, and shows how decisions impact business outcomes
• Proactively defines, builds, and implements value-added HR strategies and solutions
• Advises functional leaders in solving complex issues related to organization design, development, and change leadership
• Establishes strategies and tactics to enable the business to attract, develop, and retain high-quality talent at all levels to support the growth objectives, opportunities, and strategies of the business
• Leads the strategic workforce planning efforts to ensure the people and talent strategy is in alignment with the organization's long range strategic plan (identification of long-term capability needs, talent acquisition and succession planning)
• Builds strong partnerships within the HR team to enhance the function’s effectiveness in providing solutions to key business needs and to roll out corporate-wide programs that enhance the overall employee experience and support growth and success of overall business strategy
• Works with clients to implement and manage key HR processes, such as year-end performance management (performance assessment, calibration, and compensation planning)
• Partners with Talent Acquisition (TA) to ensure TA strategy is in place to deliver on key hires and growth plans

What you bring

Education and Experience:

• Undergraduate degree in human resources or related, relevant discipline
• Typically requires 10 years of experience or the equivalent combination of education and experience
• Biotech experience required; late-stage or commercial-stage experience strongly preferred

Knowledge and Skills:

• Experience developing and implementing HR strategies
• Track record of developing strategic workforce plans, from conception to implementation
• Highly experienced in talent management, succession planning, and career growth and development
• Strong experience managing and/or leading culture and change management or organizational effectiveness initiatives
• Experience and expert understanding of management development, employee relations, data and analytics

Traits and Qualities:

• Ability to influence positively including in situations without direct authority
• Ability to work independently and collaboratively, in a matrix team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support, prioritize, and multi-task
• Highly collaborative team player who fosters open communication and develops important relationships with key stakeholders
• Outstanding interpersonal and communication abilities with a high degree of emotional intelligence
• Possess the ability, business maturity and interpersonal savvy to be proactive and establish credibility with all employees across the Company
• Have proven communication skills, both written and verbal, and the ability to present information clearly to a variety of audiences
• Able to learn quickly and take a project from idea to execution (strategy to operational) quickly and independently
• Thrives in high energy and fast paced organization with ongoing simultaneous initiatives
• Builds consensus and alignment and persuades others to take action

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We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

About the Position 

The Associate Director, Bioanalytical will lead bioanalytical strategy and delivery for assigned programs, working across nonclinical and clinical teams to ensure assays are fit for purpose and support key development decisions. The role will oversee external bioanalytical partners and drive execution for PK/TK, metabolites as applicable, biologics bioanalysis, and immunogenicity, including assay approach selection, validation strategy, sample analysis oversight, data review, and submission-ready documentation. In partnership with Clinical Pharmacology, DMPK/Nonclinical, Clinical Operations, Regulatory, and data teams, this role will help scale Formation Bio’s Trial Engine by standardizing bioanalytical workflows, improving traceability, and enabling consistent, analysis-ready bioanalytical outputs across programs.

Responsibilities

• Lead bioanalytical strategy and delivery for assigned programs across small molecules and biologics, aligned to clinical questions and decision points
• Define assay plans and validation approaches (fit-for-purpose through full validation) for PK/TK, metabolites as applicable, biologics bioanalysis, and immunogenicity
• Manage bioanalytical CROs and specialty labs for assigned workstreams: contribute to partner selection, define scopes, set timelines, and monitor performance, quality, and budget
• Oversee end-to-end bioanalytical execution: protocols, validation reports, sample analysis, data review, and final reports to support program decisions and filings
• Own day-to-day BA operating processes for assigned programs: assay lifecycle tracking, method transfer planning, issue triage, deviation management, and CAPA follow-up with vendors
• Ensure data quality and audit readiness for assigned deliverables through strong documentation practices, traceability, and alignment to regulatory guidance and internal standards
• Partner with Clinical Pharmacology and Clinical Development on study design inputs, sampling strategies, analyte panels, and interpretation of exposure and immunogenicity implications
• Coordinate with Clinical Operations on sample logistics (kits, handling, stability, chain of custody, reconciliation) and resolution of operational issues impacting bioanalysis
• Collaborate with Regulatory Affairs by drafting/reviewing submission components and providing technical input to support IND/CTA and NDA/BLA/MAA activities
• Align with DMPK/Nonclinical on bioanalytical approaches across studies and support translational PK needs
• Work with Biostatistics/Data Science to enable clean data transfers, consistent formats/metadata, and analysis-ready datasets
• Support diligence and asset evaluation by reviewing bioanalytical packages, identifying gaps/risks, and proposing pragmatic remediation plans
• Contribute to Trial Engine scaling by helping standardize templates, workflows, and reporting conventions that improve speed and consistency across programs

About You 

• PhD in a relevant field with 7+ years of bioanalytical experience in biopharma, including clinical-stage support, or a relevant undergraduate degree with 10+ years of experience
• Lead bioanalytical strategy and execution for assigned preclinical and clinical programs across small molecules and biologics
• Deep LC–MS/MS expertise for PK/TK, troubleshooting, and ISR
• Familiar with biologics bioanalysis and immunogenicity (ADA/NAb) approaches and interpretation
• Strong working knowledge of bioanalytical regulatory expectations and submission-quality documentation
• Lead CRO/vendor execution for assigned workstreams; support partner selection and governance as needed
• Comfortable operating in a fast-paced, cross-functional environment with multiple concurrent priorities
• Clear communicator who can translate technical detail into program-relevant recommendations
• Preferred: Experience functioning as part of a clinical study team to integrate tradeoffs between vendor selection, development speed, assay quality and performance, and applicability of method to deliver value to program overall
• Preferred: Familiarity with GCP/GCLP expectations and audit/inspection readiness for clinical bioanalysis
• Preferred: Experience shaping sample logistics (kits, stability, chain of custody) and data flow into filings

Total Compensation Range: $177,500 - $232,000

About the Position 

The Senior Director, Medical Affairs is a first-in-function leadership role responsible for building and leading Medical Affairs capabilities across Formation Bio’s growing portfolio. This role will establish the scientific foundation for programs spanning late-stage development to commercialization, with an initial focus on our lead asset, Sprifermin.

This leader will serve as a strategic scientific partner to Clinical Development, Regulatory, Commercial, and Portfolio teams, ensuring that Medical Affairs strategy, scientific exchange, and evidence generation are embedded early and executed with rigor, compliance, and credibility.

The Senior Director will design scalable medical affairs infrastructure, lead external scientific engagement, and build a high-impact Medical Affairs team—including the future build-out of a field-based Medical Science Liaison (MSL) team.

Responsibilities

Medical & Scientific Strategy

• • Lead medical affairs and scientific strategy across assigned programs, from late development through pre-launch and commercialization readiness.
  • Embed medical perspective early in development planning, including endpoint selection, evidence generation, and lifecycle strategy.
  • Provide medical and scientific input into asset diligence, in-licensing evaluations, and portfolio strategy.

External Scientific Engagement

• • Develop and execute a comprehensive KOL engagement strategy, building durable relationships with external experts, investigators, and scientific leaders.
  • Lead scientific exchange activities, including advisory boards, congress strategy, and external data communication.
  • Serve as a credible scientific leader representing Formation Bio programs externally with rigor and integrity.

Publications & RWE

• • Own publication planning and execution, ensuring timely, compliant dissemination of clinical and real-world data.
  • Support Phase IV, real-world evidence (RWE), and observational studies in partnership with Clinical and internal stakeholders.
  • Translate evidence into clear medical narratives that inform development, access, and launch readiness.

Medical Affairs Build-Out

• • Establish scalable medical affairs processes, governance, and operating models appropriate for a multi-asset organization.
  • Build and lead the Medical Affairs function over time, including the planned launch and management of a field-based Medical Science Liaison (MSL) team.
  • Balance internal capabilities with external vendors and partners to maximize efficiency and impact.

Launch & Cross-Functional Partnership

• • Support launch readiness through medical education strategy, scientific positioning, and internal training.
  • Provide medical affairs input into value narratives, HEOR strategy, and reimbursement dossiers in collaboration with cross-functional teams.

Patient & Advocacy Engagement

• • Develop strategy for engagement with patient advocacy groups and medical societies to inform development, education, and access.

About You 

• 10+ years of experience in Medical Affairs and/or Clinical Development within biopharma or biotech, with increasing leadership responsibility.
• Advanced scientific or clinical degree (PhD, PharmD, MD, or equivalent) strongly preferred.
• Demonstrated experience developing and executing medical strategy across late development, pre-launch, and commercialization.
• Experience building or scaling medical affairs capabilities, including MSL teams.
• Deep understanding of medical compliance, scientific exchange regulations, and industry best practices.
• Strong cross-functional partner with experience working closely with Clinical, Regulatory, Commercial, and Portfolio teams.
• Track record of credible external engagement with KOLs, investigators, and scientific stakeholders.
• Exceptional communication skills with the ability to synthesize complex data into clear strategic insights.
• Hands-on leadership style with comfort operating in a fast-growing, resource-lean environment.

Total Compensation Range: $325,000 - $425,000

About the Position 

The Associate Director, Drug Substance, Biologics, will provide technical, strategic and hands-on operational leadership for all CMC activities related to drug substance development and manufacturing, with a primary focus on Biologics at all stages of development (IND-enabling to commercialization).

The Associate Director, Drug Substance, will be responsible for overseeing the process development, manufacturing and release of drug substances at CDMOs ensuring manufacturing operations align with program timelines, quality standards, and regulatory requirements. This position requires deep expertise in biologics drug substance manufacturing (either cell culture or downstream purification), strong technical problem-solving abilities, and proven experience managing complex manufacturing operations with external partners. You will play a critical role in accelerating our mission of bringing new treatments to patients faster and more efficiently.

Responsibilities

Development and Manufacturing Strategy, Operations and Oversight

• • Lead drug substance manufacturing strategy and execution for programs from preclinical through commercial stages, ensuring alignment with program objectives, timelines, and budget constraints.
  • Serve as the primary technical interface with CDMOs for drug substance manufacturing activities. Establish and maintain strong partnerships, lead technical discussions, and ensure manufacturing excellence across external manufacturing network.
  • Oversee cell culture and downstream purification activities related to process development and manufacturing for both microbial and mammalian expression systems. Ensure manufacturing processes are robust, scalable, and compliant with cGMP requirements.
  • Provide technical guidance and oversight for manufacturing campaigns including batch record review and approval, deviation investigations, change control assessments, and resolution of manufacturing issues
  • Support scale-up activities from clinical to commercial manufacturing, including process optimization and validation. Identify and implement continuous improvement opportunities.
  • Develop comprehensive manufacturing plans and schedules in collaboration with Project Management, Clinical Supply, and Commercial teams. Track manufacturing timelines and proactively manage risks to ensure on-time delivery of drug substance for clinical trials and commercial supply.
  • Lead technical assessments and qualification of new CDMOs for drug substance manufacturing. Conduct site audits and ongoing performance monitoring. Manage relationships with multiple manufacturing partners across different geographic regions

Additional Core CMC Responsibilities (Quality, Regulatory & Cross-Functional)

• • Ensure all manufacturing activities comply with cGMP regulations, ICH guidelines, and internal quality standards. Support regulatory inspections and audits at manufacturing sites. Review and approve batch records, protocols, and manufacturing-related documentation.
  • Author and review CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing, process validation, and manufacturing site changes. Support responses to health authority questions.
  • Partner closely with Drug Product Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Clinical Supply, and Program Management leads to ensure seamless integration of manufacturing activities into overall program execution.
  • Collaborate with procurement to ensure timely contracting for drug substance manufacturing.

