Who We Are

Weber Shandwick is more than a leading global PR agency – we’re an engagement agency and we’re working in and around the cutting edge of the new media landscape. We’re storytellers, content creators, and we engage people IN the story. Our success is built on a deep commitment to client service and to our people. We embrace creativity and collaboration, and we engage stakeholders in new and creative ways to build brands and reputations.

Senior Vice President, Client Experience, Corporate Health

About Weber Shandwick Healthcare

Weber Shandwick partners with leading healthcare companies to address critical health challenges through innovative, award-winning communications strategies. Our success stems from our collaborative culture, deep scientific expertise, and integrated capabilities—supported by our global network and driven by exceptional talent.

About the Role

We're seeking an accomplished healthcare communications leader to serve as a strategic partner leading clients, new business efforts and operations as part of the Boston Health team leadership. This critical role combines senior client leadership with hands-on execution for corporate healthcare and corporate health social assignments.

You will be a trusted advisor and operational leader who:

• Serves as the primary day-to-day strategist and relationship manager for key corporate healthcare clients
• Leads and scales our corporate health social media practice with strategic vision and execution excellence
• Manages complex, integrated teams with commercial acumen and efficiency
• Balances big-picture thinking with meticulous attention to detail
• Demonstrates the professional maturity and judgment

This is an opportunity to shape the future of corporate healthcare communications with clients and our agency while partnering with senior leaders and great thinkers in Boston and across our network.

Key Responsibilities

Client Leadership & Business Growth

• Own day-to-day client relationships and serve as the trusted strategic counsel on corporate healthcare communications assignments
• Drive client satisfaction and organic growth by anticipating needs and delivering innovative solutions
• Lead new business development efforts, from pitch strategy to presentation
• Manage the commercial aspects of large accounts, including budgets, resources, and profitability

Corporate Healthcare & Social Media Expertise

• Develop and execute integrated corporate communications strategies that address business challenges in healthcare's evolving landscape (policy, reputation, stakeholder engagement, issues management)
• Lead corporate health social media strategy and execution, staying ahead of platform innovations and best practices
• Navigate the intersection of corporate affairs, regulatory environment, and digital communications
• Provide thought leadership on emerging trends in the corporate health space and stay ahead of shifts in healthcare corporate affairs, media landscape, and communications technology

Team Leadership & Development

• Build, mentor, and inspire high-performing teams across offices and disciplines
• Coach team members to achieve their professional goals while maintaining quality standards
• Deploy teams strategically to maximize efficiency and impact
• Foster a culture of collaboration, curiosity, and continuous improvement

Required Qualifications

• Bachelor's degree
• 10+ years of progressive healthcare communications experience, including substantial agency background
• Proven expertise in corporate healthcare communications (corporate reputation, issues management, executive visibility, stakeholder engagement)
• Demonstrated leadership in healthcare social media strategy and execution
• Track record managing large pharmaceutical or healthcare accounts with complex, multi-market teams
• Deep understanding of the pharmaceutical/healthcare landscape and corporate affairs environment
• Excellence in client relationship management with ability to operate independently with senior client stakeholders
• Strong commercial acumen
• Exceptional written, verbal, and presentation skills
• Proven ability to lead, develop, and retain talent
• Proficiency in MS Office; advanced skills in PowerPoint and presentation platforms

What Sets You Apart

• Professional maturity and judgment to navigate complex situations independently
• Results-driven mindset with focus on measurable outcomes
• Entrepreneurial spirit combined with collaborative leadership style
• Culture champion who leads by example and inspires teams

Salary Range: $171,000 USD – $230,000 USD

Where an employee or prospective employee is paid within this range will depend on, among other factors, actual ranges for current/former employees in the subject position; market considerations; budgetary considerations; tenure and standing with the company (applicable to current employees); as well as the employee’s/applicant’s background, pertinent experience, and qualifications.

Weber Shandwick is proud to be an Equal Opportunity/Affirmative Action employer. Weber Shandwick recruits qualified applicants without regard to race, color, religion, gender, age, ethnic or national origin, protected veteran status, physical or mental disability, sexual orientation, gender identity, marital status or citizenship status.

#LI-GH

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

Position Description

The Director, Regulatory Labeling, Advertising & Promotion (LAP) is responsible for leading global product labeling and U.S. advertising and promotion regulatory activities across the company’s portfolio. This role provides strategic and operational leadership to ensure labeling and promotional materials are scientifically accurate, compliant with regulatory requirements, and aligned with corporate and commercial objectives.

The position serves as a key regulatory partner to Clinical Development, Medical Affairs, Commercial, Legal, and Safety, and plays a central role in labeling strategy, lifecycle management, and promotional material review in a highly regulated environment, for cell and gene therapy products.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

Job Duties and Responsibilities

Core Responsibilities:

Labeling

• Lead the development, negotiation and lifecycle maintenance of global and US product labeling, including pre- and post- approval updates.
• Drive development and maintenance of Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI), ensuring alignment with global regulatory expectations.
• Establish and operationalize labeling strategies that result in clear, concise, compliant and scientifically robust product labels.
• Provide regulatory leadership for labeling-related interactions with Health Authorities, including briefing documents and responses to inquiries.
• Ensure final labeling content meets internal standards and regulatory authority requirements prior to submission or implementation.

Advertising and Promotion

• Oversee regulatory review of US promotional and select non-promotional materials. across channels, ensuring compliance with FDA regulations and enforcement trends
• Serve as the regulatory lead and reviewer for Medical-Legal-Regulatory (MLR) review.
• Partner with Commercial, Medical Affairs and Legal to proactively identify and mitigate regulatory risk in promotional strategy and execution.
• Monitor and interpret FDA enforcement actions and policy developments related to advertising and promotion, translating insights into internal guidance and best practices.
• Develop submission strategy for efficient and appropriate health authority review of promotional materials; and ensure the compliant and timely submission of promotional materials to Health Authorities.
• Create and manage promotional submissions documents in the electronic database and partner with Regulatory Operations on submissions.

Governance, Process and Compliance

• Support or co‑lead the Labeling Review Committee (LRC) and provide regulatory oversight of labeling governance processes.
• Develop, maintain, and improve SOPs, workflows, tools, and training related to labeling and Ad/Prom review.
• Ensure inspection readiness and documentation compliance for labeling and promotional activities.
• Drive consistency and operational excellence across labeling and Ad/Prom processes globally.

Cross-Functional Leadership

• Act as a strategic regulatory advisor to Clinical, Safety, Medical Affairs, Commercial, Quality, and Regulatory Strategy teams.
• Lead and mentor internal staff and manage external vendors or consultants as needed.
• Contribute to broader regulatory strategy discussions.

Essential/Required Qualifications:

• Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies.
• Experience supporting FDA interactions related to labeling and promotional compliance
• Experience with MLR review and developing Company Core Data Sheets
• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• Proven ability to lead cross-functional teams and to operate in a matrixed organization, including leadership without direct authority.
• Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree)
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• Ability to influence without authority and partner effectively with senior leaders.
• Strong attention to detail and accuracy with sound judgement and risk-based decision making.
• Entrepreneurial and self-directed, able to prioritize work to meet targets and timelines, motivates others, demonstrates tact and diplomacy, and has a flexible and positive solution-oriented approach.

Key Competencies:

• Deep understanding of FDA regulations and guidance governing labeling and promotional materials.
• An aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts.

About Every Cure:   

Every Cure is an AI-driven nonprofit, biotech organization on a mission to save and improve lives by repurposing existing medicines for diseases with significant unmet need. We are working to create a world where every drug is used to treat every disease it possibly can, so that no patient suffers when an existing treatment could help them. We are filling a gap left by the current biomedical system, which doesn’t systematically pursue new uses for old drugs. Through artificial intelligence technologies, collaboration with healthcare professionals, and patient advocacy, Every Cure is dedicated to unlocking the full potential of existing medicines to treat every disease and every patient we possibly can. Inspired by Every Cure’s co-founders' work repurposing drugs for Castleman disease and other rare diseases, Every Cure is advancing repurposed treatments for neglected diseases and has been featured in The New Yorker,  New York Times, USA Today, Good Morning America and other news media. Led by a talented leadership team and an outstanding Board of Directors, Every Cure is supported through funding from leading philanthropic organizations like Chan Zuckerberg Initiative, TED’s Audacious Project, and ARPA-H. 

 Our approach:  

• AI-Powered Identification: We use advanced artificial intelligence to analyze the world’s biomedical knowledge and identify FDA-approved drugs that can be repurposed for untreated conditions. This cutting-edge technology enables us to explore new therapeutic possibilities efficiently.  
• Open-Source Commitment: We are dedicated to making our predictive pipeline open-source, fostering collaboration and transparency within the scientific community and unlocking the potential for discovering new treatments.  
• High-Impact Focus: We prioritize drug repurposing opportunities that will relieve the most suffering and have the greatest impact possible.  
• Rigorous Validation: Promising opportunities are thoroughly validated through laboratory and clinical studies to confirm their efficacy and safety before advancing to broader application.  
• Strategic Marketing and Access: We disseminate information about effective repurposed treatments through multiple channels and are committed to ensuring that new cures are accessible to all patients.

Applicants must reside in the state specified at the top of this job posting. Residency in that state is a requirement for consideration and must be maintained for the duration of employment.