About You 

• MS or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related discipline.
• 6+ years of experience in the biopharmaceutical industry with hands-on experience in biologics drug substance manufacturing (either cell culture or downstream purification)
• Demonstrated track record of successfully managing drug substance manufacturing campaigns for biologics (proteins, monoclonal antibodies, antibody-drug conjugates, or other large molecules) from preclinical through late-stage clinical or commercial manufacturing.
• Technical expertise in either cell culture or downstream purification for process development, manufacturing, process characterization and process validation for biologics.
• Extensive experience working with CDMOs, including site selection, technology transfers, manufacturing oversight, and performance management. Proven ability to troubleshoot complex manufacturing issues and drive continuous improvement initiatives.

Total Compensation Range: $185,000 - $235,000

About the Position 

The Associate Director, Drug Product, will provide strategic and hands-on operational leadership for all CMC activities related to drug product development and manufacturing, with a primary focus on sterile injectables (lyophilized and liquid) at all stages of development (IND-enabling to commercialization).

The Associate Director, Drug Product, will be responsible for overseeing the formulation development, fill-finish, packaging, and release of drug products at CDMOs ensuring manufacturing operations align with program timelines, quality standards, and regulatory requirements. This position requires deep expertise in biologics drug product manufacturing, strong technical problem-solving abilities, and proven experience managing complex manufacturing operations with external partners. You will play a critical role in accelerating our mission of bringing new treatments to patients faster and more efficiently.

Responsibilities

Development and Manufacturing Strategy, Operations and Oversight

• Lead drug product manufacturing strategy and execution for programs from preclinical through commercial stages, ensuring alignment with program objectives, timelines, and budget constraints.
• Serve as the primary technical interface with CDMOs and contract manufacturing organizations for drug product manufacturing activities. Establish and maintain strong partnerships, lead technical discussions, and ensure manufacturing excellence across external manufacturing networks.
• Oversee formulation, aseptic fill-finish, lyophilization (if applicable), visual inspection, labeling, and packaging operations for drug products. Ensure manufacturing processes are robust, scalable, and compliant with cGMP requirements.
• Provide technical guidance and oversight for manufacturing campaigns including batch record review and approval, deviation investigations, change control assessments, and resolution of manufacturing issues
• Support scale-up activities from clinical to commercial manufacturing, including process optimization and validation. Identify and implement continuous improvement opportunities.
• Develop comprehensive manufacturing plans and schedules in collaboration with Project Management, Clinical Supply, and Commercial teams. Track manufacturing timelines and proactively manage risks to ensure on-time delivery of drug product for clinical trials and commercial supply.
• Lead technical assessments and qualification of new CDMOs for drug product manufacturing. Conduct site audits and ongoing performance monitoring. Manage relationships with multiple manufacturing partners across different geographic regions

Additional Core CMC Responsibilities (Quality, Regulatory & Cross-Functional)

• Ensure all manufacturing activities comply with cGMP regulations, ICH guidelines, and internal quality standards. Support regulatory inspections and audits at manufacturing sites. Review and approve batch records, protocols, and manufacturing-related documentation.
• Author and review CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing, process validation, and manufacturing site changes. Support responses to health authority questions.
• Partner closely with Drug Substance Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Clinical Supply, and Project Management leads to ensure seamless integration of manufacturing activities into overall program execution.
• Collaborate with procurement to ensure timely contracting for drug product manufacturing.

About You 

• MS or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related discipline.
• 6+ years of experience in the biopharmaceutical industry with hands-on experience in biologics drug product manufacturing, formulation development, and fill-finish operations.
• Demonstrated track record of successfully managing drug product manufacturing campaigns for biologics (proteins, monoclonal antibodies, antibody-drug conjugates, or other large molecules) from preclinical through late-stage clinical or commercial manufacturing.
• Technical expertise in aseptic fill-finish operations, lyophilization processes, formulation development, stability programs, and drug product characterization for biologics.
• Extensive experience working with CDMOs and contract manufacturing organizations, including site selection, technology transfers, manufacturing oversight, and performance management. Proven ability to troubleshoot complex manufacturing issues and drive continuous improvement initiatives.
• Strong knowledge of cGMP regulations, FDA and EMA guidelines, ICH quality guidelines, and regulatory expectations for drug product manufacturing.
• Experience authoring and reviewing CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing and validation activities.
• Strong project management skills with demonstrated ability to manage multiple manufacturing programs simultaneously, meet aggressive timelines, and navigate competing priorities.
• Excellent communication and interpersonal skills with ability to influence and build strong relationships with internal stakeholders and external manufacturing partners.
• Willingness to travel domestically and internationally (approximately 20-30%) to manufacturing sites for audits, manufacturing oversight, and technical meetings.

Total Compensation Range: $177,000 - $235,000

ESSENTIAL JOB FUNCTIONS:

The Senior Director, Medical & Regulatory Writing serves as subject matter expert on clinical protocols, protocol amendments, clinical study reports, Investigator’s Brochures, and briefing books. May also provide guidance on document strategy for more complex dossiers for regulatory submission such as IND and NDA/BLA filings. This role leads and is accountable for the Medical Writing and Clinical Trial Transparency & Disclosure functions. The position requires the ability to work collaboratively with cross-functional teams in a fast-paced environment. The qualified candidate will also have experience in management of external vendors and the development of operational process improvements such as work practice documents, SOP development and updates, and document templates. There will need to be a very strong understanding of document timelines as planning is critical.

• Provides leadership, strategy, and oversight of the Medical & Regulatory Writing team.
• Serves as subject matter expert in preparing clinical regulatory documents through all phases clinical research.
• Represent medical writing in cross-functional team meetings.
• Collaborate with department heads and staff members of cross-functional groups, including clinical research, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs as necessary to deliver documents with high quality on time.
• Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.
• Support the development, improvement and maintenance of medical writing work practice documents, SOPs, and document templates to ensure consistency and efficiency.
• Oversight of vendors including contract writers, QC reviewers, and document formatters.
• Must have proficiency in the use of EndNote or RightFind Cite It software for the citation of literature references and creation of list of references in Word documents.
• Maintain current knowledge of industry trends and best practices for medical writing
• Performs other duties as assigned

JOB SPECIFICATIONS:

• Bachelor’s, Master’s or PhD Degree in scientific, medical, clinical discipline or related field is required. Masters or Ph.D. degree is preferred.
• Strong track record of people management and delegating work.
• 12+ years of relevant industry experience as a medical writer in a pharmaceutical, biotech, or CRO environment. Oncology experience preferred.
• Must have experience authoring clinical study reports, protocols, protocol amendments, Investigator’s Brochure. Experience authoring and managing briefing books is a plus.
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Project management skills as related to medical writing.
• Ability to manage complex writing projects with minimal supervision.
• Must have the ability to edit text for brevity and clarity.
• Ability to understand, interpret and present complex clinical data.
• Must be highly detail oriented.
• Ability to coordinate multiple documents while effectively managing timelines.
• High degree of independence in decision making and problem solving.
• Leads decision-making across multiple programs or areas, setting direction and making strategic trade-offs that impact cross-functional execution and outcomes.
• Drives cross-functional alignment across multiple programs, influencing stakeholders to shape strategy and ensure cohesive execution across functions.
• Understanding of FDA and ICH regulations and guidelines.
• Familiarity with eCTD-compliant templates and with the use of document formatting tools such as ISI writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools.
• Must be an expert with MS Word and have a solid working knowledge of MS Excel, MS PowerPoint, and MS Project.
• Experience in use of an EDMS such as Documentum, Core Dossier, or Veeva.

The base range for this role at the Senior Director level is $265,000 - $306,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

#LI-RM1

Location: Boston, MA preferred

The Associate Director, Clinical Data Management (CDM) is an individual contributor and leadership role within Vor's Biometrics organization, responsible for strategic oversight and operational delivery of all clinical data management activities across Vor's clinical portfolio. This individual will serve as one of Vor's internal CDM experts leading study and program-level data governance, owning EDC architecture and data standards, managing CRO and vendor partnerships, and ensuring continuous regulatory inspection readiness. 

This role will be accountable for department-level strategy, SOP ownership, regulatory inspection representation as a named CDM subject matter expert, and cross-regional data integration from multi-national studies. The Associate Director serves as a senior escalation point and represents the CDM function at program governance forums and regulatory interactions. 

Key Responsibilities 

1. CDM Strategy & Portfolio Oversight 

• Contribute to the strategic and operational leadership for multiple CDM activities across Vor's clinical portfolio, from protocol synopsis through database lock, archiving, and regulatory submission. 

• Serve as the CDM functional lead on program teams, contributing to clinical development plans, protocol design, and study feasibility assessments from a data quality and operability perspective. 

• Define and communicate CDM strategy, standards, and milestone timelines at the study and program level; identify risks early and communicate mitigation plans to senior leadership. 

• Partner with Biostatistics and Statistical Programming to ensure seamless data flow from EDC through SDTM/ADaM datasets and downstream regulatory analyses. 

2. EDC Platform Ownership & Data Standards — Medidata Rave 

• Serve as Vor's primary subject matter expert (SME) and platform owner for Medidata Rave EDC, governing the full ecosystem: study build, library management, edit check strategy, change control, and system validation. 

• Lead development and governance of Vor's CDASH-aligned CRF standards library within Medidata Rave — ensuring consistency, reusability, version control, and regulatory/submission alignment across all programs. 

• Oversee CRF design, database build specifications, UAT strategy, and production release quality control across all active studies. 

• Ensure EDC configurations comply with CDISC CDASH/SDTM standards, facilitating optimal downstream dataset programming for regulatory submissions. 

• Evaluate and implement emerging Medidata capabilities (e.g., eConsent, eCOA integrations, Medidata AI data monitoring) to advance quality and operational efficiency. 

• Maintain governance of edit check specifications, data review guidelines, and coding conventions (MedDRA, WHODrug) across all Vor studies. 

3. Cross-Regional Data Integration & Bridging Studies 

• Lead the CDM strategy for multi-regional clinical trials, including studies with non-US-originated or non-US-concurrent data (e.g., bridging studies, ICH E17-compliant global programs). 

• Oversee data transfer, reconciliation, and harmonization from non-US regional CROs and data platforms, ensuring data integrity when integrating datasets from non-US investigational sites or partners into global submissions. 

• Partner with Regulatory Affairs and Biostatistics to define data requirements for integrated global analyses and data pooling strategies (per ICH E17) for FDA and EMA submissions. 

• Ensure regional data collection practices — including eCRF language localization, coding dictionary alignment, and site training materials — satisfy both local regulatory requirements and Vor global data standards. 

• Manage data transfer specifications and reconciliation protocols for all third-party data streams: central labs, IRT, safety databases, eCOA, and regional CRO-generated datasets. 

4. Regulatory Inspection Readiness & Direct Inspection Representation 

• Ensure Vor's CDM documentation, TMF data management sections, and EDC audit trails are maintained in a state of continuous inspection readiness throughout the study lifecycle. 