The Head of Clinical Development leads Every Cure’s clinical research and development function, serving as both strategic architect and working clinical lead on priority programs. They manage a diverse portfolio of drug repurposing initiatives including Every Cure-sponsored interventional trials (with full sponsor IND accountability and REMS complexity where applicable), collaborative investigator-sponsored trials, and Every Cure-led patient registries, natural history studies, and other real-world studies. They collaborate directly with computational and data science teams to translate AI-driven repurposing hypotheses into clinically testable programs and represent the organization to external partners and stakeholders. This role owns sponsor compliance under ICH E6(R3) including maintenance of the clinical QMS and SOP infrastructure regardless of CRO engagement  and oversees regulatory strategy and dissemination. The HCD supports Every Cure’s CSO and engages directly with external stakeholders including CROs, clinical trial technology vendors, academic investigators, patient advocacy organizations, the IRB of record, and FDA. The HCD helps build and lead a lean internal clinical development team, modeling the working-leader norm expected in a small, mission-driven organization.

How you will make an impact: 

Strategic Leadership of Clinical Development and Medical Affairs

• Set the direction for Every Cure’s clinical research and development, ensuring alignment with the organization’s mission to repurpose FDA-approved drugs for high-impact unmet needs, while personally leading or co-leading priority programs.
• Lead the execution of organizational goals through operational planning and cross-functional integration, personally owning project timelines, quality standards, and accountability metrics for priority programs rather than delegating all execution.
• Provide expert counsel to the CSO, President and Scientific Advisory Council on medical strategy, program development, and organizational growth.

Research and Clinical Development Oversight

• Design, author, and review key study documents (protocols, statistical analysis plans, informed consent documents, clinical study reports, investigator brochures) for Every Cure-sponsored clinical trials, patient registries, natural history studies, and real-world evidence assessments. Own study design decisions end-to-end, from scientific rationale through data integrity and analysis.
• Serve as sponsor medical lead and/or medical monitor on Every Cure-sponsored IND-holding studies (delegating per-study where appropriate), ensuring all research activities are ethically sound, methodologically rigorous, and regulatory compliant under FDA 21 CFR Part 312, ICH E6(R3), and ICH E9 principles.
• Translate complex medical findings into strategic decisions regarding program continuation, optimization, or sunsetting, based on efficacy, feasibility, and patient impact.
• Responsible for compliance and oversight of the Human Subjects Research program at Every Cure, including IRB (Advarra) submissions and amendments, sponsor safety reporting (IND safety reports, DSURs), SAE adjudication, signal detection, and REMS program participation where applicable (e.g., lenalidomide).

Portfolio Strategy and Program Management

• Partner on strategic prioritization and dynamic management of Every Cure’s diverse portfolio of drug repurposing opportunities, applying a risk-adjusted, impact-oriented lens to maximize outcomes.
• Direct the progression of programs through clinical and dissemination stages, using insights from AI models and external scientific inputs. Personally lead CRO and clinical technology vendor selection, contracting input, and ongoing governance (joint steering committees, KPIs, oversight plans) for highest-priority programs.
• Develop and manage resource allocation frameworks across disease areas and therapeutic modalities, ensuring optimal investment of time, talent, and funding toward the most promising interventions.

Leadership and Team Development

• Build, mentor, and lead a lean, high-performing team of clinical research and medical professionals united around a shared vision of maximizing patient impact through drug repurposing, modeling a working-leader norm in which senior leaders contribute directly alongside their teams.
• Define roles, responsibilities, and performance standards for the clinical team while fostering a culture of excellence, integrity, psychological safety, and cross-functional collaboration.
• Promote continuous learning and growth through coaching, training programs, and development opportunities that build both individual capability and team effectiveness.

Stakeholder Engagement, Compliance, and Dissemination

• Act as medical spokesperson and lead regulatory interface for Every Cure in public, scientific, and regulatory forums (including FDA pre-IND and Type B/C meetings), promoting the organization’s mission and sharing results from preclinical and clinical programs.
• Cultivate and manage partnerships with CROs, patient advocacy groups, academic institutions, and regulatory agencies to ensure successful execution and wide-scale impact of therapeutic programs.
• Guide the regulatory approval and post-study dissemination strategies to ensure timely and effective translation of research into therapies accessible to patients, including peer-reviewed publications, policy briefs, and healthcare provider outreach.
• Partner with the Impact lead to provide input and perspective on dissemination and to engage with key stakeholders to ensure medicines reach patients.

What you bring to the team:

Education 

• MD or MD/PhD preferred; PhD DO, or PharmD acceptable

Work Experience (Two-Tier: Head of / VP)

• Minimum for Head of Clinical Development: 8+ years of clinical development experience post-MD (or equivalent), including service as clinical lead on at least one sponsor-held Phase 2 trial from protocol through database lock.
• Demonstrated leadership experience recruiting, mentoring, and managing cross-functional clinical teams, with explicit willingness and proven ability to work hands-on alongside direct reports in a small-organization setting.
• Expertise in drug development, clinical trial design (including interventional trials in rare or ultra-rare populations), and clinical decision-making.
• Sponsor-side experience running Phase 2 trials (distinct from CRO or academic investigator experience).
• Experience working across more than one therapeutic research area.
• Experience with small-sample trial designs and natural history or registry data.
• Proven leadership in driving strategic initiatives and cross-functional collaboration to advance scientific and organizational goals.

Preferred for Vice President designation:

• 12+ years of clinical development experience, including prior functional leadership at a sponsor (Executive Director, Head of, or VP level); multiple sponsor-held INDs led through Phase 2 or beyond; direct experience with REMS programs, risk-based monitoring, or similarly complex regulatory programs; and prior responsibility for building or scaling a clinical QMS under ICH E6(R3) or predecessor standards.

Skills 

• Proficiency in clinical research, real-world evidence assessments, evidence generation, patient registry design, clinical trial execution, and sponsor-side pharmacovigilance.
• Working knowledge of FDA IND regulations (21 CFR Part 312), ICH E6(R3) Good Clinical Practice, ICH E9 statistical principles, 21 CFR Part 11 for electronic records, and REMS program requirements; familiarity with EU CTR a plus.
• Exceptional communication and presentation abilities.
• Demonstrated ability to foster and sustain a collaborative, cross-functional culture grounded in shared organizational mission and values.
• Able to partner effectively with computational and data science teams and critically evaluate AI/ML-driven repurposing hypotheses for clinical translatability.
• Strategic thinker with a focus on urgency, efficiency, and impact.
• Passionate about Every Cure’s mission and values.
• Highly adaptable, thriving in a fast-paced, start-up environment.
• Explicit willingness to be hands-on: comfort authoring and reviewing key clinical documents (protocols, SOPs, CSRs), directly managing vendor/CRO relationships, and working alongside junior staff rather than exclusively through delegation. Candidates seeking a purely oversight or figurehead role are not a fit for this position.

Compensations & Benefits: 

• Your paycheck: Competitive salary based on experience, ranging from $250,000 - $275,000 annually. 
• Health and wellness: Comprehensive plans with medical, dental, and vision coverage, plus a Flexible Spending Account (FSA) for eligible healthcare expenses. 
• Future nest egg: A 403(b)-retirement plan with an employer match of 3.5% helps you save for your future. 
• Relax and recharge: Generous time off, including paid time off and paid holidays. 
• We have you covered: Comprehensive paid leave for family and medical needs, ensuring you have the support you need during important times. 

This role is based in Cambridge, MA, with an expectation of minimum 3 days per week in office.  

Every Cure is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetics, or any other characteristic protected by federal, state, or local laws.

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.  

Job Title: Associate Director, CMC Lead, Late-Stage Biologics      

Location: Remote OR Hybrid 3 days/week in office if located near Waltham, MA will be required.         

Role Overview: The Associate Director of CMC Leadership will provide technical and strategic leadership for late-stage CMC activities supporting the development, characterization, validation, licensure application, commercial readiness, and lifecycle management of biologics manufacturing process, with a focus on monoclonal antibodies. This role is a critical addition to our growing organization and is highly visible within the CMC team and across other functions. Serving as a matrix leader, this role will work closely with the CMC function leads in drug substance, drug product, analytical, and clinical supply chain. This role will also partner closely with Program Management, Quality, Regulatory Affairs, CDMOs, and consultants.

The ideal candidate is an established technical and matrix leader with hands-on technical experience in biologics process development and manufacturing support, and proven track record in leading cross-functional teams to achieve complex technical and regulatory milestones and bring late-stage biologics therapeutics to commercialization.