• Serve as the CDM subject matter expert and primary spokesperson in regulatory inspections (FDA, EMA, competent authority), audits, and quality reviews — directly answering inspector and auditor questions on data management practices, EDC systems, data integrity, and audit trail review. 

• Prepare CDM inspection packages including data management plans, system validation documentation, audit trail narratives, and data quality metrics for regulatory review. 

• 5. CRO & Vendor Management 

• Serve as Vor's senior CDM oversight lead for external CRO DM partners — including contract scope definition, performance governance, issue escalation authority, and quality review. 

• Establish and enforce CDM expectations, SOW deliverables, and quality metrics for all external vendors: CROs, EDC service providers, central labs, IRT vendors, and eCOA/ePRO platforms. 

• Review and approve all key DM vendor deliverables: data management plans, CRF completion guidelines, edit check specifications, data transfer agreements, and database lock packages. 

• Lead vendor qualification activities and contribute to CRO selection processes as a CDM technical evaluator. 

6. Quality, Compliance & SOP Governance 

• Develop, maintain, and continuously improve Vor's CDM SOPs, work instructions, templates, and data management plans in alignment with ICH E6(R3), FDA 21 CFR Part 11, EU Annex 11, GCDMP, and CDISC standards. 

• Ensure compliance with electronic records and electronic signatures regulations across all EDC systems and data management platforms. 

• Track and report data quality metrics, query resolution rates, cleaning milestones, and database lock timelines to program teams and leadership. 

7. Cross-Functional Collaboration 

• Collaborate closely with Biostatistics, Statistical Programming, Clinical Operations, Regulatory Affairs, Medical Writing, and Safety to ensure CDM activities support all downstream deliverables. 

• Partner with Clinical Operations on site training, data entry guidance, and site data quality monitoring. 

• Provide CDM input into clinical study reports, regulatory briefing documents, and submission-ready data packages. 

• Represent CDM on study teams, program governance boards, and senior leadership forums. 

8. Leadership & Talent Development 

• Provide mentorship, technical guidance, and professional development support to Sr. Data Managers and Data Managers within the CDM team. 

• Contribute to workforce planning and hiring, helping define and scale CDM capabilities as Vor's pipeline grows. 

• Foster a high-performance, quality-first team culture aligned with Vor's clinical mission. 

Qualifications 

Education 

• Bachelor's degree in Life Sciences, Health Informatics, Computer Science, or related field required. 

• Advanced degree (Master's or equivalent) preferred. 

• CCDM (Certified Clinical Data Manager) certification is a plus. 

Required Experience 

• Minimum 10 years of clinical data management experience in pharmaceutical, biotech, or CRO settings, with at least 3 years in a senior lead or management role. 

• Expert-level proficiency with Medidata Rave EDC — including study build, CRF design, edit check authoring, library management, UAT oversight, and production release governance. 

• Demonstrated prior experience as the named CDM representative in FDA or EMA regulatory inspections — directly answering inspector questions on data management practices, audit trails, and data integrity. 

• Hands-on experience with multi-regional clinical data management including integration of data from China-based or other non-US studies, data transfer reconciliation, and bridging study data strategies. 

• Deep knowledge of CDISC standards (CDASH, SDTM), ICH guidelines (E6, E8, E9, E17), FDA 21 CFR Part 11, EU Annex 11, and GCDMP. 

• Proven CRO and vendor oversight experience across full study lifecycles from startup through database lock and archiving. 

• Proficiency with coding dictionaries (MedDRA, WHODrug) and data review/cleaning methodologies. 

Preferred Experience 

• Background in autoimmune disease and/or rare disease is a plus.  

• Prior experience with front-line communications during regulatory inspections.  

• Prior experience building or scaling a CDM function in a lean, clinical-stage biotech environment. 

• Familiarity with eSource, decentralized trial (DCT) components, and real-time data monitoring technologies. 

• Experience with Medidata Rave Architect and/or Rave EDC Modules (eConsent, eCOA, Medidata AI). 

• Working knowledge of R/R Shiny/Posit Connect or other similar tools for data quality review, reconciliation, and dashboards is a plus.  

Skills & Competencies 

• Demonstrated ability to communicate complex data management concepts clearly and concisely — both in polished written deliverables and confident oral presentations — to diverse audiences including clinical teams, regulatory inspectors, senior leadership, and external partners. 

• Strategic thinking with the ability to anticipate downstream data quality and submission risks and take proactive, documented action. 

• Exceptional attention to detail combined with ability to manage multiple concurrent programs under tight timelines. 

• Ability to lead and influence cross-functionally without requiring direct authority over all stakeholders. 

• Comfort operating hands-on in a lean, fast-paced clinical-stage biotech alongside strategic departmental oversight. 

• Strong vendor management and project delivery track record for high-quality data packages on time. 

• Collaborative, patient-centered mindset aligned with Vor's mission. 

The salary range for the Associate Director, Clinical Data Management is expected to be between $185,000 and $210,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.

POSITION OVERVIEW:

The Vice President, Regulatory Partnerships is a senior leadership role within the end-to-end Regulatory Strategy organization, spanning preclinical, clinical, Regulatory CMC, Regulatory Operations, and Regulatory Partnerships. This role is responsible for leading and expanding strategic regulatory partnerships, with a strong emphasis on post-approval lifecycle management, driving integrated client solutions, and accelerating commercial growth.

This leader will play a pivotal role in shaping how regulatory services are delivered across the organization by connecting scientific expertise with strategic advisory and execution, while positioning the company as a trusted partner to global pharmaceutical and biotech clients. A key focus of the role will be optimizing post-approval strategies, enhancing client delivery models, driving efficiencies, and embedding continuous improvement across engagements.

KEY RESPONSIBILITIES:

Strategic Leadership and Organizational Impact

• Lead the Regulatory Partnerships function as a core component of an integrated, end-to-end Regulatory Strategy organization
• Define and execute the strategic direction for partnerships, including post-approval and lifecycle management capabilities, ensuring alignment with broader business goals
• Build, lead, and develop a high-performing global team across the United States, India, and evaluate entry into Europe
• Partner across Regulatory Consulting, Regulatory CMC, Regulatory Operations, and other service lines to deliver seamless, client-centric solutions
• Builds a culture of rigor and accountability by establishing clear performance metrics, KPIs, and standardized processes across regulatory partnerships, enabling consistent measurement of delivery quality, efficiency, and client outcomes.

Commercial and Business Acumen

• Drive revenue growth through expansion of strategic client partnerships and development of new business opportunities, including post-approval lifecycle services
• Act as a commercial leader, contributing to pipeline development, account strategy, and revenue forecasting, in consultation with the Commercial team
• Collaborate with Commercial and Business Development teams to shape go-to-market strategies and differentiated service offerings
• Identify opportunities to expand client engagements through lifecycle management, regulatory optimization, and long-term partnership models
• Monitor industry trends, competitive landscape, and evolving regulatory requirements to inform growth strategy

Client Leadership and Partnership Excellence

• Serve as an executive sponsor for key global client relationships
• Lead and manage strategic client partnerships with a focus on long-term lifecycle support, including post-approval activities (variations, supplements, global submissions)
• Build and sustain value-driven relationships with senior client stakeholders across regions
• Ensure consistent, high-quality delivery across engagements, with a focus on scalability, predictability, and client satisfaction
• Leverage client insights and engagement learnings to continuously refine delivery models and strengthen partnerships

Operational Excellence, Efficiencies, and Continuous Improvement

• Drive operational efficiencies by standardizing processes, tools, and delivery models across regulatory partnerships
• Capture and implement learnings from client engagements to enhance quality, consistency, and speed of delivery
• Establish best practices for global post-approval lifecycle management and submission strategies
• Partner with internal teams to optimize resource models, utilization, and delivery effectiveness
• Embed a culture of continuous improvement, innovation, and knowledge sharing
• Leverages data and insights to drive decision-making, continuously refine delivery models, and ensure transparency and alignment across global teams.

Technical and Functional Expertise

• Provide deep expertise across global regulatory frameworks, including FDA, EMA, and other international health authorities, with a strong focus on post-approval requirements
• Guide teams on complex regulatory strategies across the full product lifecycle
• Maintain oversight of quality, compliance, and consistency across all client deliverables
• Contribute to thought leadership, innovation, and advancement of regulatory strategy capabilities

Global Leadership and Cultural Agility

• Lead and develop globally distributed teams, with direct experience across the United States, India, and Europe
• Demonstrate strong cultural awareness and adaptability, enabling effective collaboration across diverse teams and client environments
• Navigate the complexities of global client delivery, recognizing that client partnerships span multiple regions, regulatory bodies, and cultural contexts
• Align global teams to shared goals while respecting regional differences in communication, decision-making, and execution
• Evaluate and, if needed, support expansion into European markets, with an understanding of regional regulatory dynamics and business opportunities
• Foster an inclusive, high-performance culture that promotes accountability, engagement, and excellence across geographies

QUALIFICATIONS & EXPERIENCE:

Education

• Bachelor’s or Master’s degree in Biology, Chemistry, or a related scientific field required

Experience

• 15+ years of progressive experience in Regulatory Affairs, including significant experience in post-approval and lifecycle management
• Demonstrated experience working with the U.S. Food and Drug Administration and strong knowledge of European regulatory frameworks
• Proven experience working within both large pharmaceutical organizations and scientific consulting environments
• Track record of leading and scaling global teams across the United States, India, and Europe
• Strong commercial acumen with demonstrated success in driving revenue growth and expanding client accounts
• Experience leading complex global client engagements and managing senior stakeholder relationships
• Demonstrated ability to drive operational efficiencies, standardization, and continuous improvement
• Experience supporting or leading global regulatory partnership models or FSP-style engagements preferred

Leadership Profile

• Strategic, enterprise thinker with the ability to connect regulatory expertise to business growth
• Commercially driven with strong business and financial acumen
• Client-focused leader who builds trusted advisor relationships
• Collaborative operator who thrives in a matrixed, global organization
• Proven people leader with the ability to develop, inspire, and retain high-performing teams
• Highly adaptable, with strong executive presence and ability to influence across all levels of the organization

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

Your impact:

High visibility role as DSPV Operations Lead, will play a critical, strategic and hands-on operational role in supporting PV across all clinical development programs.  

Your day-to-day:  

Clinical Trial Support

• Lead the process for Individual Case Safety Report (ICSR) collection, processing, reconciliation, submission and distribution ensuing compliance with regulatory timelines and global regulations and guidelines
• Oversee reconciliation activities between the safety and clinical databases, as well as business partner safety data exchange
• Identify and support the development of Safety Management Plans (SMPs), and other study specific project plans
• Work closely with Data Management of EDC development for the purposes of safety data collection including Annotated CRF reviews and associated activities.
• Collaborate with DSPV Safety Science and Data Management to prepare safety data listings and reports as needed and to participate in QC related to safety data for various reports and deliverables
• Collaborate cross-functionally with Regulatory Affairs, Clinical Operations, Clinical Development, Data Management, Quality Assurance, and other relevant teams to ensure appropriate PV processes are in place and adhered to
• Prepare and deliver training on SAE reporting processes and practices at Investigator Meetings, to CRAs, to CROs, sites, as applicable.
• Lead DSPV Trial Master File document review, QC and provision to study specific TMFs
• Support DSUR preparation by maintaining DLP and submission calendar, supporting Kick-Off Meeting activities, requests for and attainment of information from cross-functional teams
• Assist with DSPV Operational processes and initiatives, representing PV Operations in collaboration with other functions as needed.

Vendor Management

• Lead day-to-day operational oversight of pharmacovigilance service provider
• Establish and/or maintain oversight of key performance indicators (KPIs), key risk indicators (KRIs), key quality indicators (KQIs), and routine operational reports
• Drive continuous improvement initiatives to enhance the efficiency and effectiveness of PSPV quality activities, and functional goals
• Obtain close oversight of ICSR quality including performance of QC as needed
• Oversee safety database configuration updates, system updates, maintenance, E2B gateway implementations, user account management, back-up testing, and other activities as required
• Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, deviations related to case management processes, as defined in the SMPs or SOPs, and PVA compliance

Quality and Compliance

• Support the development, review, and maintenance of Standard Operating Procedures (SOPs) / Work Instructions (WIs) for DSPV.
• Support PV audit and inspection activities, as required, and serve as SME for DSPV Operations during these activities
• Ensure DSPV processes and systems comply with global regulatory guidelines, company policies, industry best practices, and PVAs.
• Maintain a comprehensive DSPV Quality Management System aligned with DSPV functional goals
• Prepare and present DSPV Compliance Reports to DSPV/QA forum, highlighting trends, issues, and opportunities for improvement

Must-Haves:

• Degree in Life Sciences, Pharmacy, Nursing or related field
• 8+ years of experience in PV in Biotech, Pharma, or a CRO
• 5 years of experience working with and providing oversight to PV vendors and/or hosting partners.
• Experience in preparation and review of data outputs for aggregate safety report generation (i.e., DSUR, PBRER).
• Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance.
• Effective collaboration and interpersonal skills.
• Ability to work independently, establish work priorities, and execute decisions with minimal guidance
• Excellent decision-making and analytical skills.

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $170,000 to $185,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

About the Role >>> Sr Director, Commercial Manufacturing & Operations

As the Sr Director, Commercial Manufacturing & Operations reporting to the SVP of CMC & Supply Chain, you will be an experienced manager with a track record of successful project leadership and oversight of late-stage (registrational, process validation, commercial) manufacturing of small molecule drug substances and drug products. You will be responsible for the execution of technical transfer (including process validation activities), oversight of manufacturing activities, document review, quality event support, etc. for drug substances and drug product.

This role is based out of our Boston, USA and will require 20% travel.

Your work will primarily encompass:

· Support the US launch of palazestrant in 2027 by creating the commercial supply platform and strategy

· Establish an operational commercial mapping of supply and partners (state licenses, 3PL & order-to-cash Services, shipping and import/export logistics, import/export compliance)

· Provide technical and functional project leadership on drug substance (DS) and drug product (DP) commercial manufacturing, and CMO management

· Develop business processes and systems to support and streamline all DS and DP commercial activities. Work globally to implement processes and systems within Olema’s global CDMO network. Develop metrics and continuous improvement initiatives.

· Ensure employees are engaged and tied to the global Olema’s business strategy

· Lead or manage documentation review and approval (MBRs, specifications, analytical methods, etc.), change controls and documentation for internal batch disposition

· Oversee investigations related to deviations to assess impact to product and manufacturing process; ensures timely closure of such investigations

· Partner with Commercial, Quality Assurance and CMC Regulatory Affairs SMEs to develop and operate appropriate commercial procedures to ensure the drug substance and drug product meets established quality standards and adheres to established and regulatory agency approved parameters

· Work closely with SMEs and CMOs to execute shipment of drug substance batches and drug product lots

· Partner with supply chain teams to design DS and DP production schedules while maximizing production and cost efficiencies

· Develop, maintain and communicate product manufacturing plans, timelines, milestones and budgets. Integrate and align commercial manufacturing activities with corporate development program objectives. Develop and apply resource and capacity models

· Stay current with state-of-the art approaches and applicable global regulations and industry standards

Ideal Candidate Profile >>>

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge and experience:

· BS/MS/Ph.D. in Chemistry, or related discipline with a minimum of 10+ years of experience, or a business degree with a minimum of 15 years of experience, in a CMC development and manufacturing organization

· Sense of urgency, ability to recognize time sensitivity, appetite to lead aggressive activity within the manufacturing function

· Flexible and adaptable style, achievement oriented by nature with a willingness and eagerness to take on challenges

· Visionary as well as tactile and concrete at an operational level.

· Demonstrated successful leadership in a pharmaceutical CMC drug substance and drug product development and manufacturing role

· Broad experience working with CDMOs and managing external development and manufacturing partners

· Expertise in oversight of GMP manufacturing, including tech transfer and process validation

· Understanding of supplier performance management (quality metrics, adherence to supply and quality agreements) and familiarity with commercial supply agreement negotiations

· Thorough understanding of global regulatory requirements for the manufacture, testing, and control of commercial drug substances

· Strong communication, negotiation, problem solving and decision-making skills at all levels of the organization, verbally and in writing

· Ability to work collaboratively to connect vision, strategy and goals and present plans, justifications and mitigation scenarios to executive management

· Effective written, oral communication and interpersonal skills

Attributes:

· A high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally. Strong initiative and follow-through are essential for this job.

· Specific personal characteristics include:

o Highly analytical and detail oriented

o Self-Starter

o Goal and data driven

o Ability to multi-task and shift priorities rapidly to meet tight deadlines

o Aspires to the highest scientific and ethical standards

o Keen to improve processes and overcome inefficiencies

The base pay range for this position is expected to be $225,000 - $250,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MK1

#LI-MK1

RC Resolve is a strategic communications advisory firm working at the intersection of finance, corporate reputation, public affairs, and brand for healthcare companies, backed by the capabilities and expertise of Real Chemistry.  

We partner with boards and management teams during normal course and transformative periods to design communications strategies that help companies advance business goals, build trust, and seize timely market opportunities. We counsel executives and boards through highstakes moments including M&A, IPOs, restructurings, shareholder activism, crises, and major corporate transformations. 

We are seeking a senior leader to build and lead our Financial and Transaction Communications offering, working with clients across sectors and geographies. 

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

Role Overview 

The Head of Financial and Transaction Communications will be a senior leader responsible for: 

• Building and leading our financial communications practice 

• Serving as a primary advisor to CEOs, CFOs, General Counsel, Heads of IR, and Boards working in concert with their key advisors 

• Driving new business and deepening relationships with existing clients to support issues and opportunities  

• Leading teams through complex, high-stakes, timesensitive, and confidential situations 

This role suits an experienced financial communications professional from a top-tier advisory firm, inhouse IR/corporate comms team, or similar environment, who thrives in fastpaced, transaction driven work and business- and relationship-building opportunities. 

Key Responsibilities 

Client Advisory & Strategy 

• Serve as trusted counselor to senior executives on all aspects of financial and capital markets communications. 

• Develop and oversee integrated communications strategies around:

• IR Advisory
• M&A
• IPOs and SPACs
• Activist Defense & Preparedness
• Restructuring
• Bankruptcy
• Executive Transitions
• Divestitures & Spins
• Investor and R&D Days
• Financial Media Relations & Storytelling

• Craft clear, compelling narratives that translate complex financial and strategic issues for investors, media, employees, regulators, and other stakeholders. 

• Provide real-time strategic counsel in high pressure, confidential situations, often in partnership with legal and banking advisors. 

Transaction/Event-driven Communications 

• Lead communications workstreams for event-driven situations (to include but not limited to: M&A, IPOs/Spins/SPACs, activism, bankruptcies/restructurings, crisis (cyber, litigation and beyond), Board/management transitions.), including: 

• Prospecting, relationship building with key advisors (bankers, lawyers, etc.) focused on HC sector. 

• Leading transaction / event-driven work. 

• Development of comms strategy, materials, media and social considerations. Support of the lead up to announcement, announcement day as well as integration support. 

• Deal playbook and scenario planning to protect and preserve reputation and valuation throughout the deal process 

• Development of strategy, scenario planning, communications playbook, etc. for lead up to, day of and post-announcement situation  

• Drafting key materials (press releases, Q&As, investor decks, fact sheets, talking points, etc.) 

• Coordinating with key advisors (lawyers, bankers, etc.) and ensure alignment with regulatory and disclosure requirements 

IR Advisory & Related Services 

• Develop and refine clients’ equity story/investor narrative 

• Oversee creation and quality of investor facing collateral, including: 

• Investor presentations 

• Investor day/R&D day materials  

• Infographics 

• IR website alignment with collateral 

• Earnings Advisory: Advise and support the development of earnings materials: to include press release, deck, scripts, Q&A prep  

• Advise on engagement with sellside and buyside analysts in coordination with IR and legal teams. 

• Annual reports as well as sustainability reports (in partnership with design/ESG teams as needed). 

• Advise on integration of financial communications with broader corporate reputation, ESG, and public affairs strategies. 

Financial Media & Stakeholder Engagement 

• Lead financial and business media strategy, cultivating relationships with key journalists and outlets. 

• Prepare executives for highstakes media interviews, investor meetings, earnings calls, and roadshows. 

Practice & People Leadership 

• Build and lead a high-performing financial communications team within the agency, including integration of legacy IR team, recruitment, training, and mentorship. 

• Set practice standards, playbooks, and bestinclass approaches for transaction and capital markets mandates. 

• Foster collaboration across practices (corporate, crisis, public affairs, digital, ESG, brand) to deliver integrated solutions. 

• Contribute to firm leadership, culture, and DEI objectives. 

Business Development 

• Drive growth of the financial communications practice through: 

• Identifying and pursuing new business opportunities 

• Leading and contributing to pitch development and presentations across significant client base 

• Build rapport and become a trusted, go-to referral partner for network among corporates, private equity, banks, law firms, and other advisors. 

• Help shape the agency’s market profile via thought leadership (reports, opeds, conferences, webinars) on capital markets, M&A, activism, and related themes. 

Qualifications 

• 15+ years of experience in financial communications, investor relations, investment banking, equity research, or related fields, with a strong advisory component. 

• Proven track record working on complex, highstakes situations such as: 

• M&A (including crossborder, contested, and private equitybacked deals) 
• IPOs and significant capital markets transactions 
• Shareholder activism and governance/ESG-related campaigns 
• Restructurings, turnarounds, and crisis situations with market impact. 
• Experience in a leading strategic communications/PR firm (e.g., financial/transaction communications practice) or top-tier in-house corporate role strongly preferred.  

• Experience working with healthcare clients a plus      

Skills & Capabilities 

• Deep understanding of capital markets and the needs of institutional investors and analysts. 

• Exceptional writing skills: capable of producing clear, concise, and persuasive materials under tight deadlines. 

• Strong judgment and discretion, with demonstrated ability to advise senior executives and boards in sensitive situations. 

• Comfortable operating in fast-paced, ambiguous, and time pressured environments; calm and solutions-oriented under stress. 

• Strong project and team management skills; able to run multiple complex engagements simultaneously. 

• Collaborative and low ego; able to integrate with cross-functional teams including legal, banking, IR, public affairs, digital, and creative. 

Education & Other 

• Bachelor’s degree required; advanced degree (MBA, JD, or related) a plus but not required. 

• Understanding of US regulatory and disclosure frameworks; global regulatory expertise not required but helpful 

• Willingness to work extended hours during live situations and to travel as required. 