Key Responsibilities: 

• Oversee technical operations and lead strategy discussions for late-stage CMC activities including process characterization, PPQ, licensure application, regulatory inspection, and lifecycle management of monoclonal antibody therapeutics.
• Work with internal and CDMO CMC teams to ensure timely delivery of PC & PPQ protocols and reports, in-process-control documents, process validation master plan, and BLA Module 3 sections.
• Lead CMC meetings and ensure drug substance, drug product, analytical, clinical supply chain, quality, program management, and regulatory affairs teams are aligned with overall CMC and program strategy.
• Maintain an effective action tracker for internal and external CMC deliverables. Adapt to changing priorities to ensure corporate CMC objectives are at the forefront.
• Facilitate problem solving, action planning, and decision making within the CMC team while keeping program level stakeholders informed at regular intervals.
• Foster a strong relationship with CDMOs and consultants. Ensure the external partners are fully aligned on Oruka strategy and goals.
• Liaise with internal and external stakeholders to support timely completion of technical. documents, batch records, campaign readiness, lot release, campaign reports, change controls, deviation investigations, and CAPAs.
• Partner with CDMO counterparts to oversee all CMC service, ensuring high quality work, timely delivery, and efficient meetings.
• Collaborate with manufacturing and clinical supply chain stakeholders to ensure robust clinical supply and distribution plans.
• Drive preparation and presentation of CMC content for internal and external meetings, facilitate cross-functional offsite workshops, and help organize business review meetings with CDMOs
• Support the diligence process and contract negotiation with new CDMOs and consultants.
• Work with program managers and Finance to track budgets, contracts, and change orders.
• 20-25% travel in support of diligence process, strategy discussion meetings, and activity supervision at CDMOs.

Qualifications:

• Master’s or PhD in relevant disciplines with 10+ (MS) or 7+ (PhD) years of experience in biologics CMC functions including upstream, downstream, analytical, and drug product.
• Must have experience leading late- and commercial-stage CMC activities including process characterization, PPQ, BLA, regulatory inspections, life cycle management, and post approval submissions.
• Prior matrix leadership experience is highly preferrable. Have led cross-functional CMC teams to drive strategy alignment on risk mitigation, resource planning, process validation, regulatory filing, and post approval changes.
• Experience with pre-filled syringe and/or auto-injector is a plus.
• Strong program management skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets.
• In-depth knowledge of CMC quality and regulatory requirements in support of global regulatory filings
• Experience with managing CDMOs. Demonstrated track record of successful tech transfers to commercial CDMOs
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders
• Strong sense of urgency and ability to direct the CMC team towards their deliverables in a highly fast paced environment

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA -OR-remotely, is $182,000 to $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

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

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

What You’ll Do:

Reporting to the Senior Medical Director, Global Patient Safety and Pharmacovigilance (DSPV), the Medical Director will provide strategic, scientific, and tactical leadership for global medical safety evaluation and benefit-risk management for assigned Kailera products throughout their lifecycle with focus on patient well-being and compliance with applicable regulatory requirements.

This role is instrumental in ensuring patient safety, regulatory compliance, and robust characterization of benefit-risk in both clinical development and real-world use, including shaping risk-management strategies, integrated evidence generation planning, and real-world evidence approaches. 

The medical director will collaborate extensively across and within their own function to advance Kailera’s pharmacovigilance strategy to support the company’s evolving pipeline, innovation, and mission. 

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Provide expert medical interpretation of safety data from all sources (clinical, post-marketing, literature, and RWE) and perform medical review of Individual Case Safety Reports (ICSR) within the ARGUS database
• Oversee and execute safety signal detection and evaluation activities, ensuring timely, scientifically sound assessments and the optimization of signaling systems through data visualization and analysis tools
• Incorporate insights from real-world data (EHRs, claims, registries) into surveillance and benefit-risk assessments to support evidence-generation strategies
• Lead the development and oversight of global benefit-risk assessments and safety surveillance for clinical development programs and post-marketing phases
• Drive the lifecycle management of Risk Management Plans (RMPs) and other risk minimization strategies, ensuring proactive identification and mitigation of safety risks
• Lead the authoring and medical review of safety sections for regulatory documents (IBs, Protocols, DSURs, PSUR/PBRERs, and RMPs) and safety modules for marketing applications
• Support labeling decisions and contribute medical expertise to safety communications, risk materials, and scientific publications
• Collaborate with cross-functional stakeholders to integrate safety considerations into clinical development, post-marketing activities, and evidence-generation strategies
• Lead and inspire a team of PSPV MDs, scientists, and operational colleagues, fostering a culture of accountability, scientific excellence, and collaboration
• Partner with senior leadership (SVP/Medical Director) on departmental goals, organizational design, budgeting, and long-term pharmacovigilance planning
• Act as a Subject Matter Expert (SME) for safety technology strategies, identifying innovative technical or resourcing solutions to improve DSPV surveillance capabilities
• Contribute to the design, implementation, and enhancement of drug safety processes and systems to ensure high-performance PV operations
• Maintain the medical safety governance framework, ensuring the timely identification, assessment, and escalation of significant safety issues
• Represent the PSPV function during audits and inspections, leading the preparation of responses and managing deviations or CAPAs related to medical safety science.
• Drive the development of SOPs, work instructions, and "fit-to-purpose" pharmacovigilance training for internal and external partners

Required Qualifications:

• 8+ years of experience in global pharmacovigilance
• 2+ years of experience in clinical practice or academic medicine
• Proven experience in safety data analysis, signal management, and benefit-risk evaluation
• Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar)
• Demonstrated ability to develop and implement drug safety strategies, risk management plans, and safety governance models
• Proven experience with authoring or contributing to clinical study and regulatory submission documents
• Thorough knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
• Strong knowledge of global safety and pharmacovigilance regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)
• Experience in creating or managing working documents such as SOPs or Work Instructions
• Strong ability to proactively identify risks and initiate/manage risk minimization activities
• Strong ability to lead in a cross functional setting and work collaboratively with internal and external partners in a fast-paced environment
• Strong ability to prioritize, multitask, and deliver quality results that meet tight timelines
• Ability to influence and keep teams focused and motivated
• Strong ability to communicate complex issues clearly

Preferred Qualifications:

• Experience in pharmacoepidemiology, data science, or medical affairs is a plus

Education:

• MD, DO or equivalent medical degree required. Ph.D. degree is a plus

Job Title: Executive Medical Director, Clinical Development         

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.          .          

Role Overview: The Executive Medical Director of Clinical Development plays a key role in leading the design, execution, and oversight of clinical trials at an asset level, ensuring high-quality data generation to support the safety and efficacy of our pipeline products.  This role involves leading and developing a team and contributing to and influencing clinical development strategy across an asset, including study design, implementation, and data interpretation, while working cross-functionally to align clinical activities with overall development plans.  The Executive Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives in a fast-paced environment.  The role reports to the Vice President of Clinical Development. 

Key Responsibilities:

• Strategic Leadership:
• Drives the clinical development strategy for one or more assets
• Identifies critical clinical development milestones and ensures team alignment and accountability toward meeting timelines
• Provides leadership to the clinical team’s contribution to clinical study reports, key clinical documents, and regulatory submissions
• Directly manages and/or mentors Medical Directors, Clinical Scientists and other team members as appropriate
• Clinical Trial Design and Oversight:
• Leads and contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
• Oversees the conduct of clinical trials, ensuring adherence to protocols and good clinical practice (GCP) guidelines, working closely with CROs and external partners to ensure efficient execution
• Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug, driving timely, data-driven decisions
• Manages the clinical contribution to documents required during development (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)
• Medical Expertise:
• Provides deep medical and scientific expertise in the therapeutic area, disease state, and potential drug effects 
• Reviews clinical data to identify and analyze safety concerns and adverse events, working with the pharmacovigilance team on continual benefit-risk assessment
• Stays current with relevant medical literature and clinical trial methodologies

• Contributes medical expertise to external interactions, including KOL engagement, advisory boards, and regulatory interactions as appropriate

• Cross-Functional Collaboration:
• Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pharmacovigilance, pre-clinical and project management teams to ensure alignment between clinical strategy and execution in a fast-paced environment
• Presents clinical data to internal and external stakeholders as appropriate
• People Leadership & Team Development:
• Leads and develops a high-impact team
• Provides coaching, mentorship, and performance management
• Fosters a culture of accountability, collaboration, and scientific rigor
• Supports hiring and resource planning in partnership with leadership

Qualifications:

• Medical degree (MD) ideally with board certification in a relevant specialty
• Extensive experience in clinical research and development, including within the pharmaceutical industry with progression of career demonstrating clinical leadership
• Proven people leadership experience, including managing and developing direct reports in small or growing teams
• Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements, ideally with Phase 2 and 3 clinical study experience
• Excellent communication, leadership, and analytical skills
• Demonstrated ability to contribute to and influence clinical strategy while driving hands-on execution 

Experience working in a small or emerging biotech environment, with comfort operating in a fast-paced setting

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates is $331,000 to $368,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Your Impact

You will design and lead the strategy that unlocks scalable procurement and partner-driven growth across our US Public Sector business. By building and optimizing our state and cooperative contract portfolio, activating high-impact commercial partnerships, and proactively clearing procurement hurdles for new products, you will remove friction from the buying process, expand market access and accelerate revenue growth. This role sits at the intersection of Sales, Legal, Product, Finance, and Government Affairs — translating go-to-market priorities into executable contracting and commercialization frameworks that drive measurable growth.

What You’ll Do

Location: This role is based out of our Boston, MA office and follows a hybrid schedule. We rely on in-person collaboration and ask that team members work onsite Tuesdays through Fridays, with the flexibility to work remotely on Mondays, unless there is an approved workplace accommodation. We believe that connection fuels innovation, and our in-office culture is designed to foster meaningful teamwork, mentorship, and shared success.
Reports to: Senior Director, Strategy & Enablement
Direct Reports: None

State & Cooperative Contract Strategy

• Develop and execute a forward-looking state and cooperative contract strategy aligned to go-to-market priorities; anticipate procurement needs 12–18 months in advance and establish required vehicles ahead of revenue timelines.
• Establish, expand, and renew statewide and cooperative contracts to include new products, services, and pricing models that support growth objectives.
• Lead negotiations for new and expanded contracts, aligning Legal, Sales, Finance, and external stakeholders to secure favorable commercial and operational terms.
• Own strategic relationships with cooperative purchasing organizations and evaluate new vehicles based on revenue potential and market coverage.
• Track contract utilization and performance, identifying opportunities to optimize scope, usability, and adoption across priority markets.