  Pay Range: $300,000 - $360,000

  This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time

POSITION OVERVIEW

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research

The Medical Director is a leader of the Science37 clinical team. Working within the department of Medical Affairs, this individual is responsible for a broad range of activities across several core functions. We are seeking an energetic physician to help drive innovation in the clinical research ecosystem​​.  This is a full-time, remote position and the individual chosen to fulfill this role can work from home. 

DUTIES AND RESPONSIBILITIES

Duties include but are not limited to:

Science 37 studies

• Function as the Principal Investigator for clinical trials when Science 37 is executing studies as either a Direct to Patient Site or fully decentralized trial
• Function as a Sub-Investigator for clinical trials for therapeutic areas/ indications that align with clinical expertise/ experience when Science 37 is executing studies.
• Coordination with Site Operations Manager to identify, onboard and train investigators for Science 37 studies
• Educate and train Science 37 study team about target patient population and treatment paradigms for given indication for Science 37 studies

Support for Science 37 Commercial Team

• Collaboration with Business Development counterpart to review study opportunity synopses/protocols to assess fit/feasibility for decentralized trial model 
• Support Business Development counterpart during sponsor/client meetings and teleconferences
• Support Science 37 study opportunities as a subject matter expert in the development of study opportunity proposals

Regulatory Engagement

• Collaborate with Science 37 Regulatory Affairs team to engage the FDA and other global regulatory bodies regarding the decentralized trial model, and its acceptance for global studies
• Work with sponsors/collaborators to identify clinical endpoints that are fit for decentralized clinical trial conduct
• Collaborate with sponsors and regulatory bodies to migrate endpoints from clinic-based conduct and validate their use for in-home conduct 

Thought Leadership

• Serve as Science 37 representative for decentralized clinical trial and therapeutic area-specific expertise at industry/clinical conferences and webinars
• Publish peer-reviewed articles and white papers related to therapeutic area-specific expertise and the decentralized clinical trial model

QUALIFICATIONS & SKILLS

Qualifications 

1. Advanced degree in Medicine (MD or equivalent)
2. Board-certification in Med/Peds or Pediatrics
3. 7+ years of demonstrating clinical & research excellence within academia and/or pharma
4. Experience as a Principal Investigator with a focus on pharmaceutical-sponsored studies

Skills/Competencies

1. Expertise in project management - Demonstrates ability to successfully lead/manage research personnel. Proactive problem-solving abilities and follow through.
2. Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decision-making.
3. Extensive knowledge of clinical research - Understands the drug development process. Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to create and review protocols, programs, and assess the feasibility/pathway to success of a project.
4. Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive sponsor, project team members and internal Science37 relationships. Ability to conduct effective presentations.
5. Computer skills - Working knowledge of MS Office suite and Google applications. Able to generate business correspondence, create forms and generate reports as required. 
6. Practices professionalism and integrity in all actions – Demonstrates ability to foster concepts of teamwork, cooperation, responsibility, and flexibility to get the work done.
7. Other – Ability to communicate in English (both verbal and written).
8. Preferred knowledge of Spanish

REPORTING

• Position Reports to the Chief Medical Officer

Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. 

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.

Submit your resume to apply!

Role Overview 

We are seeking highly skilled, and motivated Director of Combination Product & Device Development, to lead the development, manufacturing, assembly and commercialization of high‑concentration biologic delivery systems, including, prefilled syringes, autoinjectors and other drug–device combination products.

The ideal candidate brings deep expertise in device design control, verification and validation, risk management, combination product regulations, and human factors engineering. This role requires hands‑on technical leadership and extensive experience with regulated devices and combination products (21 CFR 820, ISO 13485), as well as strong knowledge of global device standards (ISO, IEC 62366, ANSI/AAMI HE75) and FDA guidance. A successful track record supporting major regulatory submissions (BLA, MAA, IND/IMPD) and notified body assessments is essential.

Key Responsibilities 

Device Development

• Lead end‑to‑end development and commercialization of prefilled syringes, dual‑chamber cartridges, autoinjectors, and related combination product systems.
• Serve as a hands‑on technical leader and device SME across concept, feasibility, development, qualification, and launch phases.
• Define user needs and product requirements; lead prototyping, test method development, and design verification and validation (DV/V) activities.
• Drive design control documentation, risk assessments, usability studies, and human factors integration.
• Collaborate deeply with internal partners across CMC, drug product development, quality assurance, regulatory affairs, clinical development, supply chain, and commercial functions.
• Build and manage external relationships with CDMOs, device manufacturers, design firms, and suppliers to support development and lifecycle needs.
• Support lifecycle management of commercial combination products, including design history file (DHF) maintenance, change control, validation activities, complaint investigations, and post‑market surveillance.
• Evaluate technical decisions for cross‑functional impact and implement contingency plans as needed.
• Proactively identify and address manufacturing issues; coordinate technical solutions across internal and external teams.
• Lead creation of design control deliverables to ensure compliance with global device and combination product regulations.
• Oversee development of statistically sound verification protocols, reports, and design validation strategies.
• Lead or contribute to investigations of deviations, failures, complaints, and device‑related quality issues.

Design Controls & Human Factors

• Serve as the organizational expert in Human Factors Engineering, ensuring compliance with IEC 62366, ANSI/AAMI HE75, FDA guidance, and related industry standards.
• Integrate usability, human performance considerations, and safety risk mitigations into system requirements and development strategies.
• Ensure all human factors processes, deliverables, and standards are appropriately documented within the Design Control Quality System.
• Lead the cross‑functional design control sub‑team and drive cohesive integration across device design, analytical testing, packaging, manufacturing, clinical, supply chain, commercial, and regulatory functions.
• Manage and prioritize multiple concurrent projects, ensuring alignment to scope, timelines, budgets, and quality standards.

Regulatory Support

• Ensure compliance with global combination product and medical device regulations, including FDA and EU frameworks (e.g., EDDO, MDR).
• Author device‑related sections for regulatory submissions (BLA, MAA, IND/IMPD) and support notified body interactions.
• Represent the combination product function during regulatory audits and inspections.
• Lead proactive risk identification, mitigation planning, and escalation of critical issues.
• Demonstrate strong understanding of FDA’s Office of Combination Products (OCP), including primary mode of action (PMOA) requirements and combination product complaint expectations.

Qualifications 

• Master’s degree (or equivalent) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related field.
• 15+ years of experience in biologic delivery device development with a proven record of supporting late‑stage development and commercial product launches.

• Experience with design controls, device risk management, medical devices, prefilled syringes, autoinjectors, and related scientific and technical concepts and techniques is required for this position.
• Deep knowledge of subcutaneous delivery systems, systems engineering principles, device materials, and manufacturing technologies; experience with biologics and packaging development preferred.
• Strong understanding of FDA and EU regulations for medical devices and combination products, including relevant quality systems and standards.
• Experience managing external partners, vendors, and contract manufacturers.
• Proven experience with cGMP process development, manufacturing controls, and process risk assessments.
• Excellent communication, leadership, and cross‑functional collaboration skills.
• Ability to thrive in a fast‑paced, agile environment; start‑up experience is highly desirable.

Position Location 

This is a fully remote role with up to 15-20% domestic and/or international travel.

The anticipated salary range for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

ESSENTIAL JOB FUNCTIONS:

The Senior Director of Pharmacovigilance (PV), Safety Sciences & Surveillance, provides strategic and operational leadership for global safety surveillance activities across Kura’s clinical and post-marketing programs. This individual is responsible for signal detection and evaluation, benefit-risk assessment, and safety surveillance strategies, for the company’s products. This role ensures compliance with global pharmacovigilance regulations and drives proactive risk management to protect patients and support product development.

This position partners cross-functionally with Clinical Development, Nonclinical, Regulatory Affairs, Biostatistics, and Quality to ensure robust safety oversight throughout the product lifecycle

Strategic Leadership

• Lead the Safety Sciences/Surveillance function, setting strategies for signal detection, risk management, and aggregate safety reporting.
• Lead safety strategy contributions to regulatory submissions, and lifecycle management strategies.
• Serve as safety lead on cross-functional governance committees (e.g., Safety Monitoring Committees).

Safety Surveillance & Signal Management

• Drive the development and continuous evolution of safety signal detection methodologies and product-specific signaling strategies. 
• Lead signal validation, prioritization, and assessment processes in alignment with global regulations; interpretation of safety signals and trends; communication of safety assessments (written and verbal) of safety risks in collaboration with other functional stakeholders.

Risk Management & Regulatory Strategy

• Provide strategic oversight for Risk Management Plans (RMPs), REMS (if applicable), and other risk minimization activities.
• Serve as safety representative in interactions with global regulatory authorities.
• Ensure inspection readiness and support health authority audits/inspections.

Aggregate Reporting & Safety Communications

• Oversee preparation and review of aggregate safety reports (DSURs, PSURs/PBRERs, aggregate reports for anticipated events).
• Ensure alignment of safety messaging across clinical, regulatory, and medical communications.
• Provide strategic direction of safety content for key regulatory documents (e.g., DSURs, PSURs, IBs, protocols, RMPs) ensuring consistency and scientific rigor.

Cross-Functional Collaboration

• Partner with Clinical Development on safety monitoring strategies and DMC interactions.
• Collaborate with Biostatistics on integrated safety analyses.
• Provide safety expertise to Medical Affairs and Commercial teams for post-marketing surveillance, as needed.

Compliance & Quality

• Maintain oversight of safety vendors and CROs supporting surveillance activities.
• Contribute to SOP development and continuous improvement of PV systems and processes.
• Support inspection readiness activities, internal audits and external inspections.

Team Leadership

• Mentor and develop a high-performing Safety Sciences team.
• Foster a culture of scientific rigor, accountability, and patient focus.
• Manage departmental budget and resource planning.

JOB SPECIFICATIONS:

• PharmD or PhD in life sciences preferred.
• Advanced clinical or regulatory training highly desirable.
• 12+ years of experience in pharmacovigilance or drug safety.
• 5+ years in leadership roles within Safety Sciences, Signal Detection, or Safety Surveillance.
• Experience supporting global regulatory submissions and health authority interactions preferred.
• Strong background in oncology required.
• Experience in both clinical development and post-marketing safety preferred.
• Strong knowledge of signal detection methodologies and benefit-risk assessment.
• Experience in the principles and techniques of data analysis, proficient in the use of data analysis/visualization software.
• Working knowledge of industry standard safety databases, Regulatory databases, and other electronic data capture systems; working knowledge of MedDRA and WHODrug dictionaries.
• Proven experience authoring and reviewing aggregate safety reports.
• Demonstrate a deep understanding of and ensure compliance with current global PV regulations (FDA, EMA, CIOMS, ICH E2 guidelines).
• Strategic thinker, a self-starter with strong scientific judgment.
• Executive presence and ability to influence cross-functional stakeholders.
• Excellent written and verbal communication skills.

The base range for a Senior Director is $274,000 - $330,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

#LI-RM1

Your Impact:

Rapport is seeking an Associate Director / Director of Biostatistics who will have a hands-on role in shaping the design, analysis, and interpretation of clinical trial data for our precision neuromedicine programs. Reporting to the Head of Biostatistics, you will collaborate closely with multidisciplinary teams to advance groundbreaking therapies, ensuring statistical rigor and the highest standards of data integrity throughout the drug development process.