Commercial Partner Strategy & Activation

• Operationalize new commercial partnerships identified by Corporate Development by designing the revenue activation plan and establishing repeatable pathways to secure the first deals on Axon paper.
• Identify priority accounts and use cases where partner products strengthen Axon’s solution; align Sales, Product, Marketing, and the partner on positioning, pricing, and enablement readiness.
• Build scalable procurement and contracting frameworks that allow Axon to compliantly resell partner products within public sector constraints, tracking early performance and refining activation strategy based on results.

New Product Growth Enablement

• Proactively identify and remove procurement, contracting, and regulatory barriers that could delay adoption of new products in state and local markets.
• Ensure state-specific requirements and contract inclusion strategies are understood early and addressed in alignment with launch revenue timelines.
• Translate complex procurement considerations into actionable guidance for Sales and Enablement teams.

What You Bring

• 7+ years of experience in public sector strategy, government contracting, channel/partner strategy, business development, or sales operations within a complex, multi-stakeholder environment.
• Demonstrated success designing and executing strategies that expanded market access and accelerated revenue growth.
• Experience operationalizing commercial partnerships or resell models, translating partnership agreements into executable revenue plans.
• Comfortable balancing legal, financial, and commercial considerations in negotiations.
• Proven ability to influence senior stakeholders and drive cross-functional alignment without direct authority.
• Experience supporting new product launches or commercialization strategies within regulated or procurement-constrained markets.
• Analytical mindset with ability to assess performance metrics, identify friction points, and refine strategy based on data.
• Strategic thinker with a bias for action and a track record of delivering complex, long-horizon initiatives to completion.
• Deep understanding of public sector procurement, including statewide master contracts and cooperative purchasing organizations is a plus.
• Experience in Government Technology, SaaS, or Public Safety Technology preferred.

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs
• And yes, we have snacks in our offices

Benefits listed herein may vary depending on the nature of your employment and the location where you work

About the Role

We are seeking a highly motivated, proactive, strategic, and solution-focused Head of Clinical Operations. This hands-on position will lead and support all aspects of clinical trial operations including planning, implementation, execution, and management of clinical studies by overseeing day-to-day operations, including direct management of outside Clinical Research Organizations (CROs) for several clinical stage oncology assets. In this role, the Clinical Operations leader will manage multiple priorities in a fast-paced environment and enact quick problem solving to ensure the successful conduct of clinical trials and the timely delivery of high-quality data. This role will oversee early and late phase trials with an emphasis on proactivity and creative solutions to overcome regulatory and operational hurdles. The successful candidate will have experience, and interest in, working in a small, dynamic environment with broad responsibilities.

Responsibilities

• Develop and lead a team of clinical operations professionals to ensure high-quality execution of early and late phase clinical trials and the professional development of team members.
• Serve as subject matter expert in clinical operations, providing guidance and expertise to cross-functional teams, including clinical development, regulatory affairs, and data management.
• Provide operational expertise and strategic input to Clinical Development Plans and support the overall clinical strategy for clinical programs. 
• Proactively communicate study plans, progress, risks and mitigations with senior leaders.
• Develop, implement, and modify when needed a successful resource and outsourcing model to meet the evolving demands of an expanding clinical portfolio.
• Manage study site selection, qualification, initiation, and monitoring activities to ensure that clinical trials are conducted according to the study protocol and in compliance with regulatory requirements.
• Evaluate and negotiate budgets, oversee selection and provide oversight and management of CROs, consultants and vendors to ensure the effective and timely execution of clinical trials, with high quality (including inspection ready) and within agreed budget.
• Monitor progress of clinical activity and report on the progress of clinical trials including budget, timelines, enrollment, and data collection / review. 
• Participate in the creation, review, and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
• Coordinate the delivery of clinical trial supplies in collaboration with CRO and other company team members.
• Develop and maintain strong relationships with clinical investigators and study site staff to ensure site performance, patient enrollment, and data quality; perform periodic visits to sites and/or vendors to assess progress and compliance.
• Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial and provide subject matter expertise for regulatory inspections.
• Maintain knowledge across the clinical operations team of program specific therapeutic areas, current medical practice, and pharmaceutical regulations in order to ensure best practice across all activities and appropriate communication to study sites.
• Proactively implement process improvements and innovative approaches. Support the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.

Qualifications:

• Bachelor’s degree (BA/BS) in a relevant scientific field (e.g. nursing, biology, biochemistry, or related areas); advanced degree preferred.
• At least 15 years of experience of successfully leading studies within clinical research operations. Experience with both small and large biotechnology companies is favorable.
• Experience in Phase I-III oncology clinical studies. Global experience preferred.
• Demonstrated expertise building and managing clinical operations teams.
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
• Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
• Experience with agency submissions and inspections, understands adherence to SOPs, ICH/GCP, and FDA and other health authorities’ regulations.
• Forward thinking mindset with ability to manage multiple projects, identify and resolve issues.
• Strong analytical, organizational, and time management skills with a track record of identifying and implementing novel solutions and problem-solving.
• Demonstrated agility and ability to navigate and be successful in a fast-paced, dynamic work environment.
• Proven hands-on leadership and communication skills (written and verbal).
• Team player who collaborates effectively with internal stakeholders as well as external contract organizations.
• Be a champion of a highly collaborative, transparent, data driven, “make it happen” culture.

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown, MA is $319,333 - $375,665. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.

Recruitment fraud statement

Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:

• Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
• We do not conduct interviews through Skype or Telegram.
• Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.
• You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
• To report job scams, head to ReportFraud.ftc.gov.

Position Summary:

The Director of Scientific Communications & Evidence Generation will be responsible for developing a plan for disseminating the company’s scientific data (manuscripts, abstracts, posters, presentations); as well as identifying clinical evidence gaps, overseeing non-registrational research, and collaborating with cross-functional teams to generate real-world evidence (RWE), health economics and outcomes research (HEOR), and investigator-sponsored research (ISR) to support product value and safety profiles. This role requires strong scientific writing skills, advance understanding of industry best practices related to publication-related and research-related compliance, as well as cross-functional leadership savvy.

Key Responsibilities:

Scientific Communications & Publication Planning

• Develop and maintain and 18-month publication plan and lead the publication review process (abstracts, posters, oral presentations, manuscripts, review articles, etc) in compliance with GPP (Good Publication Practice) and ICMJE authorship criteria, as well as data transparency, and fair balance.
• Utilize innovative formats (micro‑learning, interactive pathways, patient‑friendly visuals) and ensure accessibility for diverse audiences
• Maximize the scientific impact of company data via the strategic selection of journals and congresses
• Collaborate with internal/external expertsand vendors to draft content and ensure the scientific accuracy of all data to be presented.
• Maintain the enterprise scientific lexicon and core claims matrix; ensure consistency across materials and channels.

Data Generation: 

• Lead the development of an integrated evidence generation plan (IEGP) aligned with overall medical affairs goals to address unmet needs in collaboration with Clinical Development, Regulatory, HEOR, and Commercial teams to avoid duplicative efforts. 
• Evaluate and acquire new data sources (clinical trials, RWD, registries) to support evidence plans.
• Create processes for synthesizing feedback from various sources, including field insights and advisory boards and analyze the data to uncover trends and actionable insights to guide scientific communication and strategic decision-making designed to effect change.
• Conceptualize and execute non‑promotional education for multidisciplinary audiences (hematology, BMT/transplant, apheresis, transfusion medicine, genetic counseling, nursing), including webinars, symposia, workshops, and digital learning modules.
• Establish content measurement frameworks (reach, engagement, knowledge lift, practice intent) and continuous improvement loops.
• Provide operational management for Medical Affairs-led research, including RWE, HEOR, and ISR, including monitoring the contractual commitments of vendors and collaborators to ensure quality and timeline adherence.
• Ensure all evidence generation activities follow ICH-GCP guidelines, SOPs, and compliance requirements for post-marketing research.

Cross‑Functional Partnership

• Collaborate within Medical Affairs and with Clinical Development, Regulatory, Pharmacovigilance, Commercial, Market Access, and Patient Advocacy to ensure accuracy and balance across communications.
• Develop and deliver scientific training programs for internal teams (e.g., onboarding for MSLs/field medical; refresher modules on gene therapy mechanisms, safety monitoring, LTFU requirements)..

Associated Responsibilities:

• Own Med Affairs content as well as related SOPs and work processes.
• Ensure adherence to policies and procedures via audits.
• Develop and deliver monthly and quarterly updates to track progress and align on key priorities.
• Develop and manage department budget
• Lead or co‑lead medical review for scientific materials; partner with Legal/Compliance/Regulatory on clear SOPs and guardrails.

Qualifications:

• MD, PharmD, PhD in a biomedical field; experience in hematology or Oncology or cell and gene therapy strongly preferred.
• 8+ years in Medical Affairs/Scientific Communications within biopharma, including publication planning and medical education leadership.
• Understanding of hemoglobinopathies (SCD, β‑thalassemia), cell‑based gene therapy modalities, safety monitoring (including long‑term follow‑up), and registry/RWE experience is preferred
• Experience building omnichannel education programs.
• Fluency with compliance frameworks (GPP, ICMJE, ACCME, OIG, PhRMA Code) and medical review processes.
• Exceptional scientific writing, editorial judgment, and stakeholder management; comfortable engaging with KOLs, investigators, and advocacy leaders.

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:

• Northeast: As a Government Affairs Senior Manager, you will report directly to Axon’s Sr. Director of Government Affairs and work closely with internal and external stakeholders to support the team’s state and local legislative and regulatory, sales procurement, and grassroots advocacy efforts in the Northeast region (KY, WV, VA, MD, DE, PA, NJ, NY, CT, MA, VT, RI, NH, ME) . You will help drive Axon’s presence and position with state, city and county governments related to issues impacting the company, the sales team, and the industry. You will be a representative of Axon and lead meetings with state, city and county government officials to advance Axon’s position with relevant government and law enforcement stakeholders, as well as to drive broader awareness and support for Axon’s mission. In addition to the specific requirements listed below, the Senior Manager should be highly motivated, enjoy working in a fast-paced and often changing environment, have the ability to learn quickly, and be adept at setting priorities and anticipating needs.

What You’ll Do

Location: Northeast. Must be willing to travel 50%+ of time

• Assist in the development of strategic government affairs planning with a focus on supporting business development
• Monitor and assess state legislative and regulatory actions and initiatives
• Prepare position papers and project messaging points
• Lead meetings with elected officials, appointed officials, and government staffers
• Develop and maintain contacts with industry, elected officials and associations/third party groups
• Work closely with the sales team on assigned procurement opportunities
• Conduct research on local purchasing by-laws, council legislative process, and create purchasing process maps for city and county governments to support sales team efforts
• Assist in management of external government affairs consultants

What You Bring

• Minimum of 8 years combined full-time employment in city/county/state government and/or government relations firm
• Experience driving legislation
• Strong policy and analytical skills
• Experience multi-tasking and prioritizing work assignments under deadlines
• Excellent written and verbal communications skills, including the ability to synthesize complex information
• Recognized ability to work independently to drive assigned goals but also a team player to support the holistic needs of the department and the company
• A strong desire to continually improve and undertake new challenges
• A strong sense of accountability with high ethical standards
• Experience working with city, county, or state governments is a plus

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs

Benefits listed herein may vary depending on the nature of your employment and the location where you work

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

Job Title: Medical/Senior Medical Director, Clinical Development (Multiple openings)        

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.          

Role Overview: 

The Medical/Senior Medical Director of Clinical Development plays a key role in the execution and operational oversight of clinical trials, ensuring high-quality data generation to support the safety and efficacy of our pipeline products. This role involves supporting clinical study design, implementation, and data interpretation while working cross-functionally to align clinical activities with overall development plans. The Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives.

Key Responsibilities:

• Clinical Trial Design and Oversight:
  • Supports the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
  • Oversees the conduct of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines
  • Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug
  • Authors and contributes to clinical and non-clinical documents required during the clinical development process (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)
• Medical Expertise:
  • Provides medical expertise of the therapeutic area, disease state, and potential drug effects 
  • Reviews clinical data to identify and analyze safety concerns and adverse events, and makes appropriate recommendations to the team 
  • Stays current with relevant medical literature and clinical trial methodologies
  • Contributes medical expertise to external interactions with collaborators throughout the clinical development cycle  
• Cross-Functional Collaboration:
  • Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams to help ensure optimization of the clinical development process 
  • Presents clinical data to internal and external stakeholders
• Strategic Leadership:
• Contributes to the overall clinical development strategy
• Helps to identify critical clinical development milestones and helps the team to drive toward meeting or exceeding timelines
  • Leads the clinical contribution for clinical study reports, clinical documents and regulatory submissions
  • May oversee the work of Clinical Scientists working on the same or other programs

Qualifications:

• Medical degree (MD) with board certification in a relevant specialty
• Extensive experience in clinical research and development, ideally within the pharmaceutical industry
• Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements
• Excellent communication, leadership, and analytical skills 

 Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for the Medical Director is $255,00-288,000 and for the Senior Medical Director $306,000 to $343,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

About the Opportunity

We are seeking a highly skilled Machine Learning Scientist to drive the development and translation of cutting-edge ML models that have a direct impact on the care pathway for heart disease diagnosis and prognosis. In this role, you will collaborate with ML scientists, data engineers, biostatisticians, regulatory experts, and senior leadership to understand clinical requirements, develop innovative solutions, and support product development and regulatory approvals. You will also engage in high-impact research collaborations with world-renowned academic and medical institutions.

Responsibilities

• Research and develop state-of-the-art machine learning models for coronary CT angiography imaging applications.
• Conduct rigorous analysis and validation of machine learning algorithms and prototypes.
• Explore novel methods for processing and analyzing large, complex medical imaging datasets.
• Collaborate with engineering teams to deploy ML algorithms in clinical practice.
• Present research findings, insights, and recommendations to internal stakeholders and external collaborators.
• Author scientific publications and contribute to patent development.
• Manage collaborative research projects with leading academic partners.

Requirements

• Ph.D. in Computer Science, Data Science, Biomedical Engineering, Biomedical Imaging, or a related technical field; OR an M.S. with 5+ years of relevant experience.
• Strong theoretical and practical expertise in image science, applied mathematics, machine learning, and deep learning.
• Research experience in applying ML and deep learning techniques to medical image processing, including segmentation, registration, classification, reconstruction, and detection.
• Proven track record of publications in top-tier medical imaging or computer vision conferences and journals (e.g., MICCAI, IEEE TMI, CVPR, Medical Image Analysis).
• Proficiency in Python, with experience handling large datasets, implementing ML pipelines, and visualizing analysis results.
• Ability to translate complex clinical requirements into machine learning solutions.
• Strong critical thinking, problem-solving, and project management skills.
• Excellent interpersonal, cross-functional, and cross-cultural collaboration skills.

Preferred Qualifications: 

• 2+ years of postdoctoral research or industry experience.
• Hands-on experience in developing and applying advanced deep learning models, including vision transformers, semi-supervised/self-supervised/unsupervised learning, incremental learning, and continuous learning techniques.
• Strong domain knowledge in CT imaging and its clinical applications.

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $186,000 - $212,000
• TTC: $214,000 - $245,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

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!

Job Title: Clinical Trial Manager/Senior Clinical Trial Manager         

Location: Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required.  Remote may be considered.

About Us: 

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com

As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.  Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.  

Role Overview: 

Will ensure trial compliance, regulatory alignment, and operational efficiency while collaborating with cross-functional teams to advance Oruka's clinical pipeline.  Independently manage the clinical trial by effectively planning and executing the study to ensure quality of deliverables within the specified budget and timeframe. May serve as the clinical functional lead and lead clinical trial initiatives for Oruka's cutting-edge dermatology treatments.

Key Responsibilities: 

• Clinical Trial Management:
• Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets.
• Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence.
• Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and study reports.
• In partnership with Program Management, develop and drive cross functional study timelines related to trial setup and execution.
• Team Leadership:
• Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions.
• Successfully interface with Data Management, Biostatistics and Clinical Development to ensure seamless monitoring and data cleaning initiatives to meet study deliverables and timelines
• Foster a collaborative team environment focused on operational efficiency and continuous improvement.
• Regulatory and Compliance Oversight:
• Ensure that clinical trials are conducted in compliance with all applicable regulations, including FDA, EMA, and ICH-GCP guidelines.
• Support the preparation and submission of clinical trial applications, including INDs, NDAs, and other regulatory documents with functional leads.
• Manage interactions with Regulatory Affairs and external vendors to ensure timely submissions and approvals.
• Budget and Resource Management:
• Develop and manage clinical trial budgets, ensuring efficient use of resources and timely financial reporting.
• Monitor and control trial costs to ensure alignment with project forecasts and company objectives.
• Negotiate contracts and budgets with clinical vendors and investigators.
• Vendor and Site Management:
• Oversee the selection and management of clinical vendors (CROs, laboratories, etc.) and ensure they meet performance expectations.
• Develop strong relationships with clinical sites and external partners to ensure aggressive site startup, high-quality data collection and trial conduct.
• Perform risk assessment and management, addressing issues proactively to mitigate operational issues. 

Qualifications:

• Bachelor’s or Master’s degree in life sciences or a related field.
• 5-7+ years of experience in clinical operations, with a focus on managing complex clinical trials.
• Expertise in GCP and regulatory requirements.
• Strong leadership and team management skills. 

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for Manager level is $146,000 - $161,000 and Sr. Manager level is $161,000 - $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

Job Location:

• Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required.  Remote may be considered.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Job Title: Associate Director/Director, Analytical Development and Validation, Tech Ops (Biologics)         

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week. Remote may be considered.        

Role Overview:

The Associate Director/Director of Analytical Development and Validation will provide scientific and strategic leadership for late-stage analytical activities supporting the development, validation, and lifecycle management of biologic drug products, with a focus on monoclonal antibodies. This role will lead method validation and comparability efforts in support of BLA/MAA submissions, process changes, and commercial readiness, while partnering closely with CMC, Quality, Regulatory Affairs, and external partners.