Your Day-to-Day:

• Working as a leading statistician on multiple studies/projects. Oversee the production of protocol development (study design, endpoint selection, sample size calculation and statistical methods) and Statistical Analysis Plan (SAP) that lead to comprehensive clinical study reports suitable for regulatory submissions.
• Leads collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enables successful impact on robust drug development plans
• Support statistical programming to plan, execute and deliver SDTM and ADaM datasets, tables, listings, and figures (TLFs). Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH, FDA, EMA).
• Provide statistical input and the interpretation of results to clinical study reports, regulatory submissions documents, and publications, in collaboration with the clinical, regulatory, and medical affairs teams.
• Perform and validate statistical analyses of clinical trial data using SAS and/or R in accordance with regulatory and internal standards.
• Participate in the development and review of case report forms (CRFs) and data management plans to ensure accurate data collection aligned with study objectives.
• Oversee and manager external CROs and vendors to ensure high-quality and timely deliverables.
• Participate in cross-functional team meetings, providing statistical support and insights to influence decision-making.

Must-Haves:

• Associate Director: PhD with 6+ years or MS with 9+ years of biostatistics experience
  • Director: PhD with 9+ years or MS with 12+ years of biostatistics experience
• CNS therapeutic area experience is a plus
• Skilled in scientific programming including SAS or R, or Python for data analysis, graphing, and simulation
• Comprehensive knowledge of clinical trial design, advanced statistical analysis methods, and familiarity with regulatory guidelines (FDA, EMA, ICH)
• Extensive knowledge with CDISC standards (SDTM, ADaM) and industry best practices for data collection, analysis, and reporting
• Ability to communicate complex statistical concepts clearly to non-statistical audiences.
• Ability to manage multiple projects in a fast-paced environment, flexibility to adapt to changing priorities and timelines
• Ability to effectively collaborate with internal stakeholders and manage the statistical work of external stakeholders/vendors

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $190,000-$220,000 for the Associate Director level and $230,000-$250,000 for the Director level. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

This role has the ability to be fully remote. If you are located in the Boston area, we prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office on Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

About the Role >>> Lead Senior Medical Writer 

As the Lead Senior Medical Writer, reporting to the Director of Medical Writing, you will lead the development, and delivery of high-quality scientific and regulatory documents supporting Olema’s oncology portfolio. This role requires strong cross-functional leadership, partnering closely with Clinical Science, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders to translate complex clinical and preclinical data into clear, accurate, and compelling content for regulatory submissions, medical communications, and scientific publications. In addition, you will drive consistency, quality, and timelines across deliverables, contributing to the overall medical writing strategy and supporting key regulatory and clinical milestones. 

This role is based out of our Boston, MA or San Francisco, CA office and will require 10-15% travel. 

Your work will primarily encompass: 

• Preparing and editing a wide range of scientific and medical writing deliverables, including but not limited to protocols, protocol amendments, clinical study protocols, investigator brochures, regulatory submission documents (e.g. IBs, DSURs, sections of IND/IMPD/MAAs), PowerPoint presentations related to the Medical Writing function
• Collaborating with internal stakeholders (clinical scientists, regulatory strategy, medical monitors, biometrics, medical affairs) to understand data, interpret results, and ensure accurate message conveyance
• Ensuring documents adhere to internal style guidelines, regulatory requirements (e.g., ICH, GPP), and appropriate therapeutic-area standards (e.g., oncology, breast cancer)
• Maintaining version control, track author/reviewer feedback, and delivering documents according to project timelines
• Providing  writing and/or QC editing support for associated submission documents (as applicable) to help elevate overall team deliverables
• Remaining current on therapeutic area (breast cancer / endocrine-driven tumors) trends, journal publications, and regulatory guidance relevant to oncology and women’s cancers

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree (MS/PharmD/PhD) preferred
• Demonstrated and excellent scientific writing and editing skills — the ability to translate complex scientific data into clear, concise, accurate documents for varied audiences (regulatory agencies, KOLs, internal stakeholders)
• Familiarity with regulatory writing standards (e.g., ICH E3/E6, GPP)
• Oncology preferred 
• Veeva RIM experience is a plus 

Experience: 

• Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer) preferred, or a closely related therapeutic area
• Strong project management skills: able to manage multiple deliverables, meet deadlines, handle feedback iterations, and coordinate with cross-functional teams
• Ability to work independently with minimal supervision, while also being a collaborative team player
• Detail-oriented, organized, with strong verbal communication skills
• Proficiency with standard technical and document-management tools (e.g., Microsoft Word, PowerPoint, Microsoft Excel, Smartsheet, Starting Point Templates, Veeva RIM)
• Prior experience in clinical-trial documentation for oncology (eg, IBs, protocols, DSUR and CSRs) preferred
• Experience working in hybrid/remote environments

Attributes: 

• Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
• Self-motivated and enthusiastic; fast learner who can identify project challenges and expeditiously change course as required in a fast-paced organization
• Strong communicator who can tailor messaging to diverse audiences
• Highly organized with strong attention to detail and follow-through
• Ability in building strong cross functional working relationships 

The base pay range for this position is expected to be $160,000-$175,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MT1

About the Role >>> Lead Senior Medical Writer

As the Lead Senior Medical Writer, reporting to the Director of Medical Writing, you will lead the development, and delivery of high-quality scientific and regulatory documents supporting Olema’s oncology portfolio. This role requires strong cross-functional leadership, partnering closely with Clinical Science, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders to translate complex clinical and preclinical data into clear, accurate, and compelling content for regulatory submissions, medical communications, and scientific publications. In addition, you will drive consistency, quality, and timelines across deliverables, contributing to the overall medical writing strategy and supporting key regulatory and clinical milestones. 

This role is based out of our Boston, MA or San Francisco, CA office and will require 10-15% travel. 

Your work will primarily encompass: 

• Preparing and editing a wide range of scientific and medical writing deliverables, including but not limited to protocols, protocol amendments, clinical study protocols, investigator brochures, regulatory submission documents (e.g. IBs, DSURs, sections of IND/IMPD/MAAs), PowerPoint presentations related to the Medical Writing function
• Collaborating with internal stakeholders (clinical scientists, regulatory strategy, medical monitors, biometrics, medical affairs) to understand data, interpret results, and ensure accurate message conveyance
• Ensuring documents adhere to internal style guidelines, regulatory requirements (e.g., ICH, GPP), and appropriate therapeutic-area standards (e.g., oncology, breast cancer)
• Maintaining version control, track author/reviewer feedback, and delivering documents according to project timelines
• Providing  writing and/or QC editing support for associated submission documents (as applicable) to help elevate overall team deliverables
• Remaining current on therapeutic area (breast cancer / endocrine-driven tumors) trends, journal publications, and regulatory guidance relevant to oncology and women’s cancers

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree (MS/PharmD/PhD) preferred
• Demonstrated and excellent scientific writing and editing skills — the ability to translate complex scientific data into clear, concise, accurate documents for varied audiences (regulatory agencies, KOLs, internal stakeholders)
• Familiarity with regulatory writing standards (e.g., ICH E3/E6, GPP)
• Oncology preferred 
• Veeva RIM experience is a plus 

Experience: 

• Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer) preferred, or a closely related therapeutic area
• Strong project management skills: able to manage multiple deliverables, meet deadlines, handle feedback iterations, and coordinate with cross-functional teams
• Ability to work independently with minimal supervision, while also being a collaborative team player
• Detail-oriented, organized, with strong verbal communication skills
• Proficiency with standard technical and document-management tools (e.g., Microsoft Word, PowerPoint, Microsoft Excel, Smartsheet, Starting Point Templates, Veeva RIM)
• Prior experience in clinical-trial documentation for oncology (eg, IBs, protocols, DSUR and CSRs) preferred
• Experience working in hybrid/remote environments

Attributes: 

• Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
• Self-motivated and enthusiastic; fast learner who can identify project challenges and expeditiously change course as required in a fast-paced organization
• Strong communicator who can tailor messaging to diverse audiences
• Highly organized with strong attention to detail and follow-through
• Ability in building strong cross functional working relationships 

The base pay range for this position is expected to be $160,000-$175,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MT1

About the Role >>> Associate Director, Global Regulatory Strategy - International 

As Associate Director, Global Regulatory Strategy / International Regulatory Affairs, reporting to the Senior Director of Regulatory Affairs Strategy, you will contribute to the development and execution of regulatory strategies for Olema’s products in early to late-stage clinical development. You will represent Regulatory Affairs on cross-functional teams, lead the planning and preparation of clinical trial submissions (INDs, CTAs, amendments, briefing documents, Investigator Brochures) and support global health authority interactions.  

This role can be based out of our Boston, MA or San Francisco, CA office and will require domestic and international travel, approximately 10–15%

Your Work Will Primarily Encompass: 

• With limited supervision, support the development and execution of global regulatory strategies for products in Olema’s pipeline, with a focus on early development and clinical trial applications
• Serve as the Regulatory Affairs representative on global project teams and Study Execution Teams, providing regulatory input and ensuring alignment with program objectives and timelines
• Prepare and coordinate high-quality regulatory global submissions, including INDs, CTAs, amendments, annual reports, DSURs, Investigator Brochures, and briefing documents
• Under the supervision of the Senior Director, Regulatory Affairs, contribute to planning and execution of regulatory interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages, and follow-up correspondence
• Monitor the global regulatory landscape to identify requirements, trends, and potential impact on Olema’s development programs
• Coordinate and maintain health authority reporting schedules in collaboration with cross-functional teams
• Partner with external vendors (e.g., CROs, regulatory consultants) to ensure high-quality and timely submissions
• Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency
• Assist in risk assessment and mitigation planning for regulatory deliverables

Ideal Candidate Profile  

We are looking for a collaborative and driven Regulatory Affairs professional who thrives in a fast-paced environment and brings expertise in regulatory strategy

Knowledge: 

Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred

Experience: 

• Minimum 10 years of related experience with a Bachelor’s degree; or 7 years and a Master’s degree; or a PhD with 5 years experience; regulatory affairs experience in the pharmaceutical or biotechnology industry
• Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence 
• Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines)
• Oncology therapeutic area experience preferred
• Experience collaborating in cross-functional, matrixed teams 
• Experience working withCROs and other partners

Attributes: 

• Strong organizational, project management, and problem-solving skills
• Excellent oral, written, and presentation skills
• Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities
• Self-starter with the ability to work both independently and within teams

The base pay range for this position is expected to be $176,000 - $188,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MK1

About the Role >>> Associate Director, Global Regulatory Strategy - International 

As Associate Director, Global Regulatory Strategy / International Regulatory Affairs, reporting to the Senior Director of Regulatory Affairs Strategy, you will contribute to the development and execution of regulatory strategies for Olema’s products in early to late-stage clinical development. You will represent Regulatory Affairs on cross-functional teams, lead the planning and preparation of clinical trial submissions (INDs, CTAs, amendments, briefing documents, Investigator Brochures) and support global health authority interactions.  