The ideal candidate is a hands-on leader with deep expertise in analytical method validation, device functional testing, regulatory expectations for late-stage biologics, and the ability to guide teams through complex technical and compliance-driven milestones. This role is highly visible within the CMC team and a pivotal addition to our growing organization where you will play an integral role in supporting multiple programs’ analytical activities in support of releasing supplies for clinical trials and preparing for commercialization across US, Canada and EU.

Key Responsibilities: 

• Lead late-stage analytical development activities for biologics, including method validation, method qualification, and method transfer for release, stability, characterization and device functional testing assays.
• Provide subject matter expertise for ICH Q2/Q14, USP/EP/JP, and global regulatory expectations related to analytical methods.
• Oversee validation of assays including potency/bioassays, purity and impurities (SEC, CE-SDS, icIEF, HPLC), identity, characterization, residuals and device functional testing.
• Experience with PFS and Autoinjector functional testing is required, including validation per ISO guidance(s).
• Drive analytical strategies to support BLA/MAA submissions, post-approval changes, and comparability studies.
• Partner with Process Development, Manufacturing, Quality, and Regulatory to support late-stage development, tech transfer, and commercial launch readiness.
• Support analytical risk assessments, control strategy development, and lifecycle management
• Serve as analytical lead for regulatory interactions, including agency questions and inspections.
• Build, mentor, and lead a high-performing analytical development team (internal and/or external)
• Set technical direction, priorities, and timelines for late-stage analytical
• Manage and provide technical oversight to CDMOs and contract
• Review and approve protocols, validation reports, development reports, and regulatory
• 20-25% travel is required for this role.

Qualifications: 

• Experience with monoclonal antibodies and PFS/Auto Injectors is a
• Associate Director: Master’s (7+ years) or PhD (5+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC.
• Director: Master’s (10+ years) or PhD (7+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC.
• Relevant industry experience in method development, qualification, validation and method transfer in support of ongoing development and/or commercialization of biologics.
• Experience with methods including but not limited to U/HPLC, Capillary Electrophoresis, Spectrophotometer, Bioassay (ELISA and Cell-Based), device functional testing per ISO
• Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada and EU.
• Experience managing multiple stability studies, protocol development and performing trending analysis, OOS/OOT investigations, root cause analysis, etc.
• Experience with late-phase comparability studies, especially geared toward
• Experience in authoring/contributing to regulatory filings, specifically Module 3 for analytical methods and stability studies
• Demonstrated track record of successful tech transfers between CDMOs with an eye towards late-stage development and commercial launch.
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
• Must have a creative and strategic attitude with the ability to work in a fast-paced

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA is $182,000-208,000 for Associate Director and $213,000-240,000 for Director. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

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 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.

#LI-MK1

Job Title: Director, Clinical Quality Assurance

Location: Remote; Waltham, MA area candidates preferred. 

Role Overview:

The Director, Clinical Quality Assurance is responsible for providing strategic quality leadership, support, and oversight for Oruka’s clinical development activities, with primary focus on Good Clinical Practice (GCP) and related quality systems supporting clinical trials. This role will establish, improve, and lead phase-appropriate clinical quality processes, ensure robust oversight of clinical trial execution and vendor performance, and drive inspection readiness for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.

This role will partner closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure that clinical studies are conducted in accordance with GCP, applicable global regulations, internal procedures, and protocol requirements. The Director, Clinical QA will provide proactive quality input across the clinical trial lifecycle, support continuous improvement, and help build a quality-focused culture as the organization advances its pipeline.

 Key Responsibilities:

• Clinical Quality Oversight: Provide Clinical QA oversight for new and ongoing clinical studies to ensure compliance with GCP, applicable regulatory requirements, and internal procedures. Serve as the primary quality business partner to Clinical Operations and other development functions to identify, assess, and mitigate quality and compliance risks across the clinical trial lifecycle. Review key study-level documents for quality and compliance, including protocols, informed consent forms, investigator brochures, monitoring plans, vendor oversight plans, data review plans, study reports, and essential trial documentation. Support development and implementation of phase-appropriate clinical quality procedures and processes.
• Quality Systems Support for Clinical Development: Provide quality support for clinical deviations, protocol deviations, investigations, root cause analysis, CAPA development, effectiveness checks, and change control activities related to clinical development. Ensure appropriate escalation, documentation, trending, and management visibility for significant quality issues. Partner cross-functionally to identify recurring themes, systemic risks, and opportunities for process improvement. Establish and maintain clinical quality metrics and dashboards to support management review and continuous improvement.
• Vendor and CRO Quality Oversight: Provide quality oversight of CROs, central laboratories, clinical software vendors, and other GCP-relevant service providers supporting Oruka’s clinical programs. Support qualification, selection, ongoing oversight, and performance evaluation of GCP vendors, including participation in vendor audits or due diligence activities as needed. Contribute to vendor governance processes to ensure appropriate quality expectations, responsibilities, and issue escalation pathways are defined and maintained.
• Audit Program Execution: Develop and execute a phase-appropriate GCP audit strategy and annual audit program based on risk, program priorities, and business needs. Conduct and/or manage investigator site, vendor, study-specific, and for-cause audits as needed. Author audit plans, reports, observations, and follow-up actions, and ensure timely resolution of audit findings through appropriate CAPA management and verification of effectiveness. Travel to clinical sites, vendors, and investigator meetings as needed.
• Inspection Readiness and Health Authority Support: Lead GCP inspection readiness activities across the organization, including development of inspection readiness plans, mock inspections, storyboards, SME preparation, document review, and inspection response coordination. Serve as the primary Clinical QA lead for FDA BIMO inspection readiness and support for other global regulatory inspections involving clinical trial activities. Partner with internal teams and external vendors to ensure inspection-facing documentation, processes, and responsibilities are inspection-ready at all times.
• Risk-Based Quality Management: Embed risk-based quality management principles into study oversight and clinical quality processes. Partner with Clinical Operations and cross-functional teams to support quality risk assessments, critical data/process identification, quality tolerance considerations where appropriate, and evaluation of key risk indicators and centralized quality signals. Ensure quality oversight activities are focused on matters most relevant to subject safety, rights, data integrity, and trial reliability.
• Inspection-Ready Documentation and TMF Support: Provide quality support and oversight related to Trial Master File (TMF) health, inspection-ready documentation practices, and completeness of essential records. Collaborate with study teams and vendors to ensure that documentation standards, reconciliation processes, and issue escalation practices support an inspection-ready state throughout study conduct.

Minimum Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related discipline; advanced degree preferred.
• 10+ years of experience in Clinical QA/GCP Quality within biotechnology, pharmaceuticals, or a CRO environment.
• Strong knowledge of GCP and applicable global clinical regulatory requirements.
• Experience supporting quality oversight for Phase 1–3 clinical trials.
• Demonstrated experience with GCP audits, including investigator site and/or vendor audits.
• Experience supporting clinical deviations, investigations, CAPAs, and related quality system activities.
• Experience leading or supporting inspection readiness and regulatory inspections, including FDA BIMO inspections.
• Strong working knowledge of sponsor oversight expectations for CROs and other outsourced clinical vendors.
• Excellent judgment, communication, and collaboration skills, with the ability to influence across functions in a fast-paced environment.
• Willingness to travel as needed for audits, site visits, and inspection readiness activities (10-15%).

Preferred Qualifications:

• Experience as an early Clinical QA hire in a growing biotech company.
• Experience supporting biologics development programs.
• Familiarity with eQMS tools and clinical systems relevant to quality oversight.
• Experience with risk-based quality management and quality metrics.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates is $213,000 - $240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

 Job Location:

• Remote; Waltham, MA candidates preferred

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

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

Associate Director/Director, Scientific Communications, Cognito Therapeutics, Inc.

Location: Cambridge, MA, USA, Full-time

Company Description

Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX, IAG, Starbloom) late clinical stage company translating scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility data that showed our therapy’s strong safety profile and a notable preservation of cognition and function in patients with mild-to-moderate Alzheimer’s. We completed enrollment in our pivotal study, HOPE, in June 2025 and expect to release topline data from the trial in summer 2026. We are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world who are impacted by neurodegenerative conditions. With our patented brain stimulation technology, we are committed to developing convenient, safe and effective neuroprotective therapies to improve brain health and well-being for all.

About the Job

The Associate Director/Director, Scientific Communications will play a pivotal role in shaping and executing an integrated scientific communications strategy to support Cognito’s pipeline and future commercialization efforts. Reporting to the Head of Medical Affairs, this individual will be a key member of the Medical Affairs team, responsible for leading medical education initiatives, publication strategy, and support of the Brain Health Collaboratories.

This role is central to translating complex preclinical, clinical, and real-world data into clear, accurate, and compliant communications for both internal and external stakeholders, including healthcare professionals, payers, and scientific communities. The Director will ensure timely and effective dissemination of scientific data while aligning communications with congress activities and subject matter expert (SME) engagement strategies.

The position may be remote or hybrid (Cambridge, MA) and requires both strategic leadership and hands-on execution in a fast-paced, innovative environment.

Roles and Responsibilities

Strategic Leadership & Planning

• Develop and execute an integrated scientific and medical communications strategy aligned with corporate objectives and evolving standards of care.
• Define and lead publication planning, including identification of key data milestones, communication opportunities, and stakeholder alignment.
• Ensure seamless integration of communication plans with congress strategy and SME/KOL development.

Scientific Communications & Content Development

• Translate complex scientific and clinical data into clear, compelling, and compliant communications for diverse audiences.
• Lead the development of medical communication materials, including:
• Abstracts, posters, manuscripts, and presentations
• Unbranded disease state education materials (e.g., slide decks, training tools)
• Support data dissemination across multiple platforms and audiences.

Omnichannel Execution

• Implement omnichannel communication strategies to ensure consistent, effective delivery across digital, print, and live channels.
• Support and participate in scientific congresses, including presentation of data as appropriate.

Cross-Functional Collaboration & Stakeholder Engagement

• Serve as a central point of contact for scientific communications, coordinating with internal teams, external partners, and publication authors.
• Build and maintain strong relationships with key opinion leaders (KOLs), investigators, and professional societies, particularly in Alzheimer’s disease and related neurodegenerative disorders.
• Support advisory boards, roundtables, and scientific exchange initiatives to capture external insights and inform strategy.

Training & Internal Enablement

• Develop and deliver medical and scientific training for internal stakeholders, including commercial, clinical, and cross-functional teams.
• Ensure alignment and scientific rigor across all internal education initiatives.

Governance, Compliance & Operations

• Lead Medical (MLR) review processes, along with Legal, and Regulatory partners to ensure all materials meet compliance and scientific accuracy standards.
• Manage external vendors and agency partners supporting medical communications.
• Ensure adherence to regulatory, ethical, and company standards across all activities.

Qualifications & Experience

• Advanced degree in a relevant scientific or clinical discipline (MD, PhD, PharmD, or equivalent) preferred.
• 5+ years of experience in Scientific or Medical Communications within biotech, biopharma, or medical device industries; experience in neuroscience or neurodegeneration strongly preferred.
• Demonstrated ability to translate complex scientific data into clear, impactful narratives.
• Proven success in KOL engagement, publication strategy, and medical communications execution.
• Experience collaborating across functions and managing external partners, including academic institutions and vendors.
• Strong leadership, communication, and organizational skills; ability to thrive in a fast-paced, matrixed, and entrepreneurial environment.
• Willingness to travel (~15–20%) for scientific congresses and internal meetings.

What You’ll Do:

This Senior Scientist will support ongoing activities for drug product formulation and manufacturing with external partners and CDMOs. This would include manufacturing process development and optimization, clinical supply manufacture, and commercial preparedness with a focus on oral solid dosage forms. The individual will have a working knowledge of drug product development through all stages of clinical development.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Support technology transfer, formulation, and process development, optimization, scale-up, and manufacturing of clinical supplies, acting as Kailera’s person-in-plant for activities critical to program success
• Collaborate closely with internal cross-functional teams, including Drug Substance, Analytical Development, Supply Chain, Clinical, Quality Assurance, and Regulatory Affairs to ensure seamless progression of projects
• Review master batch records and executed batch records to ensure product quality
• Author change controls, review specifications, change notifications, and manage manufacturing deviations as necessary, working closely with Kailera’s quality group
• Present formulation development and manufacturing updates to internal and external stakeholders periodically
• Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND, IMPD, and NDA)

Required Qualifications:

• 5+ years of experience in solid-oral dosage form development. Technical expertise in unit operations common to solid oral dosage form (e.g., milling, wet/dry granulation, compression, and film-coating)
• Extensive experience with management of day-to-day activities at CDMO’s
• Strong troubleshooting skills with the ability to quickly provide input in a fast-paced environment
• Strong working knowledge of Microsoft suites and common scientific software
• Experience with design of experiment (JMP/Minitab)
• Experience using quality systems such as Veeva to author and approve documents
• Excellent verbal, written, and interpersonal skills
• Ability to travel up to 10-20% (domestic and international)

Preferred Qualifications:

• Experience in the GLP-1 space, late-stage development

Education:

• B.S. and 12+ years of experience, advanced degree with 10+ years, or a PhD with 5-8 years of experience
• Degree in Engineering, Pharmaceutical Sciences, Chemistry or closely related field

ESSENTIAL JOB FUNCTIONS:

• Leads the planning and execution of a complex, global clinical trial from start-up through close-out, in compliance with regulations/SOPs, within budget and timelines.
• Provides oversight and guidance to clinical operations personnel assigned to the clinical trial.
• Partners closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and other functions to ensure aligned and efficient trial execution.
• Establishes strong relationships with investigators and KOLs.
• Contributes to the development and review of key study documents including protocols, ICFs, monitoring plans, EDC specifications and statistical analysis plans.
• Contributes to the selection of vendors and CROs. Manages and oversees CROs, vendors, and other external partners to ensure high-quality performance and adherence to expectations.
• Develops, manages, and tracks clinical trial budgets, ensuring studies are delivered within approved financial parameters.
• Provides regular, clear updates on study status, risks, and milestones to senior leadership and key stakeholders.
• Proactively identifies operational risks and implements mitigation strategies to maintain timelines, quality, and compliance.
• Supports and facilitates execution of contracts, clinical trial agreements, and study budgets.
• Direct manager of approximately 1-2 direct reports.
• Provides expert input into the building of department infrastructure, including developing, training, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
• Drives the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
• Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.
• Complete other duties as assigned by the manager.

JOB SPECIFICATIONS:

• Bachelor’s degree in science/healthcare field, a nursing degree, or equivalent combined education.
• 10+ years of strong hands-on experience leading large, complex Phase 3 clinical trials preferably in oncology/hematology in US, Asia, Europe; or equivalent combination of training and experience.
• Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
• In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Ability to work independently and collaboratively in a fast-paced, matrixed, 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 verbal and written communication skills.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Flexibility to travel domestically and internationally as required.
• Experience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions.
• Experience setting up clinical trials outside of US and Europe is a plus.
• Field monitoring and/or clinical data management experience preferred.
• Proficiency with Microsoft Project

The base range for a Director is $228,000 - $252,000 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

Who We Are:

Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing. 

The Role: 

Cogent Biosciences is preparing for its first commercial launch and we are seeking a motivated self-starter Director, IT Business Partner for Commercial, Medical Affairs and Corporate Applications. You will be a strategic and tactical technology leader, partnering closely with cross-functional business leaders and teams to document and execute on Commercial, Medical Affairs and Corporate Applications technology roadmap. This is a hands-on role and you will partner with the business leaders and teams to support multiple existing and new system implementations in a fast paced environment.

This role will report to the Vice President of Information Technology. This position is a hybrid position and the candidate should be located near our Waltham MA office.

Responsibilities:

What You’ll Do:

We are seeking an experienced, highly motivated Medical Director, Clinical Development to join our growing team. This individual will play a pivotal role in designing and executing clinical development programs that advance our pipeline of innovative therapeutics. The successful candidate will bring strong clinical insight, a deep understanding of drug development in a biotech setting, and a proven ability to work cross-functionally in a dynamic, fast-paced environment.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Responsible for medical monitoring/reporting and safety activities
• Provide medical leadership in the design, planning, and execution of clinical development strategies across multiple studies
• Acts as the medical contact at the company for clinical/medical issues
• Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel
• Serve as the medical expert for assigned assets studies
• Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages
• Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution
• Oversee and support data interpretation, analysis, and clinical study reports
• Work closely with internal stakeholders, including Regulatory, Safety, CMC, Medical Affairs, and Translational Science teams
• Partner with external collaborators, KOLs, CROs, and investigators
• Support scientific publications, conference presentations, and other external communications
• Participate in safety review meetings and provide clinical input into adverse event evaluation and reporting

Required Qualifications:

• 3+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
• Hands-on experience designing and executing clinical trials
• Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring
• Excellent written and verbal communication skills, including protocol and regulatory document writing
• Demonstrated ability to engage with KOLs, investigators, and cross-functional teams
• Can work independently, self-starter attitude
• Advanced PowerPoint skills; working knowledge of Excel and other commonly used clinical systems/tools
• Ability to manage multiple studies and deadlines in a fast-paced environment
• Must be exceptionally detail oriented

Preferred Qualifications:

• Experience in cardiometabolic therapeutic area is advantageous
• Proven track record of contributing to IND submissions and global regulatory filings is a strong plus

Education:

• MD or equivalent is required

Company Overview:

Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.

Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits.

Today, Strand has established multiple programmable mRNA platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX-001, is currently being evaluated in a Phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts.

Become the next standout single strand!

Job Summary:

Strand is looking to build a team that understands the value of working at a start-up.  Joining Strand now places you alongside the founding executive team and world-leading advisors. We are looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team.  This opportunity will offer the employee the ability to work closely with the founding team and be a part of the growth strategy of the company.

We are looking for a highly motivated and enthusiastic leader for the role of Vice President of Clinical Development Operations. Reporting to the Chief Medical Officer, the Vice President of Clinical Development Operations will lead all clinical trial activities and operations for the organization. This individual will drive all trial activities for our 2 clinical stage programs as well as support the planning and development of other company programs as they advance throughout pre-clinical development into first-in-human clinical trials. This will also be an opportunity to work closely with various cross functional teams internally and externally to prepare for regulatory interactions and drive the development of our programs forward. 