This role can be based out of our Boston, MA or San Francisco, CA office and will require domestic and international travel, approximately 10–15%

Your Work Will Primarily Encompass: 

• With limited supervision, support the development and execution of global regulatory strategies for products in Olema’s pipeline, with a focus on early development and clinical trial applications
• Serve as the Regulatory Affairs representative on global project teams and Study Execution Teams, providing regulatory input and ensuring alignment with program objectives and timelines
• Prepare and coordinate high-quality regulatory global submissions, including INDs, CTAs, amendments, annual reports, DSURs, Investigator Brochures, and briefing documents
• Under the supervision of the Senior Director, Regulatory Affairs, contribute to planning and execution of regulatory interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages, and follow-up correspondence
• Monitor the global regulatory landscape to identify requirements, trends, and potential impact on Olema’s development programs
• Coordinate and maintain health authority reporting schedules in collaboration with cross-functional teams
• Partner with external vendors (e.g., CROs, regulatory consultants) to ensure high-quality and timely submissions
• Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency
• Assist in risk assessment and mitigation planning for regulatory deliverables

Ideal Candidate Profile  

We are looking for a collaborative and driven Regulatory Affairs professional who thrives in a fast-paced environment and brings expertise in regulatory strategy

Knowledge: 

Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred

Experience: 

• Minimum 10 years of related experience with a Bachelor’s degree; or 7 years and a Master’s degree; or a PhD with 5 years experience; regulatory affairs experience in the pharmaceutical or biotechnology industry
• Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence 
• Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines)
• Oncology therapeutic area experience preferred
• Experience collaborating in cross-functional, matrixed teams 
• Experience working with CROs and other partners

Attributes: 

• Strong organizational, project management, and problem-solving skills
• Excellent oral, written, and presentation skills
• Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities
• Self-starter with the ability to work both independently and within teams

The base pay range for this position is expected to be $176,000 - $188,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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About the Role >>> Program Manager, CMC 

As the Program Manager, CMC reporting to the Director, CMC Program Management, you will lead integrated CMC program planning and execution across clinical development stages. You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with Technical Operations (CMC technical leads), Quality, Regulatory, Supply Chain, Finance and external partners. You will serve as an operational leader – driving accountability, facilitating alignment, managing risk, and helping teams navigate challenges effectively.   

This role can be based out of our San Francisco, CA or Boston, MA offices and will require 10% travel. 

Your work will primarily encompass:

• Lead integrated CMC planning across Drug Substance (DS), Drug Product (DP), Analytical (AC), Quality (QA), Regulatory (RA), and Supply Chain (SC), partnering with Director- and Senior Director-level functional leaders to define deliverables, timelines, and priorities aligned to clinical and regulatory goals. 
• Build and maintain integrated project timelines in Smartsheet (or similar tools), ensuring dependencies, critical path activities, and milestones are clearly defined and tracked. 
• Identify program risks, drive mitigation planning with functional leads, and escalate issues as needed to maintain timelines. 
• Facilitate CMC sub-team meetings, document decisions and action items, and ensure follow-through across internal teams and external partners. 
• Prepare leadership-ready status updates and presentations, track key program metrics, and maintain clear documentation of plans, risks, and decisions. 
• Support regulatory submission readiness by aligning CMC deliverables, documentation, and cross-functional inputs to filing timelines. 
• Partner with Technical Operations and CDMOs to drive coordinated execution and proactively identify risks to supply or compliance. 
• Strengthen CMC program management practices, tools, and planning processes to support scalable, efficient execution. 
• Provide program-level budget visibility and tracking in collaboration with functional leads and Finance. 
• Contribute to a collaborative, accountable, and team-oriented culture within CMC and across Olema. 

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor's degree required, Life Sciences or related disciplines preferred. 
• Proficiency in Microsoft Office Suite (PowerPoint, Excel, Outlook), Smartsheet (or equivalent PM tools), and collaboration platforms (e.g., MS Teams, SharePoint). 
• Knowledge of CMC development processes across clinical stages. 
• Familiarity with regulatory submission timelines and CMC documentation requirements preferred. 

Experience: 

• Minimum 5+ years of experience in life sciences program management and/or drug development operations with a bachelor's degree, or 3+ years with a master's degree. 
• Experience driving CMC execution in early clinical-stage development (Phase 1–2), with exposure to Phase 3 readiness considered a plus. 
• Working cross-functionally within drug development teams (Drug Substance, Drug Product, Analytical, Quality, Regulatory Affairs, Supply chain). 
• Demonstrated experience building and managing integrated project plans, identifying critical path activities, and proactively managing risks and dependencies. 
• Collaborating and interacting with external vendors/CDMOs. 
• Experience preparing materials for team or leadership meetings. 

Attributes: 

• Highly organized with strong attention to detail and follow-through. 
• Energetic, proactive, and action-oriented — a true “go-getter.” 
• Friendly and approachable with a collaborative mindset. 
• Strong communicator who can tailor messaging to diverse audiences. 
• Skilled at bridging functions and building strong working relationships. 
• Comfortable navigating a fast-paced, evolving environment. 
• Solutions-oriented with sound judgment and appropriate escalation. 
• Strong team player who thrives in highly collaborative settings. 

The base pay range for this position is expected to be $150,000-$170,00 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MT1

About the Role >>> Program Manager, CMC 

As the Program Manager, CMC reporting to the Director, CMC Program Management, you will lead integrated CMC program planning and execution across clinical development stages. You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with Technical Operations (CMC technical leads), Quality, Regulatory, Supply Chain, Finance and external partners. You will serve as an operational leader – driving accountability, facilitating alignment, managing risk, and helping teams navigate challenges effectively.   

This role can be based out of our San Francisco, CA or Boston, MA offices and will require 10% travel. 

Your work will primarily encompass:

• Lead integrated CMC planning across Drug Substance (DS), Drug Product (DP), Analytical (AC), Quality (QA), Regulatory (RA), and Supply Chain (SC), partnering with Director- and Senior Director-level functional leaders to define deliverables, timelines, and priorities aligned to clinical and regulatory goals. 
• Build and maintain integrated project timelines in Smartsheet (or similar tools), ensuring dependencies, critical path activities, and milestones are clearly defined and tracked. 
• Identify program risks, drive mitigation planning with functional leads, and escalate issues as needed to maintain timelines. 
• Facilitate CMC sub-team meetings, document decisions and action items, and ensure follow-through across internal teams and external partners. 
• Prepare leadership-ready status updates and presentations, track key program metrics, and maintain clear documentation of plans, risks, and decisions. 
• Support regulatory submission readiness by aligning CMC deliverables, documentation, and cross-functional inputs to filing timelines. 
• Partner with Technical Operations and CDMOs to drive coordinated execution and proactively identify risks to supply or compliance. 
• Strengthen CMC program management practices, tools, and planning processes to support scalable, efficient execution. 
• Provide program-level budget visibility and tracking in collaboration with functional leads and Finance. 
• Contribute to a collaborative, accountable, and team-oriented culture within CMC and across Olema. 

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor's degree required, Life Sciences or related disciplines preferred. 
• Proficiency in Microsoft Office Suite (PowerPoint, Excel, Outlook), Smartsheet (or equivalent PM tools), and collaboration platforms (e.g., MS Teams, SharePoint). 
• Knowledge of CMC development processes across clinical stages. 
• Familiarity with regulatory submission timelines and CMC documentation requirements preferred. 

Experience: 

• Minimum 5+ years of experience in life sciences program management and/or drug development operations with a bachelor's degree, or 3+ years with a master's degree. 
• Experience driving CMC execution in early clinical-stage development (Phase 1–2), with exposure to Phase 3 readiness considered a plus. 
• Working cross-functionally within drug development teams (Drug Substance, Drug Product, Analytical, Quality, Regulatory Affairs, Supply chain). 
• Demonstrated experience building and managing integrated project plans, identifying critical path activities, and proactively managing risks and dependencies. 
• Collaborating and interacting with external vendors/CDMOs. 
• Experience preparing materials for team or leadership meetings. 

Attributes: 

• Highly organized with strong attention to detail and follow-through. 
• Energetic, proactive, and action-oriented — a true “go-getter.” 
• Friendly and approachable with a collaborative mindset. 
• Strong communicator who can tailor messaging to diverse audiences. 
• Skilled at bridging functions and building strong working relationships. 
• Comfortable navigating a fast-paced, evolving environment. 
• Solutions-oriented with sound judgment and appropriate escalation. 
• Strong team player who thrives in highly collaborative settings. 

The base pay range for this position is expected to be $150,000-$170,00 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph™ technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com.

Seaport Therapeutics is seeking someone to lead analytical research and development for its portfolio of small molecule programs targeting neuropsychiatric disorders.  The Senior Director, Analytical R&D, reports to the Vice President, CMC and is responsible for providing strategic and technical leadership for analytical development of small molecules within Seaport’s portfolio, from pre-clinical development to late-stage clinical development. This includes oversight of analytical method development, validation, method transfer to CMO’s, and support of regulatory filings, including investigational new drugs (INDs)/investigational medicinal product dossier (IMPDs) and new drug applications (NDAs). The role also includes strategic partnering with Quality, Development & Manufacturing, and Regulatory to deliver uninterrupted clinical supplies to enable Seaport’s current and future clinical studies.

The role will be accountable for delivering analytical methods that are phase-appropriate and adhere to the highest scientific standards. The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, in addition to several years’ experience overseeing analytical development at CMO’s.

The position is responsible for ensuring that all method development, validation and testing (release, stability, and other) performed on behalf of Seaport is conducted in accordance with the appropriate compendial standards, when available, and is compliant to all regulations and industry phase-appropriate testing standards and standard operating procedures.  The Senior Director will also ensure that all testing and testing services coordinate with all other product development activities so that testing does not fall on the critical path and causes product development delays.

The ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a 'we own it' mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement.

Key Responsibilities:

• Serve as the functional head of Analytical Research & Development, accountable for analytical strategy across Seaport’s small‑molecule portfolio from preclinical through late‑stage clinical development.
• Define and implement phase‑appropriate analytical development strategies for drug substance (DS) and drug product (DP), aligned with overall CMC and regulatory objectives.
• Lead and develop the Analytical function within CMC, including direct management of analytical staff and thoughtful planning for future capability needs as the portfolio advances.

• Establish best practices for analytical lifecycle management, data integrity, documentation, and knowledge transfer.
• Define and execute Seaport’s outsourced analytical strategy, including selection, onboarding, governance, and performance management of CDMOs and contract testing laboratories.
• Provide strategic oversight and day‑to‑day governance of CDMO’s, ensuring adherence to scope, timelines, quality standards, and data integrity expectations.
• Provide technical leadership for analytical method development, validation, and transfer for DS and DP, utilizing techniques including (but not limited to) HPLC-CAD, HPLC-UV, GC, LC-MS, LC‑MS/MS, HPLC-FLR, LC-qToF, GC (Residual Solvents), Elemental impurity analysis, IR, qNMR, thermal analysis, droplet size, PSD, lipolysis, and dissolution/ drug release.
• Ensure analytical methods and specifications are scientifically justified, phase‑appropriate, and compliant with applicable compendial standards and regulatory guidelines.
• Review and approve analytical methods, validation protocols, analytical reports, stability protocols, and stability test reports.
• Oversee stability programs, including trending and proactive identification of potential quality or stability issues.
• Collaborate closely with QA, Regulatory Affairs, Development & Manufacturing, Clinical Supply, and Research to ensure alignment across development activities.
• Ensure analytical activities are integrated into overall project plans and do not become a critical path for development timelines.
• Provide analytical CMC leadership for regulatory filings, including INDs, IMPDs, NDAs, and MAAs, with direct responsibility for authoring and reviewing analytical sections.
• Partner with Quality Assurance to support audits of external testing facilities and contribute to Quality and Service Agreements.

Professional Experience/Qualifications:

• MS or Ph.D. in Analytical Chemistry, Physical Chemistry, or a related scientific discipline.
• 12–15+ years of progressive industry experience in small‑molecule analytical development within pharmaceutical or biotechnology organizations.
• Demonstrated experience leading analytical development across multiple development stages, including late‑stage clinical development and registration‑enabling activities.
• Proven experience serving as a functional or sub‑functional leader, including people leadership and accountability for analytical strategy execution.
• Extensive hands‑on expertise in chromatographic and spectroscopic techniques, including GC, LC, IC, chiral separations, and detection methods such as UV/Vis, CAD, MS (SIM/MRM), fluorescence, FID, and ECD.
• Experience managing analytical development and testing activities through CDMOs and contract laboratories in a virtual or highly outsourced operating model.
• Strong knowledge of global regulatory requirements and ICH guidelines applicable to analytical development and control strategies.
• Experience with complex lipophilic drug substances and formulations, including enabling formulation approaches (e.g., SEDDS, soft‑gel dosage forms).
• Demonstrated ability to lead and influence cross‑functional teams in a fast‑paced, resource‑constrained biotech environment.
• Excellent communication, collaboration, and scientific judgment skills, with the ability to make sound decisions balancing speed, quality, and regulatory expectations.
• Willingness to travel internationally approximately 25% of the time.

At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. The expected salary range for this role is $230,000–$270,000, with the final offer based on experience, market data, and internal equity. We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com. 

The Role

Seaport Therapeutics is hiring a Director, Biostatistics to serve as the statistical scientific lead for one or more clinical development programs spanning Phase 1–3 within the Biometrics function. Reporting to the VP, Head of Biometrics, this role will provide strategic statistical leadership and serve as an independent statistical authority, shaping development strategies and representing Biostatistics in regulatory interactions, while also performing and guiding hands-on analysis across the clinical portfolio.

In the near term, the role will focus on leading statistical strategy, trial design, and CRO oversight for active clinical programs, ensuring regulatory defensibility and submission readiness. Over time, this leader will help build a strong statistical culture, mentor junior team members, and serve as a key contributor to the Biometrics leadership team as the organization scales.

The ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a “we own it” mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. This position is based in Boston’s Seaport area, with a strong preference for being onsite 3–4 days per week.

Key Responsibilities

Statistical Scientific Leadership

• Serve as the program‑level statistical lead with end‑to‑end accountability for trial design, analysis, interpretation, and reporting across multiple studies.
• Proactively identify, evaluate, and implement appropriate and innovative statistical methodologies aligned with clinical objectives, regulatory expectations, and risk profile.
• Provide expert judgment on complex statistical issues including multiplicity, missing data, intercurrent events, estimands, sensitivity analyses, and data interpretation.
• Conduct literature review, methodological research, and external benchmarking to support design decisions and defend approaches scientifically.

Clinical Trial Design & Analysis

• Lead the design of clinical trials, including sample size and power calculations; endpoint and estimand strategy (ICH E9(R1)); adaptive, Bayesian, or novel designs where appropriate; and simulation studies to evaluate operating characteristics.
• Translate clinical development questions into statistically sound and efficient designs.
• Author and/or review statistical sections of protocols, SAPs, TFL shells, and clinical study reports, ensuring scientific rigor and regulatory readiness.

Regulatory Strategy & Agency Interaction

• Lead statistical contributions to regulatory interactions (IND/CTA amendments, End‑of‑Phase meetings, Type C, NDA/BLA submissions).
• Prepare and defend statistical approaches in briefing documents, response letters, and meetings with FDA, EMA, and other global health authorities.
• Serve as the statistical lead in addressing regulatory questions, objections, and post‑submission requests, including development of additional analyses as required.

Hands‑On Analysis & Interpretation

• Perform and/or closely guide hands‑on statistical analyses using SAS and R, including ad hoc analyses for safety, efficacy, and decision‑making.
• Ensure analyses are reproducible, traceable, and aligned with agreed‑upon statistical principles.
• Partner with clinical and safety teams to support ongoing data monitoring and signal evaluation.

CRO & Vendor Oversight

• Provide scientific oversight of external CROs and vendors for biostatistics, programming, and data management activities.
• Review and quality‑check SDTM/ADaM datasets, analysis outputs, and define.xml for scientific accuracy and regulatory compliance.
• Ensure end‑to‑end traceability from raw data through analysis and reporting.

Cross‑Functional Collaboration & Influence

• Partner closely with Clinical Development, Regulatory Affairs, Clinical Operations, Pharmacovigilance, and Translational teams.
• Clearly communicate statistical concepts, risks, and recommendations to non‑statistical audiences.
• Mentor junior statisticians and programmers informally; contribute to building a strong statistical culture as the organization scales.

Qualifications

• PhD in Statistics or Biostatistics (or closely related quantitative field with equivalent depth).
• 10+ years of pharmaceutical/biotechnology experience providing biostatistical leadership across clinical development.
• Demonstrated ability to function as a scientific statistical authority, resolving complex design and analysis challenges independently.
• Deep knowledge of regulatory statistical guidance and expectations, including ICH E9, E9(R1), multiplicity, missing data, adaptive designs, and sensitivity analyses.
• Proven experience leading statistical aspects of regulatory submissions and agency interactions.
• Hands‑on expertise in SAS and R, including simulations and advanced analyses.
• Strong understanding of CDISC standards (SDTM, ADaM, Define‑XML) and regulatory traceability.
• Excellent written and verbal communication skills; ability to influence and defend positions with senior stakeholders.
• Experience in CNS/psychiatry or related therapeutic areas is a plus; passion for Seaport’s patient-centric mission is essential.

At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. $198,000-$240,000. We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.

Company Summary

Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, and reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn’s inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source and is designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s AP01 is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF) and is planning a Phase 2 clinical trial. For more information, please visit avalynpharma.com and follow us on LinkedIn.

Position Summary

The Director of Clinical Operations is a senior-level position responsible for overseeing and managing the clinical operations of assigned clinical trials or program of trials. This role plays a critical role in ensuring the successful planning, execution, and monitoring of Avalyn’s global clinical trials and studies. This position will report to the VP of Clinical Operations and can be remote-based anywhere in the United States.

Key Responsibilities (at the study or program level):

• Strategic Leadership: Develop and implement the operations plans and logistics for their assigned study or program of studies aligning with the organization's goals and objectives. Provide leadership and guidance to the clinical operations team, ensuring the successful execution of clinical programs.
• Clinical Trial Management: Oversee the planning, initiation, execution, and completion of clinical trials in accordance with applicable regulations, guidelines, and standard operating procedures (SOPs). Coordinate with cross-functional teams, including outside vendors, medical affairs, regulatory affairs, data management, and biostatistics, to ensure seamless trial execution.
• Resource Management: Indirectly manage external providers’ study or program level resources to support clinical operations. Directly manage internal resources who support the Director’s assigned studies or program level of studies.  Monitor resource utilization and implement strategies to optimize efficiency and productivity.
• Quality Assurance: Ensure compliance with relevant regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal Standard Operating Procedures (SOPs), and other related quality standards. Work directly with the Avalyn Quality Management function to develop and maintain quality management systems to monitor and improve the quality of clinical operations processes.
• Strategic Partner/Vendor Management: Oversee the selection, evaluation, and management of external partners/vendors, such as contract research organizations (CROs), central laboratories, and other service providers. Establish strong relationships with partners/vendors and negotiate contracts to ensure cost-effectiveness and high-quality deliverables.
• Risk Management: Identify and mitigate risks associated with clinical trials, including protocol deviations, adverse events, and data integrity issues. Implement risk management strategies and develop contingency plans to address potential challenges and ensure patient safety.
• Sponsor Oversight and Clinical Trial Management: Develop and implement clinical trial monitoring standards and best practices for effective monitoring of investigational sites and the overall quality and integrity of each assigned clinical trial or program of trials, in accordance with industry standards and practices.
• Team Development: Operate as “one team” through clear and transparent communications and appropriate team building strategies. Provide mentoring, coaching, and performance feedback to enhance individual and team capabilities. Foster a culture of collaboration, innovation, and continuous improvement.
• Stakeholder Engagement: Collaborate with internal stakeholders, such as senior management, clinical development teams, Key External Experts, and regulatory affairs, to align clinical operations strategies with broader organizational objectives. Establish strong relationships with external stakeholders, including investigators, study sites, and regulatory authorities.
• Data Management and Analysis: Working internally/externally with data operations experts to understand the data collection, analysis, and interpretation of clinical trial data.
• Business Process Improvement: Contribute to the identification of business process improvement needs or opportunities, and lead or participate in strategic and continuous business improvement initiatives in study planning & set up, study conduct & close out, vendor and CRO selection and management, budget development & management, and other initiatives to support Avalyn clinical development needs.
• Personnel Management: Provide direct or indirect line management of clinical operations staff contract or consultant staff on an as-needed basis. Mentor and coach CO and other functional department team members on clinical trial operations.  If in a formal line management role, conduct appropriately timed performance reviews, calibration sessions, and feedback discussions.  Perform competency assessments and suggest approaches to address identified developmental opportunities.
• Collaborate with the VP, Clinical Operations and colleagues from other functional groups with responsibilities in the therapeutic program (Clinical Development, Medical Affairs, Regulatory Affairs, Data Management, Finance, and Program Management) to ensure alignment of resources and tasks management to meet Avalyn business needs and to achieve Avalyn corporate goals.

Qualifications and Requirements:

• Degree required with a degree in life sciences, medicine, pharmacy, or a related field preferred. A Ph.D., M.D., or equivalent is appreciated but not required.
• Extensive experience (typically 10+ years) in clinical operations within the healthcare or pharmaceutical industry, including significant experience in clinical trial management.
• Experience in rare diseases and respiratory diseases/research highly preferred.
• Strong working knowledge of applicable regulatory guidelines and requirements (e.g., FDA, EMA), as well as ICH-GCP and other relevant industry standards.
• Proven leadership and management skills, with the ability to lead and motivate cross-functional teams.
• Excellent organizational, planning, and project management abilities, with the capacity to handle multiple priorities and meet tight deadlines or successfully negotiate modifications.
• Strong problem-solving and decision-making skills, with a focus on driving inspection readiness, continuous improvement, and operational excellence.
• Demonstrated successful experience managing/overseeing Contract Research Organizations (CROs), vendors and other 3^rd party suppliers
• Experience working across all phases of clinical development (Phases I – III; phase IV experience helpful)
• Working medical and scientific knowledge; experience in the Respiratory Therapeutic Area strongly desirable
• Prior experience as Clinical Research Associate (CRA/monitor), Lead CRA, or Project Manager at either Sponsor, CRO helpful but not required
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels.
• Experience in vendor management and contract negotiation is desirable.
• Familiarity with clinical trial technology and data management systems is an advantage.

Business Requirements:

• Limited business travel domestically and internationally may be required.
• Fully remote position.
• Ability to communicate in English (written and verbal). Fluency to read or speak other languages is beneficial.