Primary Responsibilities:

• Serve as the clinical operations expert for all clinical stage and preclinical stage programs for the company. 
• Accountable for delivery of assigned clinical program/trial budgets, managing study timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
• Develop clinical timelines, budget forecasts and ensure accountability for tracking and deliverables.
• Develop and maintain departmental resource and budget plans.
• Ensures oversight and study-specific Risk Management Plans (RMP) (e.g., milestones, metrics, and critical path), ensuring appropriate escalation when required. Evaluate study-level issues for broader impact (e.g., cross-study, cross-program etc.) and ensure resolution
• Partner and collaborate with cross-functional stakeholders, external consultants, and other relevant stakeholders
• Lead and oversee execution of clinical trials in compliance with ICH/GCP, local regulations, and Strand Therapeutics’ SOPs to ensure quality and data integrity
• Support the selection, oversight, and management of CROs and other vendors including financial aspects of the partnerships.
• Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team.
• Develops site recruitment, enrollment, and engagement strategies for all clinical trials
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
• Manage and provide oversight to the cross functional teams and CRO/vendor(s) related to all aspects of clinical trial operations
• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures. Manages content, agenda, and discussions at clinical operations sub-teams and ensures action items are closed
• Along with other Clinical Development personnel, represent Strand Therapeutics externally to Investigators, site staff, and Key Opinion Leaders
• Perform and document study level Sponsor Oversight of outsourced clinical activities
• Communicate study-status, cost, and issues to ensure timely decision-making by senior management
• Oversee/collaborate with Clinical Quality Assurance on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
• Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Strand Therapeutics
• Provide oversight and mentorship to assigned Clinical Operations staff by providing clinical operations/functional area expertise and support identification and prioritization of study and program level work. Will have direct line management of Clinical Operations staff.
• Strive for continuous improvement and more efficient ways of working in clinical operations
• Supervise Clinical Operations Team (CTMs, CRAs, CTAs, etc.) and ensure team member’s adherence to the regulatory requirements, ICH-GCP guidelines, and other relevant procedures.
• Participate in the design, development and review of clinical trial protocols and study-specific documents, e.g., informed consent forms, study guidelines, operations manuals, oversight plans, process developments (including Trial RACI).
• Keep up to date with industry practice and communicate key messages back to Strand Therapeutics, providing recommendation accordingly.

Qualifications:

• 15+ years of clinical trial operations experience in biotech; Experience working in a smaller, fast paced environment highly preferred with 5+ in management or leadership roles.
• Experience running oncology trials required.
• Experience in and understanding of end-to-end management of clinical trial conduct, the pharmaceutical industry, clinical drug development, clinical trials operations and regulatory components is essential.
• Experience with all aspects of clinical trial management including streamlining operational activities of trial protocols and ensuring deliverables are attained in a timely manner. 
• Proven success participating in cross-departmental clinical strategy, planning and implementation activities. (Departments include executive leadership, regulatory, QA, CMC, translational development, program management, finance, business development, medical affairs and medical writing).
• Extensive experience with the identification, negotiation, management, and oversight of external vendor partnerships, such as CROs, for monitoring, database management, statistics, and safety reporting. 
• Experience building an internal clinical program management function, managing a team of employees and consultants as well as hiring internal stakeholders to support trial needs and leveraging external consultants as needed. 
• Experience with regulatory submissions, including INDs, NDAs and BLAs highly preferred. 
• Experience interacting with domestic health authorities, such as the FDA, required; Experience interacting with global regulatory health authorities, such as the EMA, PMDA, and/or Australian CTN is a plus. 
• Strong interpersonal skills with the ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization. 
• Strong organizational and time management skills. 

Strand offers a fast-paced, entrepreneurial, team-focused small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet Strand’s goals. 

Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates.

Job Type: Full-time

Salary: $316,000 - $356,000 annually plus bonus and equity incentives 

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure, as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. 

Purpose / Summary:

Reporting to the Head of Regulatory Affairs CMC, the Director, Global Regulatory Affairs – CMC is responsible for owning and leading the global CMC regulatory strategy and execution to enable clinical development, commercialization, and lifecycle management of the company’s products. This individual ensures that global CMC regulatory requirements are proactively identified, strategically addressed, and fully integrated into development and commercial plans.

The Director serves as the single-point CMC regulatory lead for assigned programs, accountable for regulatory strategy, health authority engagement, submission quality, and inspection readiness. This role requires close collaboration with senior leadership and cross-functional stakeholders to define regulatory objectives, manage risk, and support timely, high-quality global submissions and approvals.

Essential Functions:

• Lead and own the global CMC regulatory strategy for assigned programs across development, registration, and lifecycle management, identifying key risks, remediation activities, and opportunities for acceleration while ensuring approvability and inspection readiness.
• Serve as the regulatory CMC representative on internal CMC teams, core submission teams, and cross-functional governance forums, providing authoritative regulatory input and decision-making support.
• Provide strategic global Regulatory Affairs–CMC guidance to project teams and ensure timely development and execution of integrated regulatory project plans.
• Assess, interpret, and communicate global CMC regulatory requirements to ensure all development and commercial activities comply with applicable regulations, guidelines, and regional expectations.
• Initiate, lead, and strategically manage interactions with global health authorities (FDA, EMA, PMDA, and other national competent authorities) to obtain alignment on CMC strategy, negotiate data requirements, resolve issues, and support timely approvals.
• Lead preparation of high-quality CMC briefing packages and regulatory narratives for health authority meetings, including definition of regulatory positions, risk mitigation strategies, and alignment of supporting data; participate in or lead agency interactions as a key spokesperson.
• Provide strategic regulatory leadership for GMP inspections and PAI readiness, including inspection preparation, response strategy, and alignment of regulatory commitments with Quality and Tech Ops execution.
• Coordinate, review, and be accountable for the quality and timeliness of global CMC regulatory submissions and lifecycle filings, including original INDs, CMC amendments, IMPD amendments, annual reports, meeting requests, briefing packages, marketing applications, and post-approval changes.
• Work directly with external contractors and collaborators, managing regulatory deliverables, communication pathways, and project plans to ensure accuracy, compliance, and executional success.
• Establish and lead CMC regulatory governance for assigned programs, including defining review cadence, risk escalation pathways, and communication of status, risks, and decisions to senior leadership and executive management.
• Remain current on evolving global regulations, standards, policies, and guidance issued by relevant regulatory authorities and assess impact to development and commercial programs.
• Partner with cross-functional stakeholders to proactively identify, escalate, and resolve CMC regulatory issues impacting development timelines or approval readiness.

Requirements:

• Bachelor’s degree in a scientific discipline such as Biology, Chemistry, or Pharmaceutical Sciences; advanced degree preferred.
• Minimum of 10 years of progressively increasing responsibility in CMC Regulatory Affairs within the biopharmaceutical industry.
• Demonstrated experience leading successful global marketing application submissions and approvals.
• Proven experience preparing CMC sections of global clinical trial applications (IND, IMPD, CTA).
• Experience with drug-device combination products preferred.
• Demonstrated ability to develop and defend CMC regulatory strategies supporting new product development, commercialization, and lifecycle management.
• Strong track record of successful global regulatory interactions and submissions for biologics, innovative medicines, and/or combination products in the US, EU, and other regions.
• Demonstrated ability to provide risk-based regulatory decision-making and strategic recommendations to senior leadership.
• Strong leadership, communication, and interpersonal skills with the ability to influence decision-making diplomatically across functions.
• Ability to work independently and effectively within matrixed, cross-functional teams and with external partners.
• Excellent written and verbal communication, organizational, and project management skills.
• Ability to operate in a fast-paced environment while managing multiple priorities.

Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Ironwood currently anticipates that the initial base salary for this position could range from between $208,000K - $243,600K. The actual base salary will depend, in part, on the successful candidate’s qualifications for the role, including education and experience.  Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.

#LI-Hybrid

Who We Are:

Cogent Biosciences is a publicly traded biotechnology company dedicated to developing precision therapies for genetically defined diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease and offer meaningful hope to patient's.

The company’s lead therapeutic candidate, bezuclastinib, is a highly selective tyrosine kinase inhibitor designed to potently target KIT D816V and other mutations in KIT exon 17. These mutations are known drivers of systemic mastocytosis (SM) and advanced gastrointestinal stromal tumors (GIST) - both serious conditions driven by oncogenic KIT signaling. Bezuclastinib is currently being evaluated in multiple registration-directed trials across Non-Advanced SM (NonAdvSM), Advanced SM (AdvSM), and GIST.  In July 2025, Cogent announced that its registration-direct SUMMIT trial in patients with NonAdvSM achieved statistical significance across all primary and key secondary endpoints, and the company is on track to file its first New Drug Application for this patient population by the end of 2025.  The company also remains on track to announce top-line results for its APEX trial in patients with AdvSM in the second half of 2025 and for its PEAK trial in patients with GIST by the end of 2025.  The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor, and the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting other serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.

Through its commitment to precision medicine and targeted innovation, Cogent Biosciences is working to transform the treatment landscape for patients with serious and underserved diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease. Our culture of inquisitiveness fuels continuous learning and innovation; we challenge assumptions, ask bold questions, and embrace a mindset of discovery to uncover transformative insights.

The Role: