Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Job Summary:

As a key member of the cross-functional Development Team responsible for providing regulatory writing expertise and leadership to formulate the writing strategy for key regulatory documents for submission. The Sr. Director, Head of Regulatory & Medical Writing will be responsible for providing guidance to the medical and or regulatory writing group (contractors and internal writers) assigned to deliverables and ensuring appropriate work allocation and document preparation.; will also provide review and substantive editing of documents to ensure delivery of high-quality documents. This individual will work effectively with many other functional groups, including with Clinical Scientist(s), Medical Monitors, Regulatory and other functions as applicable, and collaborate with clinical medical writing as applicable to ensure scientific excellence in the execution of clinical trials. The Head of Regulatory Writing will build a medical writing group internally when appropriate.

Reporting to the SVP, Head of Regulatory Affairs, this role will be responsible for the regulatory writing & medical writing deliverables of assigned project(s), in accordance with the agreed timelines and quality standards.

Responsibilities:

• Ensure appropriate allocation of internal and external resources needed for all regulatory writing deliverables.
• Hire and manage medical writers internally and manage external medical writing contractors.
• Forecasting and maintaining budget for the regulatory writing team.
• Assess efficiencies, help identify areas of improvement and initiate improvement processes.
• Coordinate, author and edit documents used to support clinical trial conduct and reporting including but not limited to:
• Clinical study protocols and clinical protocol amendments (in partnership with Clinical Science/Clinical Development)
• Clinical study reports
• Investigator’s brochures and annual updates
• IND submissions and annual reports
• Lay-person summary
• Integrated summary reports
• Clinical, Nonclinical and Multidisciplinary Information Amendments
• NDA, BLA, MAA, (e)CTD submissions
• Risk Management Plans
• Health Authority responses
• Briefing Documents, ODDs, BTDs/PRIME, FTD etc
• Participate in relevant subteam(s) and ensure effective planning and management of timelines for all components of assigned documents across all projects.
• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
• Support and develop deliverables required for global transparency and disclosure requirements (e.g., plain language lay summary, applicable redactions to regulatory documents subject to EU posting regulations and results for EU CTR).Partner with Biometrics in developing standard TFLs and in text tables for deliverables as applicable
• Maintain and support developing and reviewing standard processes and templates.
• Review and edit documents as required.
• Work effectively and lead in cross-functional working groups.

Qualifications:

• Candidates must have a BS with 15+ years, or MS or other advanced science degree (e.g.: RN, NP, MSN, PharmD, PhD, MD) with 10+ years of experience in oncology clinical research experience as a clinical or regulatory medical writer within the pharmaceutical/biotech industry.
• Prior experience leading a regulatory writing group
• Experience writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA).
• Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, document management systems.
• Familiarity with all phases of drug development processes (discovery to market), clinical study protocol design, CTA/IND submissions, investigator’s brochures and clinical study data collection and results reporting.
• Advanced knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• Experience writing, at a minimum, protocols (Phase 1-3, in oncology), investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses. Experience with Pediatric Investigational Plans (PIPs) is preferred.
• Advanced understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
• Ability to interpret and summarize complex tabular and graphical data presentations.
• Strong organization, documentation and communication skills with an ability to multitask.
• Adaptable / flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).

Position Title:  

Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Job Summary:

Nurix Therapeutics, Inc. is seeking a Manager/Sr. Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) to join the Regulatory team.  The successful candidate will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products for guiding and executing upon regulatory strategy of compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. This includes supporting regulatory activities to enable clinical development plans and studies, working cross-functionally across the organization.

Responsibilities:

• Provides regulatory strategic direction and support for assigned global development programs/development program activities
• Assists Sr. Regulatory Affairs staff with their development program activities and deliverables
• Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management
• Acts as regulatory representative on early and/or late phase clinical studies, ensuring compliant execution of trials
• Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
• Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities
• Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications
• Assist in the cataloging and maintenance of regulatory application submissions
• Conduct research and stay up-to-date on regulatory requirements and changes
• Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle
• Monitor and assess regulatory risks and develop mitigation strategies
• Oversee quality assurance processes to ensure compliance with regulatory standards
• Review SOPs pertaining to Regulatory
• Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
• Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
• Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
• Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
• Participates in cross-functional process initiatives impacting regulatory submission processes and systems
• Manages consultants and contractors as needed

Experience and Skills:

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
• Must have minimum of 8 years in Regulatory affairs strategy
• Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
• Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
• Ability to read, analyze and interpret scientific and technical information, as well as regulatory
• Ability to understand and explain detailed regulatory affairs and compliance programs and/or to effectively present information to senior regulatory management, other departments or external
• Ability to comply with changing regulatory
• Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
• Strong project management and critical thinking skills
• Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
• Excellent organizational and communication skills, both written and verbal
• Ability to work independently as well as part of a team environment
• Positive attitude, energetic and proactive
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Strong interpersonal skills and the ability to effectively work with others

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).

Company Overview

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

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

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

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

Summary 

We are seeking a Central Operations Head (COH) to provide strategic leadership across clinical drug supply, Clinical Trial Agreement (CTA), and eTMF management to support global clinical development programs. This role partners cross-functionally with Clinical, Regulatory, Legal, Technical Operations, and Operational Excellence to ensure alignment on trial needs, risk management, and execution priorities.

You will oversee end-to-end delivery across trials, define outsourcing and vendor strategies, and ensure performance through KPIs, KRIs, and governance. This role is accountable for driving operational excellence, ensuring inspection readiness, and maintaining compliance with global regulations and internal standards.

As a leader, you will build and develop a high-performing team, establish scalable processes and best practices, and foster a culture of accountability, innovation, and continuous improvement in a fast-paced biotech environment.

Your role

• Provide strategic direction for clinical drug supply management, clinical trial agreement (CTA) management, and eTMF management activities to support clinical development objectives across all programs and trials
• Collaborate with Trial Management, Regulatory Affairs, Clinical Development, Legal, and Technical Operations to align on trial needs and deliverables
• Collaborate with Operational Excellence & Clinical Compliance and GMP compliance to align on risk assessment, metrics, KPIs, and KRIs for management of clinical drug supply, CTAs, and eTMF
• Define and implement outsourcing strategies (incl. Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs) and vendors) in partnership with VP of Global Clinical Operations and Head of Clinical Sourcing & Contracting
• Define functional goals, performance metrics, and resourcing strategies. Drive innovation including adoption of risk-based approaches
• Oversee end-to-end execution of drug supply-/ CTA-/ and eTMF management across clinical trials, ensuring timely, high-quality, and inspection-ready deliverables
• Track CRO, CMO, and vendor performance using metrics, KPIs, and KRIs; lead SMO governance meetings to address escalated issues and drive continuous improvement
• Establish and maintain best practices and standards throughout the trial lifecycle
• Ensure adherence to global regulatory requirements, GCP and internal SOPs. Lead audit and inspection readiness for drug supply-/ CTA-/ and eTMF management and implement effective oversight models for internal teams and outsourced partners. Perform internal quality reviews and ensure inspection readiness of trial documentation
• Lead, coach, and develop a high-performing team. Foster a culture of collaboration, continuous learning, and accountability, while supporting career progression and succession planning across the function
• Select, manage, and govern external vendors. Define expectations, monitor performance via KPIs, and drive accountability through governance forums to ensure quality, timelines, and cost-effectiveness

What You Bring

• 12+ years of trial management experience with 5+ years in leadership position
• Bachelor’s degree in Life Sciences, Pharmacy or related field (required). Advanced degree, e.g., MS, PharmD, PhD, MBA (preferred)
• Significant experience working in global clinical development organization
• Significant experience in outsourcing and oversight
• Expert knowledge in ICH GCP and GMP
• Expert knowledge in computer technologies to plan, forecast, and track documents/ material on all levels
• Expert knowledge in risk assessment and management on program and trial-level
• Familiarity with clinical trial systems (e.g., CTMS, eTMF, IRT) and operational metrics, KPIs, and KRIs
• Familiarity with clinical supply planning, forecasting, and inventory tools
• Independent judgment and objectivity
• Strong analytical and influencing skills
• Ability to drive accountability across functions
• Strong leadership and interpersonal skills

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

#LI-Hybrid

About this Role

Our pharmaceutical team is looking for a highly motivated and creative Director of Chemistry, Manufacturing and Control (CMC) to lead expansion and growth of partner pharma activities toward clinical production. This role will be responsible for all CMC activities across the external drug development pipeline of Varda’s partners. Reporting to the VP, Pharma Program Management), this position requires collaboration across multiple departments and external partners to design, develop, and implement novel approaches to manufacture drug products in low Earth orbit. This is an opportunity in an exciting area of growth for Varda, the role will shape Varda’s product culture and will play a significant role in establishing the low Earth orbit economy. The ideal candidate must create and lead the CMC development team for drug products from early stage through clinical manufacturing.

Responsibilities

• Develop and lead all GMP CMC-related activities (biologics and small molecule) including process chemistry, drug product, analytical, and formulation from lead optimization phase through to clinical development and commercialization  
• Build and lead internal GMP CMC team with functions around process development, quality control, and quality assurance. 
• Manage external drug product manufacturing service providers and API supply chains to support clinical trial development  
• Collaborate with Varda pharma R&D teams to understand future CMC needs and handle internal tech transfers 
• Author all CMC sections of regulatory filings including FDA, EMA and other national authorities to support the conduct of clinical trials 
• Act as subject matter expert for non-clinical CMC to both preclinical and clinical development teams, interact with all internal and external stakeholders to support CMC needs 
• Ensure high-quality standards, develop SOPs, implement GMP compliance and QC/QA 
• Monitor progress and regularly report to the C-suite team 
• Manage and monitor the CMC timelines and budget 

Basic Qualifications

• 8+ years of CMC leadership experience advancing drug product development programs to successful clinical trials 
• B.S. or M.S. in life sciences such as Chemistry, Biochemistry, or related fields 
• Firm understanding of cGMP and FDA regulatory guidelines as they pertain to CMC 

Preferred Skills and Experience

• 12+ years of CMC leadership experience advancing drug product development programs to successful clinical trials 
• PhD in life sciences such as Chemistry, Biochemistry, or related fields 
• Documented evidence of prior successful CMC project leadership from early phase, late phase leading to clinical trials. 
• Experience in leading and direct management of research, analytical laboratories, process development, and manufacturing 
• Advanced understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas 
• Command of global CMC-related regulatory requirements and guidelines 
• Excellent leadership, managerial and communications skills in a cross functional environment 
• Hands-on experience in managing multiple internal and external stakeholders (e.g. working with CMOs on managing drug product development) 
• Experience with writing CMC sections for regulatory filings and knowledge of current regulations in US and EU 
• Fluent communication in English, written and verbal 

Pay Range

• Salary range: $200,000 - $230,000/per year
• This role is on-site in El Segundo, CA
• Leveling and base salary is determined by job-related skills, education level, experience level, and job performance
• You will be eligible for incentives in the form of stock options and/or long-term cash awards

Company Overview

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

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

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

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

Summary 

We are seeking a Site Management Leader (SML) to oversee all site management and monitoring activities conducted by the CRO in a clinical trial. This role will be assigned to critical clinical trials of the Tango portfolio and serve as the primary contact between sponsor and CRO for site management aspects.

In a fast-paced, small biotech environment, the SML will operationally oversee and manage the end-to-end site management activities as per approved timelines, budget, regulatory requirements, and internal standards. This individual will play a key role in the execution and delivery of clinical trial objectives.

The ideal candidate is highly collaborative, detail-oriented, and comfortable operating in a hands-on environment, with a focus on building scalable processes, tools, and best practices to support efficient and compliant clinical trial execution.

Your role

• Serve as the primary liaison between CTT and CRO for all site management activities
• Oversee CRO performance for site management to ensure compliance with contractual obligations, timelines, and quality standards
• Lead or contribute to the development of the Site Management Oversight Plan and other trial-specific operational plans in collaboration with CTT
• Contribute to the development of a site-related RBQM framework to drive efficiency and ensure quality of critical site management aspects
• Identify trial-level risks and contribute to the development and implementation of risk management and mitigation strategies
• Manage and monitor site identification, feasibility assessments, and site selection processes
• Ensure site readiness for initiation, including training, documentation, and logistical preparedness
• Oversee and support site initiation visits (SIVs) and ensure timely site activation
• Monitor patient recruitment strategies and enrollment progress across clinical sites
• Ensure protocol compliance and data integrity through oversight of site monitoring activities
• Review monitoring visit reports and ensure timely resolution of site issues and follow-up actions
• Collaborate with CRO to address site-level issues. Escalate unresolved issues to CTL and CTT, as needed
• Ensure adherence to ICH GCP, regulatory requirements, and internal SOPs throughout trial conduct
• Participate in audits, inspections, and quality assurance activities related to site management
• Oversee site closure activities and ensure proper documentation and archiving

What You Bring

• 5+ years of trial management experience with 3+ years in site management. Leadership experience (preferred)
• Bachelor’s degree in Life Sciences, Pharmacy or related field
• Experience working in global clinical development organization
• Experience in Oncology development (preferred)
• Knowledge of ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines
• Knowledge of trial/ site risk assessment and management
• Direct experience with site health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred)
• Experience in outsourcing and oversight
• Familiarity with clinical trial systems (e.g., CTMS, eTMF, EDC, IRT, eCOA) and operational metrics, KPIs, and KRIs
• Strong vendor management and project management skills
• Leadership skills with the ability to lead cross-functional teams
• Strong interpersonal and communication skills
• Strong analytical thinking and decision-making capabilities
• Willingness to travel, as required (typically 10 – 20%)

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

#LI-Hybrid

What You'll Do

We’re looking for a Contracts Counsel to lead drafting, review, and negotiation of a broad range of agreements. You’ll be a primary legal partner to several business teams, helping scale contracting processes, accelerate deal cycles, and manage risk with practical, business-friendly guidance.

Responsibilities

• Independently draft, review, and negotiate a wide variety of agreements, including master services agreements, statements of work, clinical trial agreements, consulting agreements, quality agreements, NDAs, SaaS/technology agreements, data processing/security addenda, and other vendor/commercial and/or research contracts
• Serve as day-to-day counsel to affiliates and cross-functional stakeholders (e.g., Procurement, Finance, Clinical, Quality, IT/Security, HR, and business teams), advising on contract structure, risk allocation, and negotiation strategy
• Triage contract requests and drive matters through intake, approvals, execution, and repository/CLM workflows; keep deals moving while maintaining consistency with company policies
• Identify and manage key issues (indemnities, limitation of liability, IP ownership/licensing, confidentiality, data privacy/security, insurance, termination, audit rights, subcontracting, compliance)
• Partner with InfoSec/Privacy and other SMEs to align contractual obligations with internal controls (e.g., security requirements, incident response, vendor assessments)
• Act as a strategic stakeholder in the development of processes, systems, and training to support contract lifecycle management
• Develop and maintain templates, fallback positions, playbooks, and process guidance; proactively spot patterns and reduce repeat friction in negotiations
• Support governance, audits, and reporting on contracting volume, cycle times, and risk trends; help train internal teams on contracting best practices
• Coordinate with outside counsel as needed and manage scope/costs

Where You'll Work

This is a hybrid role with in-office collaboration 2x per week in our San Francisco and/or Palo Alto Offices.

Who You Are

• J.D. from an accredited law school and active bar membership in at least one U.S. jurisdiction
• 4–6 years of relevant experience, including at least 2 years at a law firm, with substantial hands-on responsibility negotiating commercial contracts
• Preferred experience in life sciences/biotech/pharma and/or other regulated industries
• Have strong drafting/redlining skills and proven ability to manage negotiations independently
• Have willingness to use and incorporate AI tools on a routine basis
• Organized, responsive, and comfortable managing multiple priorities in a fast-paced environment
• Experience with contracts in the life sciences industry, such as sponsored research and clinical trial agreements
• Experience building contracting infrastructure (templates, playbooks, CLM workflows and tools) and partnering closely with Procurement

Seeking talent near: Princeton, NJ

Position Summary

The Associate Director, Drug Product Development is responsible for the formulation, primary package, and manufacturing process development for Acadia’s growing portfolio of drug candidates at all stages of development, and will provide technical oversight, expertise and guidance of externalized drug product development related activities. The scope includes development of formulations, package, and process for all modes of administration including oral solid, liquid, and injectable dosage forms for candidates ranging from clinical development to process validation and life cycle management. The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues and implementation of new manufacturing process technology for products intended for clinical and commercial distribution. The role will be critical in ensuring that we optimize development, reduce risk and accelerate the development of new assets for commercialization.

Primary Responsibilities

• Designs and develops pharmaceutical formulations and manufacturing processes to support clinical trials, registration and product launch.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, scale up, and commercialization of the new drug candidates in the Acadia pipeline.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development, scale-up to manufacturing of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• Review the clinical supply requirements with the clinical supply managers and plan requisite manufacturing schedule with the CSPs to ensure uninterrupted supply of clinical trial materials.
• Perform risk assessments of manufacturing process and product at key development milestones and address the findings with the relevant CSPs.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with analytical, manufacturing, quality assurance and regulatory counterparts to develop plans and protocols for drug product development and for life cycle management of the established products.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Assist the CSPs in preparation for health authority inspections and for pre-approval inspections.
• Other responsibilities as assigned.

Education and Experience

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.
• A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.
• Demonstrated success in the field of formulations and dosage form development.  
• Experience authoring technical reports and CMC sections for regulatory filings. 

Must possess:

• Comprehensive understanding of the dosage form formulation and package development, manufacturing process development, scale-up, optimization and validation processes.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel domestically and internationally.

#LI-HYBRID #NC1

Company Overview

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

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

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

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

Summary

In this new role, reporting to the Vice President, Biometrics you will be working with cross‑functional clinical teams responsible for statistical activities across Tango’s clinical programs, including overseeing statistical deliverables outsourced to clinical CROs. This is an exciting opportunity to make an impact in the development of transformative therapies that may change patients’ lives. You will be a good communicator, collaborative, self-motivated, and forward‑thinking.

Your Role:

• You will serve as a biostatistics expert for Tango’s clinical programs
• Provide strategic input to optimize trial designs in early phase dose escalation studies and late phase registrational studies
• As a biostatistics representative, proactively collaborate with internal and external CRO team members to coordinate the planning and execution of statistical deliverables
• Conduct statistical modeling to enable robust and efficient statistical designs and address identified or potential statistical issues arising with studies
• Contribute to clinical protocol development, including authoring or review of the Statistics section and reviewing of other sections by applying statistical principles
• Author or review the development of statistical analysis plans for clinical trials and oversee the development of tables, figures, and listings, and associated deliverables
• Review electronic case report form (eCRF) designs to ensure data collection meets the requirements of statistical analyses
• Provide statistical input for clinical documents
• Perform QC/QA of statistical deliverables including validation of key analysis results
• Perform ad hoc statistical analyses as needed
• Contribute to clinical study reports, including authoring of statistical methods, and interpretation of study results
• Accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions; provide thorough review for required components of regulatory submissions including appropriate datasets, define files, reviewer's guides, and other relevant documents
• Address statistical questions/comments from FDA and other regulatory agencies, or IRB/ECs
• Support and contribute to the preparation of publications, including manuscripts, posters, and oral presentations
• Lead standardization and process improvement efforts for Biostatistics function, and contribute to cross-functional process improvement efforts including the definition of biostatics templates and standards
• Represent Tango regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners
• Support inspection readiness activities as needed
• Develop and maintain advanced competencies in statistical methodology and advanced trial designs, particularly in oncology drug development
• Additional duties and responsibilities as required

What You Bring:

• PhD in statistics or related discipline; MS with appropriate years of directly relevant experience
• At least 10 years’ experience in the pharmaceutical or biotech industry
• Oncology experience required
• Experience in the design, analysis, and reporting of clinical trials
• Experience in INDs, NDAs, MAAs, or other regulatory submissions
• In-depth knowledge of statistical methods for clinical trials
• Knowledge of FDA, EMA, and ICH regulations and guidelines
• Proficient in statistical programming (SAS and R)
• Ability to lead statistical efforts for multiple studies
• Fluent in data standards, including SDTM and ADaM
• Experience in outsourced statistical services provided by CROs
• Ability to work independently and act with initiative to address issues
• Excellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner

#LI-hybrid

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

ABOUT THE ROLE 

As a Field Marketing Manager, you will be the face of OLIPOP in your region, driving grassroots awareness and trial through local guerrilla marketing efforts, event activations, and in-store sampling programs. This role requires a dynamic, entrepreneurial mindset and strong leadership skills to supervise a team of Brand Ambassadors and execute high-impact marketing initiatives that connect national strategy with local execution. 

Location: Los Angeles, CA. Ability to travel within the LA Metro area as needed (up to 1–2 hours). Approximately 45 minutes from LAX International Airport. 

This role requires a strong local presence, with an average of 4 days per week committed to in-market activities in these regions. 

RESPONSIBILITIES 

Local Marketing & Sampling 

• Plan and execute guerrilla sampling programs to drive brand awareness and trial.
• Build relationships with local businesses, influencers, and event organizers to maximize impact.
• Adapt national marketing campaigns for local audiences. 

Event Activation & Sponsorships 

• Coordinate OLIPOP presence at major events (e.g., festivals, marathons, trade shows).
• Negotiate sponsorships and evaluate strategic fit for events—consider frequency, ROI, and unique consumer segments to ensure differentiation and maximize impact.
• Manage logistics: permits, staffing, product delivery, and on-site setup (including tents and equipment). 

Brand Ambassador Team Management 

• Recruit, train, and oversee part-time Brand Ambassadors.
• Ensure compliance with brand guidelines and sampling protocols.
• Track ambassador hours, performance, and KPIs. 

Cross-Functional Collaboration 

• Partner with Sales on account activations, blitzes, and merchandising.
• Work closely with Marketing to report on localized campaigns and consumer insights. 

Budget & Reporting 

• Track budgets for sampling and events; report on performance metrics.
• Identify creative opportunities to reach new consumer profiles. 

QUALIFICATIONS 

• 2–5 years in field and sales marketing, event marketing, and brand ambassador management (beverage experience preferred).
• Strong organizational skills; ability to manage multiple projects.
• Proven ability to work independently in a fast-paced, remote environment.
• Excellent interpersonal and communication skills.
• Proficiency in KPI tracking and reporting.
• Clean driving record; background check required for leased vehicle use.
• Creative and resourceful in identifying local marketing opportunities.
• Results-driven with a proactive, problem-solving mindset.
• Sales experience or mindset is a plus.  

Travel & Physical Requirements 

• Frequent travel within region; occasional overnight stays (approx. 6-8 nights/month).
• Comfortable working nights, weekends, and holidays for events.
• Ability to lift and transport event materials (up to 50 lbs). 

Driving Requirements 

• Must be comfortable driving a Sprinter van as part of the role.
• Prior experience driving larger vehicles (e.g., Sprinter vans, box trucks, or similar) strongly preferred.
• Valid driver’s license required

REPORTS TO: Director, Field Marketing 

COMPENSATION: $95,000-$120,000 base salary + bonus 

About Avalyn

Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA-IPF, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.

Position Overview

The Associate Director of SEC Reporting & Technical Accounting will build and lead Avalyn’s external reporting and SOX compliance capabilities as a newly public biotechnology company. This high-impact, foundational position is ideal for a technically strong, pragmatic leader who enjoys creating structure in a dynamic, mission-driven environment. The Director will establish scalable SEC reporting processes, design and document internal controls over financial reporting, and serve as the Company’s subject matter expert on complex accounting matters. Reporting to the VP of Finance, this role partners closely with Finance and cross-functional teams across the organization to drive alignment, accountability, and best practices through strong collaboration and clear communication.

SEC Reporting

• Lead the preparation and timely filing of SEC reports, including Forms 10-K, 10-Q, 8-K, and S-8, and oversee XBRL tagging and related external reporting processes.
• Own the preparation and review of financial statements, footnotes, and MD&A, ensuring compliance with U.S. GAAP and SEC regulations.
• Partner with Legal, FP&A, Investor Relations, and senior leadership on earnings releases, proxy materials, and other public disclosures.

Technical Accounting

• Serve as the company’s subject matter expert on technical accounting matters, including revenue recognition, collaboration and licensing arrangements, R&D activities, financing transactions, and stock-based compensation under ASC 718.
• Research, evaluate, and document accounting conclusions for complex transactions and prepare technical accounting memoranda and policy documentation.
• Support commercialization readiness by helping establish GAAP- and SOX-compliant revenue accounting and order-to-cash processes in partnership with Commercial, Market Access, Finance, and IT.

SOX Compliance & Internal Controls

• Design and implement internal controls over financial reporting as the company continues to build toward full SOX compliance.
• Lead walkthroughs, risk assessments, control documentation, and remediation efforts in partnership with process owners and external consultants.
• Strengthen scalable controls and operating processes across SEC reporting, technical accounting, and equity administration.

Equity Accounting & Administration

• Lead equity accounting, including the calculation and recording of stock-based compensation in accordance with ASC 718.
• Oversee external support for day-to-day stock administration activities and help ensure strong governance around equity-related processes.
• Support Section 16 reporting and related compliance requirements in coordination with legal counsel.

External Audits

• Manage quarterly reviews and annual audits and serve as the primary liaison with external auditors on technical accounting matters.
• Coordinate PBC requests and support an efficient, well-organized audit process.

Qualifications

• A minimum of a Bachelor’s degree in Accounting or Finance required; CPA required.
• 8-10+ years of progressive accounting experience, including substantial SEC reporting and technical accounting experience in a public company environment.
• Big 4 or national public accounting firm experience strongly preferred.
• Demonstrated experience building or enhancing SOX compliance programs.
• Experience in biotechnology, life sciences, or other R&D-intensive industries strongly preferred; experience with cell therapy revenue recognition is a plus.
• Deep knowledge of U.S. GAAP and SEC regulations, including revenue recognition, equity compensation, and complex transaction accounting.
• Experience with tools such as Active Disclosure, Equity Edge, NetSuite, or similar systems preferred.
• Strong communication, sound judgment, and the ability to lead through influence in a fast-paced, mission-driven environment.

The role:

The Vice President of Biometrics will provide strategic and operational leadership across statistical activities as the company transitions into Phase III clinical trials. This role will be responsible for defining and executing the integrated biometrics strategy, overseeing CRO and vendor partnerships, ensuring data integrity and regulatory readiness, and serving as a key leader on the clinical development team. The ideal candidate brings deep late-stage expertise, strong cross-functional leadership, and a hands-on mindset well suited for a lean, fast-growing biotech organization.

Key responsibilities:

• Provide strategic leadership for biometrics across all clinical development programs, with primary focus on Phase III execution
• Define and implement an integrated biometrics strategy supporting clinical trial design, data quality, statistical analysis, and regulatory submissions
• Serve as a core member of the clinical leadership team, partnering closely with Clinical Operations, Data Management, Regulatory Affairs, Safety, and Medical Affairs
• Lead and oversee CROs and external vendors responsible for biostatistics statistical programming and related biometrics activities.
• Oversee development and review of key deliverables including SAPs, DMPs, CRFs, TFL shells, interim analyses, database locks, and clinical study reports
• Ensure data integrity, statistical rigor, and compliance with GCP, ICH, and global regulatory requirements
• Provide strategic input into study design, endpoint selection, sample size calculations, and adaptive or innovative trial methodologies as appropriate
• Support regulatory interactions and submissions, including briefing documents, responses to health authority questions, and advisory committee preparations
• Establish scalable biometrics processes, standards, and SOPs to support late-stage development and future pipeline growth
• Build, mentor, and lead internal biostatistics capabilities over time, as appropriate to company growth

Required experience & skills:

• Bachelor’s degree or advanced degree, ideally in biostatistics, statistics, mathematics, or a related quantitative discipline
• Minimum of 12 years of progressive experience in biostatistics within the biotechnology or pharmaceutical industry
• Significant experience leading biostatistics activities for Phase III clinical trials and regulatory submissions
• Demonstrated success managing CROs and external vendors in a late-stage development environment
• Proven track record as a strategic biometrics leader, contributing substantively to complex study designs, endpoint development, and statistical strategy across global development programs; able to provide sharp, on-your-feet thinking in real-time discussions with regulators, KOLs, and cross-functional teams, while maintaining a roll-up-your-sleeves approach to engage directly with protocols, analysis plans, and data when needed.
• Strong understanding of global regulatory expectations related to clinical data, statistical analyses, and inspection readiness
• Proven ability to operate strategically while remaining hands-on in a lean organization
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude

Preferred experience & skills:

• Prior experience serving as a functional or biometrics lead in regulatory interactions with FDA and ex-U.S. health authorities
• Experience in cardiovascular, rare disease, or genetically driven conditions
• Background in small or mid-sized biotech companies transitioning into late-stage development
• Experience building or scaling internal biometrics functions and infrastructure
• Familiarity with innovative trial designs and modern statistical methodologies

Base Salary Range: $300K - $375K

Legend Biotech is seeking an Executive Director, Pipeline Clinical Lead as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Pipeline Clinical Lead is a senior clinical development leader accountable for the scientific and medical direction of early stage clinical programs. This role provides strategic and operational leadership across first in human through proof of concept studies, with accountability for clinical strategy, trial design, execution, interpretation, and regulatory interactions.

The Pipeline Clinical Lead will lead and develop a team of physicians and scientists, work closely with cross functional partners, and collaborate with external development partners and investigators. Deep expertise in clinical trial design, regulatory frameworks, and compliance in drug development—ideally within cell therapy—is essential.

This role requires strong scientific judgment, leadership presence, and a hands on approach in a fast paced, entrepreneurial environment, with a clear focus on patient safety and clinical impact.

Key Responsibilities

Clinical Development Leadership

• Serve as clinical science lead for early stage programs (pre IND through Phase 1/2), including study design, execution, data interpretation, and reporting.
• Define and integrate clinical strategies, including PK/PD, biomarkers, diagnostics, and translational approaches, particularly for cell and gene therapies.
• Provide clinical input into asset selection, review of preclinical data, and development path decisions.

Regulatory & Compliance

• Lead or support IND preparation and amendments, clinical sections of regulatory submissions, and responses to health authority questions.
• Represent the clinical function in pre IND, IND, and (as applicable) BLA/MAA interactions with regulatory agencies.
• Champion patient safety, ethical conduct, and compliance with GCP, corporate policies, and global healthcare regulations.

Cross Functional & External Collaboration

• Partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, Early Discovery,
• Manufacturing, Biomarkers, and Pharmacovigilance to ensure integrated program delivery.
• Collaborate with external development partners, academic investigators, KOLs, and study sites.
• Act as a credible scientific and clinical representative for programs in internal governance and external forums.

People & Matrix Leadership

• Provide direct line management and mentorship for Medical Directors, Clinical Research Scientists, Medical Writing, Clinical Program management and other clinical staff as applicable.
• Lead effectively in a matrix environment, anticipating cross functional needs and proactively resolving conflicts or risks.
• Contribute clinical leadership to business development, due diligence, and partnership activities when required.

Requirements

• MD or MD PhD (or equivalent) with US board certification or international equivalent.
• ≥8 years of clinical development experience in industry and/or academia, with demonstrated leadership in hematology/oncology.
• Proven experience designing and executing clinical trials from first in human through registrational stages.
• Prior involvement with IND submissions; experience with BLA/MAA filings and health authority meetings strongly preferred.
• Cell therapy and/or CAR T clinical development experience highly desirable IT Skills.
• Strong scientific judgment with the ability to navigate complex clinical and regulatory challenges.
• Demonstrated ability to lead cross functional and geographically distributed teams in a matrix environment.
• Excellent written and oral communication skills, including protocol writing, regulatory documents, publications, and senior level presentations.
• Highly collaborative, influential leader with the ability to represent programs with credibility and confidence.
• Hands on, execution oriented mindset with strong organizational and analytical skills.
• Willingness to travel up to 15–20%.

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About the Opportunity

We are seeking a highly skilled and experienced Clinical Trial Liaison to join our team. The ideal candidate will have a minimum of 3 years of experience in clinical research, a background in nursing or other healthcare fields, and a proven track record in patient recruitment. This role will involve working closely with clinical sites to ensure the smooth execution of clinical trials, with a particular focus on cardiovascular and/or imaging studies. As a key point of contact between study sites and the sponsor, the Clinical Trial Liaison will be responsible for fostering strong relationships, ensuring protocol compliance, and supporting patient recruitment and retention efforts.

Responsibilities

• Serve as the primary liaison between the clinical trial sponsor and participating sites, ensuring effective communication and collaboration.

• Support clinical sites in meeting patient recruitment goals by providing guidance on strategies, tools, and resources.

• Monitor site performance and provide proactive support to resolve any issues related to protocol compliance, patient recruitment, and data collection.

• Ensure that all site staff are trained and compliant with study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements.

• Collaborate with site staff to identify and overcome barriers to patient recruitment and retention.

• Track site progress and prepare reports on site performance, recruitment metrics, and study milestones.

• Conduct regular site visits, both remote and in-person, to provide hands-on support and address any operational challenges.

• Work closely with cross-functional teams, including project management, 
• regulatory affairs, and data management, to ensure seamless study execution.
• Maintain a thorough understanding of cardiovascular disease, study protocols, and the specific needs of the patient population

Requirements 

• Bachelor’s degree in healthcare related field; 
• Minimum of 3 years of experience in clinical research, with a focus on site management and patient recruitment.

• Experience working in cardiovascular and/or imaging clinical trials is highly desirable.
• Strong knowledge of clinical trial protocols, GCP guidelines, and regulatory requirements.

• Proven ability to work independently and manage multiple clinical sites at the same time.

• Excellent communication, organizational, and problem-solving skills.
• Ability to build strong relationships with site staff and foster a collaborative working environment.
• Flexibility to travel as required for site visits and meetings, travel up to 50% of time. 

Preferred Qualifications

• Advanced degree in nursing, clinical research, or a related field.
• Experience working with diverse patient populations in cardiovascular studies.

• Certification in clinical research (e.g., CCRP, ACRP, SOCRA) is a plus

Compensation

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 10% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $100,000 - $116,000
• TTC: $110,000 - $127,600 

*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.

Company: 

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.   

For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA. 

We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture! 

Position: 

The Clinical Trial Specialist (CTS) is primarily responsible for the coordination of activities associated with the setup and management of clinical studies under the direction of, or as delegated by a member of the Global Clinical Operations team. Responsibilities will range from clinical study coordination to data entry projects and general office work. This position will report to the Sr. Director of Clinical Operations.

Responsibilities include: 

• Help provide accurate and up-to-date study status information to the organization.
• Implement accurate tracking systems, forms, and other relevant documents to support clinical studies
• Assist the clinical operations team with vendor management, including tracking all study invoices and payments
• Assist in the preparation of spreadsheets, presentations, etc. utilizing Microsoft Office Suite
• Assist in the periodic review and QC of eTMFs to support inspection readiness and archiving of completed studies
• Maintain electronic files of clinical trial documents for ongoing projects
• Coordinate logistics for clinical operations team meetings, kick-off meetings, etc. Prepare draft minutes from the various meetings for review and finalization
• Assist in the tracking of clinical lab samples for multiple clinical trials, including tracking shipments of samples from lab vendors and helping maintain documentation of reconciliation practices and follow up any outstanding items

Education, Experience, and Skills: 

Required:

• Science or nursing degree, BA, BS, RN, or higher or equivalent combination of education and experience in Biotech or Pharmaceutical industry sectors
• 0 -2 years of experience as a Clinical Trial Assistant or Clinical Study Coordinator
• Knowledge of ICH GCPs is a plus
• Proficient with MS Word, Excel, and PowerPoint
• Strong interpersonal, communication (written and verbal)
• Excellent organizational skills
• Ability to work as part of a multi-functional study team
• Based in the San Francisco Bay Area

Salary Range: $93,500 - $97,700

Location: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area. 

Benefits: 

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• Shuttle service from BART, CalTrain and the Ferry.
• Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits. 

Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect. 

Legend Biotech is seeking a Sr. Manager, Clinical Trial Operations Planning & Analytics as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Sr. Manager, Clinical Trial Operations Planning & Analytics is responsible for the strategic planning and analytics capability to support current and future Legend pipeline studies. This role will establish scalable approaches for feasibility, site identification, study startup planning, forecasting, and trial performance analytics to improve predictability and enable earlier operational intervention. The position partners closely with Clinical Operations leadership and cross-functional stakeholders to determine and assess assumptions, refine strategy, and translate data into actionable operational decisions across the study lifecycle.

Key Responsibilities

• Lead development of standardized frameworks, tools, and processes for feasibility, site identification, enrollment forecasting, study startup planning, and predictive trial performance modeling across pipeline studies.
• Develop data-driven approaches to identify the right countries and sites globally to support activation and enrollment acceleration and to predict key operational outcomes such as startup timing, enrollment, and study completion.
• Build scenario models and planning outputs to support base and best case operational strategies and contingency planning.
• Establish contingency planning triggers, risk indicators, and escalation thresholds based on modeled performance risk.
• Partner with study teams, CROs, and cross-functional stakeholders to pressure-test trial assumptions and refine country and site strategies.
• Create and maintain dashboards and analytics to monitor startup, activation, enrollment, and delivery risk trends.
• Translate study and portfolio performance data into actionable insights and executive-ready recommendations for senior leadership.
• Support continuous refresh of assumptions as study conditions, portfolio priorities, and external dynamics evolve.
• Capture lessons learned and convert them into reusable planning tools, templates, and methodologies that improve cross-study consistency.
• Represent the function in internal planning discussions and external partner interactions related to feasibility, forecasting, and performance analytics.
• Performs other duties as required.
• Works closely with the Sr. Director and VP of Clinical Operations. Clinical Operations Capabilities & Scalability and collaborates with Clinical Operations study teams, Clinical Development, IT, ITQA Biostatistics, Regulatory, Project Management, Procurement, Finance, QA, and CRO/vendor.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific, health care, data, or related discipline. Advanced degree preferred.
• 7+ years of pharmaceutical, biotech, CRO, or related clinical research experience; 10+ years preferred.
• Experience working with data sources to inform trial forecast modeling
• Experience in clinical operations planning, feasibility, study startup, operational analytics, or related functions required.
• Experience supporting global site identification, country strategy, or enrollment planning strongly preferred.
• Experience building dashboards, models, or analytics to support clinical trial execution preferred.
• Oncology, cell therapy, or early-phase clinical development experience preferred.
• Ability to travel as necessary (approximately 10%).
• Knowledge/familiarity with tools to enable trial forecasting and modeling.
• Strong critical thinking, analytical, strategic planning, and problem-solving skills.
• Effective oral, written, and interpersonal communication skills with strong presentation capability.
• Forward and critical thinker with ability to translate data into decisions.
• Strong organizational and project management skills and the ability to multitask.
• Computer literacy required (MS Word, MS Excel, MS PowerPoint, MS Project, and analytics/visualization tools).
• Working knowledge of GCP, FDA, and ICH Guidelines.

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Legend Biotech is seeking a Senior Clinical Trial Associate (Contractor)  as part of the Clinical Operations team based Remotely.

Role Overview

We are seeking a highly skilled and motivated Senior Clinical Trial Associate (Sr. CTA) to join our growing Clinical Operations team to support early-stage clinical development. The Sr. CTA will play a critical role in the execution of complex Phase I/II CAR-T oncology clinical trials by providing high-quality operational, administrative, and coordination support.
The ideal candidate will have substantial experience in clinical trial operations and administration, with a strong understanding of clinical trial processes, regulatory requirements, and GCP. This role is critical to ensuring the efficient execution of clinical trials, maintaining regulatory compliance, and providing operational support to cross-functional study teams.

Key Responsibilities

Clinical Trial Operations Support

• Provide cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study-related forums.
• Support Senior Clinical Trial Managers in the day-to-day execution of complex Phase I and Phase II CAR-T oncology trials, ensuring all activities are conducted in compliance with ICH-GCP and applicable regulatory requirements.

Documentation & TMF Management

• Oversee the preparation, organization, and maintenance of trial documentation, including regulatory files, Trial Master Files (TMFs/eTMFs), and study correspondence.
• Ensure documentation is current, complete, and compliant with ICH-GCP and company SOPs.

End-to-End Trial Coordination

•  Assist with the planning, start-up, execution, and close-out of clinical trials, including coordination with clinical sites and support of protocol and regulatory compliance activities.

Regulatory & Compliance Support

• Assist with the preparation, submission, and tracking of regulatory and IRB/IEC documents.
• Maintain working knowledge of applicable regulations and standards to support ongoing study compliance.

Meeting & Communication Coordination

• Schedule and coordinate study meetings, including investigator meetings, site visits, and internal team meetings.
• Prepare meeting agendas, document minutes, track action items, and follow up to ensure timely completion.

Tracking, Reporting & Data Support

• Assist in tracking trial progress, including site activation, enrollment, monitoring activities, and key study milestones.
• Prepare and maintain study status reports and trackers for internal and external stakeholders.
• Support data management activities, including query tracking and data reconciliation, in collaboration with Data Management.

Site & Vendor Support

• Serve as a key liaison between the clinical trial team, vendors, CROs, and investigational sites to ensure clear and timely communication.
• Assist with vendor oversight by tracking deliverables, timelines, and resolving operational issues.

Problem Solving & Continuous Improvement

• Proactively identify operational issues and risks, propose solutions, and escalate to the Senior Clinical Trial Manager or Clinical Operations leadership as appropriate.
• Contribute to the development and continuous improvement of clinical operations processes and best practices.

Training & Mentorship

• Provide guidance and mentorship to junior CTAs, sharing best practices and contributing to team capability building.

Requirements

• Bachelor’s degree in life sciences, clinical research, or a related field.
• Relevant certifications (e.g., CRC, CRA) are a plus.
• Minimum of 3–5 years of experience as a Clinical Trial Associate or in a similar clinical research role.
• Demonstrated experience supporting trial coordination, regulatory documentation, and site management activities.
• Oncology trial experience required; cell therapy and/or CAR-T experience strongly preferred.
• Strong understanding of ICH-GCP, regulatory requirements, and clinical trial processes.
• Proficiency with CTMS, eTMF, and EDC systems.
• Excellent organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Strong written and verbal communication skills.
• Detail-oriented with strong analytical and problem-solving skills.
• Ability to work independently and collaboratively within cross-functional teams.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with eTMF and EDC platforms.

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Legend Biotech is seeking a Sr. Director, R&D Finance FP&A and Portfolio as part of the Finance team based in Bridgewater, NJ.

Role Overview

A key member in the Pipeline Finance team, serving as the dedicated financial partner for the Pipeline functions, leading Finance Analyst in Data Management, Reporting and Dashboarding, and Analytics support senior management decision making. Based in the US, this role reports directly to our CFO.

This role will take charge of end-to-end financial planning, budgeting, forecasting and analysis work in the R&D field, support the establishment and optimization of a standardized FP&A system, provide professional financial support for the implementation of R&D strategies, optimal allocation of resources and investment decisions, collaborate effectively with cross-functional teams, and ensure that the R&D financial FP&A work is aligned with the overall financial strategy of Legend and Pipeline BU.

It translates Pipeline strategy into actionable plans for Pipeline projects, provides tailored financial analysis, budgeting and forecasting, and collaborates with Pipeline leadership, other FP&A colleagues and Pipeline Finance Analysts to ensure financial alignment and data-driven decisions.

The Ideal candidate should have pharmaceutical/biotech FP&A experience with RD familiarity, strong strategic thinking, data analysis and independent work abilities. Must be US-based, able to collaborate cross-functionally in a matrix environment, and support RD Finance strategy execution.

The ideal candidate will have a strong track record of driving improved financial performance, enhancing productivity, strengthening internal controls, and advancing systems and processes. Success requires high learning agility, the ability to collaborate across diverse and geographically dispersed teams, and skill navigating a complex, matrixed environment.
Strong leadership is essential to support business decision-making and ensure smart resource allocation across the R&D pipeline.

Key Responsibilities

Strategy & Portfolio Financial Leadership

• Support RD Finance Head in defining the financial strategy for Pipeline BU, as well as the overall development portfolio, including resource allocation across the pipeline.
• Align Pipeline Finance strategy with Pipeline needs, support FP&A process optimization and standardize best practices across projects and therapeutic areas.
• Provide strategic financial input into the Pipeline Strategy and business plan, enhancing transparency of cost, value, and return on investment.

FP&A Execution & Budget Management

• Develop operating plans and budgets that support timely and high-quality delivery of business objectives, including benchmarking and tracking efficiency improvements.
• Take charge of budget preparation, review, consolidation and variance analysis, ensuring alignment with R&D strategy and Pipeline priorities.
• Regularly report budget execution, forecast deviations and performance to the RD Finance Head with targeted insights.

Consolidation, Analytics, Financial Analysis & Decision Support

• Leading RD Finance consolidation, data management, reporting and analytics.
• Conduct RD-focused financial analysis (cost, ROI, resource efficiency) and apply advanced financial skills to address early development uncertainty.
• Partner with Pipeline leadership team to support project prioritization, resource allocation and investment decisions, maximizing portfolio value.
• Track Pipeline financial KPIs, establish performance measurement frameworks, analyze deviations and propose improvement measures to drive continuous improvement.
• Ensure high-quality financial evaluations for investment decisions and prepare robust financial materials for Senior Executive Team review.

Cost Control & Compliance

• Manage budget execution, warn of risks, coordinate corrective actions and control costs to ensure operational plans remain within established budgets.
• Identify cost optimization opportunities and support implementation to enhance resource utilization efficiency.
• Maintain accountability for SOX and FCF controls, ensure FP&A compliance with Finance Standards, policies and relevant global clinical trial accounting policies.

Collaboration & Process Enhancement

• Collaborate with the Pipeline team to understand business needs and resolve financial collaboration issues.
• Coordinate with other FP&A colleagues and RD Finance Analysts for data/report support, aligning ways of working.
• Identify and support partnership opportunities and external collaborations to enable portfolio growth.
• Develop and optimize FP&A processes that effectively support evolving R&D and Pipeline business needs, contributing to global policy/program implementation

Requirements

• Bachelor's degree in Finance, Accounting, Business Administration, or a related field. MBA, CPA, or CMA is a plus.
• 15+ years of progressive FP&A experience, preferably in the biotech/pharmaceutical industry, with specific experience supporting R&D functions.
• Demonstrates expertise in financial modeling, budgeting, and forecasting.
• Advanced proficiency in Excel (Pivot tables, macros, data modeling).
• Expertise in Anaplan (as the SME) and familiarity with ERP systems (e.g., SAP).
• Experience with data visualization tools (e.g., Tableau, Power BI).

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Legend Biotech is seeking a Sr. Medical Director/Executive Director, Early Clinical Development as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Sr. Medical Director/Executive Director of Early Clinical Development is a critical role in the company with significant impact on the development and life cycle of drug development projects. The candidate for this role will be responsible to lead the Early Clinical Development Team, for IND submission and the design, execution and oversight of first-in-human, dose finding clinical trials. Full understanding of tenets of FIH studies (e.g. dose selection rationale, biomarker plans, etc.) and the relevant compliance framework for clinical development activities are essential. Candidate must possess passion for science and patients, as well as entrepreneurial drive to help the organization succeed.

Key Responsibilities

• Lead clinical science aspects of design, execution, interpretation and reporting of early (first in human) stage clinical trials.
• Collaborate with scientists and technical experts to integrate cellular therapy specific aspects of PK/PD, diagnostic, and biomarker plans into the overall clinical development strategy.
• Contribute clinical leadership and expertise in the development of study protocols and clinical study reports, study medical monitoring, safety reporting, regulatory documentation and interactions, and other clinical deliverables.
• Collaborate with academic scientists, clinical experts, and study investigators.
• Represent and advocate for the project in internal and external venues.
• Clinical leadership for business development and partnership activities as needed.
• Act as a champion for high standards of compliance, ethics and safety, and putting patients first.

Requirements

• MD or MD-PhD or equivalent medical degree with US board certification in hematology and/or oncology.
• 3+ (Senior) / 6+ (Executive) years’ industry/ academic clinical development experience in hematology/oncology, leading cross-functional development teams is required.
• Sub-specialization and/or clinical development experience in cell therapies or CAR-T is highly desirable.
• Experience in biotech - preferred but not required.
• Demonstrated capacity to think creatively when addressing complex situations
• Demonstrated excellence and experience in first-in-human clinical development including the design, execution of first in human trial, and submission of INDs.
• Experience leading pre-IND and IND meetings with health authorities is highly desirable.
• Excellent communication and leadership skills; willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment; stellar writing skills, a track record of publications; superb presentation skills
• Able to anticipate biometrics, regulatory, clinical operations, development sciences, pharmacovigilance, and other development needs to ensure successful program delivery
• Ability to communicate effectively with cross functional teams such as pre-clinical scientists, clinical operations, safety-PV, biomarker, biostatistics, regulatory, and project management including peer to peer interactions with academic scientific experts, KOLs and stake holders.
• Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the team work
• Ensures compliance with corporate policies and procedures, as well as, all related healthcare laws and regulations
• Highly collaborative & effective influencing skills and the ability to operate across multiple geographies
• Strong track record of delivering results through effective team and peer leadership in matrix
• Superior interpersonal skills, & communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence. Communicate regularly and effectively with senior leaders.
• Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating medical/clinical information into clinical development strategies.
• Travel requirement up to 15-20 % of the time.

The advertised pay range covers both levels of this position.

Here's the base pay range by level:

Sr. Medical Director, Early Clinical Development- $294,483 - $386,511

Executive Medical Director, Early Clinical Development- $338,656- $444,486

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Legend Biotech is seeking a Legal Operations Manager, Contracts & Privacy as part of the Legal team based in Bridgewater, NJ.

Role Overview

The Legal Operations Manager, Contracts & Privacy supports the Legal Department by managing day-to-day contract lifecycle administration, coordinating operational aspects of the company’s Global Privacy program and assisting with legal operations processes and tools. This role is highly execution-oriented and works closely with attorneys and cross-functional partners to ensure efficient, compliant, and well-organized legal workflows in a fast-paced biotech environment. The position will coordinate closely with Legend Biotech’s Chief Privacy Officer and reports to Legend Biotech’s Deputy General Counsel.

Key Responsibilities

Contract Lifecycle Administration

• Coordinate the end-to-end contract process, including intake, routing, approvals, execution, and filing
• Maintain and update contract records in the company’s CLM system, ensuring accuracy and completeness of data
• Ensure contracts comply with company standards, regulatory requirements, and approval processes
• Populate basic contract template agreements (e.g. NDAs, consulting agreements, etc.)
• Track contract status, key dates (e.g., expirations, renewals), and obligations
• Assist in maintaining contract templates, standard forms and clause libraries
• Respond to internal inquiries regarding contract status and process
• Perform other contracts-related activities and tasks as assigned

Privacy Program Support

• Support day-to-day operations of the company’s Global Privacy program
• Assist with privacy impact assessments, security risk assessments and other privacy reviews and documentation
• Maintain records related to data processing activities and ensure compliance with data subject right requests
• Help coordinate privacy training, awareness initiatives and policy updates
• Track and escalate privacy-related issues and requests to appropriate stakeholders
• Organize and coordinate privacy champions meetings to ensure privacy requirements are understood and implemented
• Coordinate implementation of data mapping plan to maintain up to data inventory, liaising with system/business owners, and assist with other EU GDPR operational matters
• Track key privacy metrics (e.g., breaches report, PIAs conducted, DSARs received)
• Assist with clinical trial privacy matters, including informed consent (ICF) updates, investigator/HCP notice, and related matters

Legal Operations Support

• Maintain organized legal files, databases, and corporate records
• Support subsidiary management across US & EU jurisdictions
• Support reporting efforts by compiling basic KPIs, metrics and data for the Legal Team
• Assist with invoice processing and vendor onboarding as needed
• Support implementation and ongoing management of legal systems and tools

Requirements

• Bachelor’s degree or equivalent experience required
• 4+ years of experience in legal coordination, contract administration, paralegal support or legal operations
• Experience with contract management systems or similar tools strongly preferred
• Basic familiarity with data privacy concepts and regulations (e.g., GDPR, CCPA, HIPAA) is a plus
• Strong organizational and administrative skills with high attention to detail and accuracy
• Ability to manage multiple tasks and deadlines effectively
• Effective communication and responsiveness
• Ability to follow established processes and identify opportunities for improvement
• Comfort working with systems, data and cross-functional teams

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Legend Biotech is seeking a Senior Clinical Research Scientist as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Clinical Research Scientist (CS) in Clinical Development is an important role in the company supporting the development and life cycle of drug development projects. The Clinical Research Scientist will work closely with the Clinical Trial Lead/Medical Lead and Clinical Trial Manager to design and implement clinical trial protocols and manage sites, CROs and other associated work. In addition, the CS will support their manager to ensure program consistency & alignment across studies, working closely with cross-functional teams for achieving project goals, within timelines & with high quality. This clinical scientist will support early phase drug development in autoimmune indications.

Key Responsibilities

• Responsible to ensure the data review and cleaning activities meet the quality standards to support database locks in collaboration with data management and medical lead/clinical trial lead. Uses clinical and disease state knowledge to make recommendations for methods and strategy for data cleaning approach
• Collaborate with other functions to successfully support the planning and execution of clinical studies. Provides independent leadership of all areas requiring clinical input with oversight from the assigned Clinical Trial Lead/Medical Lead, and provides innovative and quality solutions for assigned problems and tasks.
• Provides clinical input and strategic recommendations for the planning and implementation of assigned clinical trial(s) including investigator selection, patient recruitment, feasibility questionnaire, training PowerPoints, and supporting Ethics committee submissions.
• Contributes to the strategic planning, preparation, and review of clinical documents (Protocol, ICFs, CSR, investigator brochure). May lead certain documents or sections of documents, including incorporation of input from other cross-functional team members.
• Provides clinical input and strategic recommendations for regulatory documents needed for all stages of assigned trial lifecycle (IND documentation, HA briefing books, BLAs, and Orphan Drug Applications).
• Responsible for clinical portions of key data management/statistical documents (eg: Case Report Forms, edit checks, data review plan and reports).
• Contribute to the planning and execution of external meetings and internal stakeholder meetings (e.g., Ad Boards, IMs, Governance, DMCs, Regulatory Authority, Dose Escalation meeting); responds to or triages questions for appropriate escalations. May have a speaking role on meetings when appropriate.
• Supports their manager when asked to contribute to harmonization between clinical trials and process improvement initiatives.
• May have the authority to make decisions related to issuing data cleaning queries and can decide whether there is a need to escalate for further discussion with the medical lead. They may also be delegated tasks from the clinical trial lead/medical lead for which they have decision making authority e.g. comment resolution when leading document creation.

Requirements

• At least a Bachelor’s degree in life science discipline.
• Bachelor’s degree with 4+ years’; or MS with 3+ years’; or PharmD/PhD with 2+ years of pharma experience in clinical development or related function.
• CAR-T cell therapy and/or autoimmune disease experience is a plus.
• Good interpersonal & communication skills, including oral, written and interpersonal.
• Ability to effectively manage conflicts and negotiations while providing impact and influence.
• Collaborative with the ability to operate across multiple geographies.
• Good leadership & organizational skills, analytical skills, and presentation skills.
• Creative problem-solving skills.
• Strong organizational and project management skill and the ability to multitask.
• Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project).
• Oncology Therapeutic Experience preferred.
• Excellent working knowledge of GCP, FDA and ICH Guidelines.

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Legend Biotech is seeking a Sr. Medical Science Liaison as part of the Medical Affairs team based Remotely in the Mid Atlantic Territory.

Role Overview

The Senior Medical Science Liaison (MSL) is a field‑based scientific expert within U.S. Medical Affairs, responsible for fostering credible, compliant, and non‑promotional scientific exchange with healthcare professionals (HCPs), investigators, and other external stakeholders in hematology/oncology.

This role serves as a key scientific partner across academic and community settings, supporting Legend Biotech’s marketed and pipeline assets through evidence‑based dialogue, clinical trial support, medical education, and generation of actionable medical insights. The Senior MSL operates with a high degree of autonomy, contributes to territory and national medical strategy execution, and may mentor or support the development of junior MSL colleagues.

Key Responsibilities

Scientific Engagement & External Partnerships

• Develop and maintain long‑term, peer‑to‑peer scientific relationships with key opinion leaders (KOLs), investigators, and other relevant healthcare stakeholders within the assigned territory.
• Deliver fair‑balanced, scientifically rigorous medical information in response to unsolicited requests, consistent with PhRMA Code, FDA regulations, and company SOPs.
• Serve as a trusted scientific resource on disease state, mechanism of action, clinical data, and emerging evidence related to Legend Biotech and relevant competitive landscapes.

Clinical Research & Development Support

• Act as the primary field‑based medical contact for investigators and research staff involved in company‑sponsored and investigator‑initiated studies.
• Support clinical trial feasibility, site identification, site initiation, and enrollment discussions in collaboration with Clinical Development and Clinical Operations.
• Provide education and support related to protocol concepts, safety reporting, and adverse event (AE) management, as appropriate and compliant.

Medical Strategy Execution & Insights

• Execute Medical Affairs strategies and tactics at the territory level in alignment with national medical plans.
• Collect, synthesize, and communicate high‑quality medical insights related to clinical practice, unmet needs, treatment paradigms, and competitive intelligence.
• Translate field insights into actionable recommendations for internal stakeholders to inform medical, clinical, and research strategies.

Scientific Exchange & Medical Education

• Support and participate in scientific congresses, symposia, advisory boards, and investigator meetings.
• Interpret scientific data presented at meetings and communicate key findings, trends, and implications to cross‑functional partners.
• Contribute to the development and continuous improvement of medical resources, training materials, and scientific content.

Cross‑Functional Collaboration & Leadership

• Collaborate effectively with internal partners including Medical Affairs, Clinical Development, Commercial (as appropriate), Regulatory, and strategic alliance teams while maintaining appropriate medical independence.
• Collaborate with alliance partners on field-based strategies and tactics
• Mentor and provide informal leadership support to newly hired or less experienced MSLs, as needed.
• Demonstrate strong judgment, adaptability, and professionalism in complex and evolving environments.

Compliance & Operational Excellence

• Adhere to all company policies, SOPs, and external regulations, including PhRMA Code, FDA guidance, and internal compliance standards.
• Maintain accurate and timely documentation of field activities, insights, and metrics using approved systems and tools.
• Manage territory operations effectively, including planning, prioritization, and travel logistics.

Requirements

• Advanced terminal degree (PharmD, PhD, MD, DO) or other advanced clinical degree (e.g., NP, PA) with relevant clinical experience.
• Minimum of 3-5 years of Medical Science Liaison experience in a therapeutic area aligned with hematology/oncology, immunology or CAR-T therapy; or 3-5 years of hematology/oncology clinical experience.
• Strong foundational knowledge of clinical research, trial design, and drug development processes.
• Demonstrated ability to engage in high‑level scientific exchange with expert clinicians and researchers.
• Excellent verbal, written, and presentation skills, with the ability to communicate complex scientific concepts clearly.
• Proven ability to work independently while collaborating effectively in a matrix organization.
• Valid U.S. driver’s license and ability to travel extensively, including overnight and occasional weekend travel.
• Residence within the assigned territory or within reasonable commuting distance.
• Core Competencies:
  • Scientific and Clinical Acumen
  • Strategic Thinking and Problem Solving
  • Insight Generation and Communication
  • Stakeholder Relationship Management
  • Emotional Intelligence and Professional Presence
  • Adaptability and Change Management
  • Compliance Mindset and Ethical Judgment
  • Digital and Technical Proficiency

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Legend Biotech is seeking an Associate Director, Operations Program Lead as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Operations Program Lead (OPL), Clinical Operations is accountable for accelerated operational delivery of 1-2 priority cell therapy development programs across all phases. This position is responsible for leading, managing and providing operational oversight for quality delivery within budget across all Legend Pipeline studies for 1-2 assets.

This individual must be able to work and lead in a small, fast-paced environment while also wearing multiple hats at any given time as the needs of the organization change and evolve. This position requires a high-performing contributor with strong leadership and stakeholder management skills. This individual will collaborate with the cross functional team to develop operationally feasible program timelines and identify clinical trial operational risks and develop mitigation strategies to ensure accelerated and cost-efficient quality clinical trial execution.  In addition, the position will ensure program consistency across studies, drive research and operational excellence through process improvement, and represent the clinical trial operation function at internal and external meetings.

This position will oversee 1-2 contractor Clinical Trial Associates (CTA).

Key Responsibilities

Direct end-to-end clinical trial management: 

• Direct end-to-end clinical trial operations activities domestically and globally: i.e. lead and take ownership in all aspects of Study Operations for CAR-T Studies in a matrix environment.
• Responsible for the overall success of the clinical study programs
• Ensures the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs. Ensures audit-ready condition of clinical trial documentation including central clinical files.
• Report on all aspects of the study progress at a granular level to stakeholders and senior leaders. Effective, consistent & regular tracking of project (s). Prepare and present project reports as required. Plans, executes, and leads study-specific meetings as needed (e.g., Senior and Mid-level management Study Management Meetings).
• Supports the Development of strategic plans for clinical trial operations, ensuring alignment with the company's overall goals and objectives.
• Collaborate with the cross-functional "core" teams to integrate clinical operations strategies into broader development plans.
• Define project timelines & deliverables, by working closely with the cross-functional core program team for end-to-end execution of clinical trials.
• Collaborates in the preparation and/or review of study-related documents (e.g., study protocols, informed consents and amendments, Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets and other study-specific documents or manuals).

Clinical Trial Operations Efficiency and optimization:

• The OPL will drive clinical Operations excellence by playing a critical role in Clinical Trial Operations Efficiency and optimization.
• Work with cross-functional teams and external vendors to identify clinical trial operational risks and develop mitigation strategies to ensure quality delivery of the clinical trial to support optimal and efficient clinical trial execution. 
• The position involves working closely with the clinical development team and collaboration with cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, tech ops, manufacture, supply chain, regulatory, project management, medical affairs, finance, legal and quality.
• Create and Manage study trial execution RACI to support overall trial execution and operational excellence.
• Contribute to Clinical Operations functional initiatives and institution of best practices.

Resource Management and Direct High Performing team:

• Manage and build a high-performing clinical operations support structure. Duties include hiring, onboarding, training, and development of staff to manage studies.
• Lead, develop and manage study operation manual, new work-streams, SOPs, study template, tracking tools, dashboards to support optimal clinical operation performance.
• Provides study-specific training and leadership to clinical research staff, including CRO, sites and other study personnel to support clinical trial execution and optimization.

Direct and Support Vendor Partnership

• Oversee vendor selection process, management, of Contract Research Organizations (CROs) and vendors involved in clinical trial Operation (CRO, Central Lab, etc).
• Participates in CRO and vendor study related calls and meetings, holds team members accountable for actions, escalates issues and oversees all aspects of daily study operations. Ability to identify issues and risks. Develops and manages mitigations and/or escalate risks appropriately.
• Negotiates vendor contracts / budgets and presents to the executive study team for approval.
• Review and confirm CRO and site payment invoices.
• Lead vendor performance assessment for continuous process improvement
• Management/oversight of external vendor deliverables reports and budgets.
• Collaborate within Clinical Operations and with study leadership team to create preferred vendor list for clinical development.

Leadership Skills

• Has critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream, and lateral implications of decisions that affect study outcomes and timelines.
• Adaptable / flexible, self-starter (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
• Excellent team player: willingness and ability to fill functional gaps in a small organization.
• Comfortable multi-tasking in a fast-paced small company startup environment and able to adjust workload based upon changing priorities.

Key Relationships

• The Operations Program Lead in Clinical Operations works closely with the asset Core Team and cross-functional teams such as safety, study monitoring, data management, biostatistics, bioanalytics, manufacturing, supply chain, regulatory, project management, medical affairs, and quality.
• Mentoring and management of a CTA.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• Oncology and/or Immunology clinical trial operations therapeutic experience required. 10+ years of pharmaceutical, biotech or CRO related/ oncology clinical research experience.
• Experience leading the operational planning and oversight of clinical trials as the point of accountability for operational delivery. (CAR-T trials experience is a plus).
• Demonstrated ability to deliver ambitious trial acceleration timelines within a competitive clinical trial landscape.
• Phase 1 clinical trial operational experience is preferred.
• Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and FDA/ICH regulatory requirements are essential.
• This position requires experience and leading study/project management to create study project plans, and end-to end-study timelines for execution of clinical trials.
• Demonstrated ability to multi-task and manage high performance demands.
• Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• CRO/Vendor oversight experience required.
• Project Management (biotech) experience a plus.
• Regulatory authority inspection experience a plus.
• Ability to travel as necessary (approximately 10 – 15 %); both domestically and internationally.
• Effective oral, written and interpersonal communication skills.
• Strong communication and presentation skills.
• Forward and critical thinker.
• SOP development experience preferred.
• Strong organizational and project management skills, and the ability to multitask.
• Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project).
• Excellent working knowledge GCP, FDA and ICH Guidelines.

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Legend Biotech is seeking a Senior Clinical Trial Associate (Contractor) as part of the Clinical Operations team based remotely. 

Role Overview

We are seeking a highly skilled and motivated Senior Clinical Trial Associate (Sr. CTA) to join our growing Clinical Operations team to support early-stage clinical development. The Sr. CTA will play a critical role in the execution of complex Phase I/II CAR-T oncology clinical trials by providing high-quality operational, administrative, and coordination support.

The ideal candidate will have substantial experience in clinical trial operations and administration, with a strong understanding of clinical trial processes, regulatory requirements, and GCP. This role is critical to ensuring the efficient execution of clinical trials, maintaining regulatory compliance, and providing operational support to cross functional study teams.

Contract Duration: 12 months

Key Responsibilities

Clinical Trial Operations Support
• Provide cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study-related forums.
• Support Senior Clinical Trial Managers in the day-to-day execution of complex Phase I and Phase II CAR-T oncology trials, ensuring all activities are conducted in compliance
with ICH-GCP and applicable regulatory requirements.
Documentation & TMF Management
• Oversee the preparation, organization, and maintenance of trial documentation, including regulatory files, Trial Master Files (TMFs/eTMFs), and study correspondence.
• Ensure documentation is current, complete, and compliant with ICH-GCP and company SOPs.
End-to-End Trial Coordination
• Assist with the planning, start-up, execution, and close-out of clinical trials, including coordination with clinical sites and support of protocol and regulatory compliance activities.
Regulatory & Compliance Support
• Assist with the preparation, submission, and tracking of regulatory and IRB/IEC documents.
• Maintain working knowledge of applicable regulations and standards to support ongoing study compliance.
Meeting & Communication Coordination
• Schedule and coordinate study meetings, including investigator meetings, site visits, and internal team meetings.
• Prepare meeting agendas, document minutes, track action items, and follow up to ensure timely completion.
Tracking, Reporting & Data Support
• Assist in tracking trial progress, including site activation, enrollment, monitoring activities, and key study milestones.
• Prepare and maintain study status reports and trackers for internal and external stakeholders.
• Support data management activities, including query tracking and data reconciliation, in collaboration with Data Management.
Site & Vendor Support
• Serve as a key liaison between the clinical trial team, vendors, CROs, and investigational sites to ensure clear and timely communication.
• Assist with vendor oversight by tracking deliverables, timelines, and resolving operational issues.
Problem Solving & Continuous Improvement
• Proactively identify operational issues and risks, propose solutions, and escalate to the Senior Clinical Trial Manager or Clinical Operations leadership as appropriate.
• Contribute to the development and continuous improvement of clinical operations processes and best practices.
Training & Mentorship
• Provide guidance and mentorship to junior CTAs, sharing best practices and contributing to team capability building.

Requirements

Education
• Bachelor’s degree in life sciences, clinical research, or a related field.
• Relevant certifications (e.g., CRC, CRA) are a plus.

Experience
• Minimum of 3–5 years of experience as a Clinical Trial Associate or in a similar clinical research role.
• Demonstrated experience supporting trial coordination, regulatory documentation, and site management activities.
• Oncology and/or Autoimmune Disease trial experience required; cell therapy and/or CAR-T experience strongly preferred.
Skills & Competencies
• Strong understanding of ICH-GCP, regulatory requirements, and clinical trial processes.
• Proficiency with CTMS, eTMF, and EDC systems.
• Excellent organizational skills with the ability to manage multiple priorities in a fastpaced environment.
• Strong written and verbal communication skills.
• Detail-oriented with strong analytical and problem-solving skills.
• Ability to work independently and collaboratively within cross-functional teams.
Technical Skills
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with eTMF and EDC platforms.

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Legend Biotech is seeking a Sr. Director, Clinical Operations Capabilities and Standards as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Sr. Director, Clinical Operations Capabilities and Standards will be responsible for providing strategic leadership and oversight for foundational and centralized trial operations support towards cost-effective scalability of the Clinical Operations department. 

Among other responsibilities, this position will establish, oversee and grow Clinical Operations capability pillars that include Clinical Trial Planning and Analytics, Clinical Trial Operational Technologies, Vendor Alliance Management, Site Contracts & Payments, and Sample & Imaging Management Operations; including managing and developing staff within each pillar.

This position will also be the company subject-matter expert for clinical operations standards applied across the portfolio of Legend IND clinical trials.

Key Responsibilities

Oversee the development and strengthening of the following clinical operations capabilities and functions, with leads/teams in each of these areas:

Clinical Trial Planning & Analytics:

• Clinical Trial Planning and Analytics (CTP&A) is accountable for end‑to‑end clinical trial feasibility activities, supporting protocol optimization, country and site selection, enrollment forecasting, and risk mitigation across clinical programs.
• This function provides data‑driven feasibility insights to enable informed decision‑making during early study planning and partners closely with Clinical Operations Leads, Clinical Development, cross-functional stakeholders and external vendors to ensure trials are designed and placed for successful execution.
• This function is responsible for predictive trial performance modeling to enable proactive implementation of contingency plans

Clinical Trial Operational Technologies:

• The Clinical Trial Operations Technology function is responsible for the strategic ownership, governance, and optimization of clinical trial operations systems that enable compliant, efficient, and inspection‑ready execution of clinical trials.
• This function serves as the business owner for core clinical systems (e.g., CTMS, eTMF, and related platforms), ensuring alignment with clinical operations needs, regulatory requirements, and the company’s development portfolio. The position partners closely with Clinical Operations Leads, Quality, Regulatory, Data Management, IT, and CROs/external vendors.
• Areas of focus for capability building include leveraging technology to enable cost-efficient trial budget builds and ongoing costs optimization during study execution, enabling tools for targeted clinical operations risk management and technology-enabled eTMF oversight.

Vendor Alliance Management:

• Vendor Alliance Management is responsible for the strategic and operational oversight of external clinical operations vendors and CRO partners supporting clinical trials, including coordination of vendor due diligence for vendor qualification. Ensures vendors deliver high‑quality services in compliance with GxP and contractual expectations, while enabling efficient study execution across one or more clinical programs.
• Vendor Alliance Management is the primary interface between internal Clinical Operations Program Leads and external service providers, with accountability for vendor governance, performance management via objective metrics, issue escalation, and continuous improvement.

Site contracts and Payments

• Site Contracts & Payments is responsible for creating and overseeing a scalable and effective operating model for site contracting visibility, investigator payment operations, serving as a central point of accountability for improving operational control, process effectiveness, financial discipline, vendor performance consistency, and sponsor-CRO-site workflow alignment.

Sample and Imaging Management Operations

• Sample and Imaging Management is responsible for end-to-end sample and imaging oversight across Legend pipeline studies. To strengthen visibility, accountability, and coordination across sites, CROs, central labs, specialty labs, imaging vendors.
• Sample and Imaging Management focuses on system‑level consistency and risk reduction, mitigating against loss of patient data, enabling acceleration of data cleaning and reducing site burden for participation in clinical trials.
• Lead business owner for clinical operations standards and practices, including functional owner for clinical operational related SOPs and guidance documents.
• Performs other duties as required.

Key Relationships

• The Head of Clinical Operations Capabilities and Standards works closely with all applicable internal cross-functional leaders and teams as well as external vendors for the clinical operations capability building and strengthening.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• 12+ years of progressive experience in pharmaceutical or biotechnology clinical operations, with demonstrated leadership responsibility across global clinical development programs.
• Significant experience in establishing, scaling, or transforming centralized Clinical Operations capabilities, including one or more of the following:
  • Clinical Trial Planning & Analytics / Feasibility
  • Clinical Trial Operational Technologies (e.g., CTMS, eTMF, analytics platforms)
  • Vendor Alliance Management
  • Site Contracts and Investigator Payments
  • Sample and Imaging Management Operations
• Proven expertise in end‑to‑end clinical trial conduct, including early‑phase through late‑phase trials, with strong understanding of protocol development, feasibility, start‑up, execution, and close‑out.
• Demonstrated strategic CRO and vendor oversight experience, including governance models, performance metrics, financial oversight, issue escalation, and continuous improvement.
• Experience acting as a functional or enterprise‑level clinical operations subject‑matter expert, defining standards, operating models, and best practices applied across multiple studies or programs.
• Strong background collaborating with Quality, Regulatory, Clinical Development, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Translational/Bioanalytical, Medical Affairs, Procurement, Legal and IT functions in a matrixed global environment.
• Experience participating in and/or supporting regulatory authority interactions (e.g., FDA inspections) related to clinical operations processes, vendors, systems, or trial conduct is strongly preferred.
• Demonstrated success leading, developing, and retaining high‑performing teams, including functional leaders.
• Willingness to travel as required (approximately 10%).
• Deep knowledge of clinical trial operations frameworks, including industry best practices and regulatory expectations (ICH‑GCP, FDA, and global health authorities).
• Strong capability in clinical operations operating model design, including centralization, standardization, governance, and scalability.
• Demonstrated leadership in clinical operations technology enablement, including business ownership of systems (e.g., CTMS, eTMF), data quality oversight, technology‑enabled risk management, and inspection readiness.
• Expertise in vendor and alliance management, including development of governance structures, KPI frameworks, financial oversight, and performance optimization.
• Understanding of clinical trial sample, imaging, and data flows, with ability to design operational controls that reduce patient data risk, site burden, and cycle times.
• Ability to translate portfolio‑level strategy into executable clinical operations capabilities, standards, and guidance.
• Proven strategic and critical thinking skills, with a data‑driven mindset and ability to anticipate operational risks and mitigation strategies.
• Strong experience developing, authoring, and governing clinical operations SOPs, standards, and guidance documents.
• Exceptional communication, presentation, and stakeholder influence skills, with the ability to engage senior leadership and cross‑functional teams.
• High proficiency with clinical operations–relevant technologies and tools, including MS Office (Excel, PowerPoint, Word) and enterprise clinical systems; ability to leverage analytics for operational decision‑making.

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#Li-Hybrid

Role Overview

We are seeking a Sr. Technical Product Manager to lead the strategy and execution of data product, AI/ML system, AI-powered tooling, and automation initiatives across Patient Experience and Commercial Operations functions. This role is focused on improving how patients navigate testing and billing while enabling operational teams to efficiently progress cases from order to completion. You will play a crucial part in supporting initiatives to reduce friction, improve patient trust, and increase operational efficiency, ultimately driving better conversion, collections, and experience.

This role focuses on building, scaling, and leveraging platforms and products that power decision intelligence and activity orchestration across these domains. You will work in close collaboration with domain leaders while building through centralized Data & AI organization platforms, standards, and governance. You will own the full product lifecycle from discovery through production, ensuring solutions are adopted, trusted, and deliver measurable business impact. In doing so, you will work hands-on as an empowered builder of AI and software solutions to improve workflow efficiency, productivity, and quality for the teams you support.

This is a technical product role requiring fluency in data systems, modern data platforms, ML, and AI implementation patterns (and the ability and drive to build with them directly), combined with strong experience and stakeholder intuition across the associated functions. The role has direct ownership of high-impact initiatives that deeply influence organizational success.

What You’ll Do

Strategy & Roadmap

• Define and own the Data & AI product strategy and roadmap for the Patient Experience + Commercial Operations pod by deeply partnering with business leaders to proactively identify high-impact opportunities, shape problem definitions, and drive aligned priorities
• Translate ambiguous business problems (e.g., stuck cases, fragmented patient communication, support inefficiencies, billing friction) into clear product direction and measurable outcomes
• Own the line between 'what the business needs' and 'what gets built' end-to-end

Discovery, Experimentation, & Requirements

• Develop deep context on the domain so you can proactively propose solutions rather than field requests
• Be hands-on with data: query datasets, review schemas, and validate assumptions through analysis
• Lead end-to-end product discovery with interviews, workflow mapping, data assessments, ROI modeling, etc.
• Define clear product requirements (PRDs, user stories, acceptance criteria) and success metrics
• Design and run experiments to validate product performance and measure causal impact
• Establish leading indicators and KPIs for proactive product and process health assessments

Delivery, Data, & ML Lifecycle

• Partner with data and AI/ML engineering resources to deliver scalable products and capabilities
• Guide development of robust data pipelines and unified data models (360° views across key entities)
• Own the end-to-end ML lifecycle: feature definition, evaluation, deployment, monitoring, drift detection, and retraining
• Ensure training–serving consistency, model versioning, and clear deployment decision gates
• Establish strong observability across data pipelines and models (data quality, latency, reliability, cost)

AI Productization & Hands-On Building

• Define and implement AI product patterns, including agentic workflows and tool/function-calling integrations
• Build process automations and internal tools that improve workflow efficiency, productivity, and output quality for the teams you support
• Establish evaluation frameworks for LLM-powered features (faithfulness, relevance, safety, cost, latency)
• Implement prompt strategies, guardrails, and continuous evaluation pipelines

Governance, Compliance, & Data Quality

• Ensure products meet regulatory and compliance requirements
• Champion data quality, lineage, and reliability through data contracts and observability standards
• Maintain strong documentation practices (e.g., model cards, dataset documentation, audit trails)
• Partner with governance teams (Security, Legal, Compliance, AI Governance) to operationalize AI responsibly

Adoption, Change Management, & Impact

• Launch products with supporting enablement activities to ensure solutions are embedded in workflows with confidence
• Partner with stakeholders to integrate products into proactive, day-to-day decision-making
• Monitor product usage, performance, and business outcomes to iterate based on data and feedback
• Quantify and communicate impact (e.g., revenue lift, cost reduction, cycle time improvements, case completion turnaround)
• Influence Patient Experience and Commercial Operations stakeholders through delivery, not authority

Qualifications

Required

• 7+ years of relevant experience (e.g., product management, applied AI/ML engineering, technical founder, forward-deployed engineering), including 3+ years building data products, AI/ML systems, or related platforms
• Demonstrated domain fluency in Patient Experience and/or Commercial Operations
• Strong understanding of patient journeys, support channels (e.g., chat, voice, call centers), and operational workflows that drive conversion and test completion
• Familiarity with key domain-relevant tooling (e.g., patient portals, support platforms) and associated data
• Strong technical capability (e.g., comfortable scripting, performing EDA, with AI-aided application development)
• Hands-on experience shipping LLM-powered features or automations (e.g., prompting, RAG, tool/function calling, agentic orchestration, evals)
• ML/MLOps literacy (evaluation metrics, experimentation, feature stores, CI/CD, monitoring, drift)
• Familiarity with modern data stacks (e.g., Snowflake, dbt, AWS/SageMaker, Airflow/Dagster)
• Strong stakeholder leadership and communication skills, with the ability to work across technical and business teams
• Experience working in regulated environments (e.g., healthcare, life sciences, fintech)

Preferred

• Experience in healthcare, diagnostics, life sciences, and/or digital health
• Familiarity with healthcare data domains and systems, including patient, provider, payer, claims, billing, and clinical trial data
• Experience with vendor evaluation, platform selection, or external AI tooling ecosystems
• Advanced degree in a technical and/or business discipline

What Success Looks Like

• Production-grade data and AI products are deployed and embedded in day-to-day decision-making workflows
• Process automations and internal tools you build are reducing manual effort and improving output quality across the teams you support
• Measurable improvements seen in key business metrics (e.g., case completion turnaround time, patient satisfaction, cost-to-serve)
• Reliable, high-quality data foundations connect patient, provider, clinical, operational, and billing/financial insights end-to-end
• AI systems are continuously monitored, evaluated, and improved with measurable business impact
• Stakeholders trust and adopt implemented solutions across both corporate and business-unit teams
• Internal teams have transparent access to the function's roadmap, trust in delivery against it, and visibility into the evaluation logic that prioritizes initiatives based on their impact to organizational goals

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases.

Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

About the Role

The Director of Clinical Operations will serve as the cross-functional study team lead for a high-priority hematology program, with overall accountability for the strategic planning and execution of all operational activities. This role will provide leadership and oversight of CROs and vendors, including governance, to ensure delivery against timelines, quality, and budget expectations.

The individual will work collaboratively with internal functional leads (Clinical Development, Regulatory, Translational, Data Management, and Biostatistics) to drive integrated study execution, while providing strategic direction and ensuring alignment across stakeholders. They will demonstrate strong matrix leadership, proactive risk identification and mitigation, and effective problem-solving to achieve key program milestones.

This role requires the ability to balance budget, timelines, and evolving trial needs, maintaining transparency and a solution-oriented approach to decision-making. A strong focus on data quality, inspection readiness, and overall trial execution excellence is essential.

This candidate can be remotely based, and ideally attends relevant congresses, conducts on-site visits and joins the greater team at Caribou headquarters (Berkeley, CA) as able.

Responsibilities:

• Provide strategic operational leadership and oversight for a key clinical program, ensuring alignment with clinical development objectives and corporate goals
• Oversee CROs and vendors, leading governance and partnering closely to ensure accountability for delivery of operational activities, timelines, quality, and budget, and driving proactive risk management and mitigation across the study
• Lead study-specific and cross-functional meetings, driving clear decisions, accountability, and timely issue resolution
• Collaborate cross-functionally (Clinical, Regulatory, Translational, Data Management, Biostatistics) to ensure integrated and efficient study execution
• Oversee study progress and performance using key metrics (e.g., enrollment, eligibility, data quality, primary endpoints), ensuring transparent communication and a solution-oriented approach
• Proactively identify, assess, and manage study and program-level risks, including mitigation planning and escalation of critical issues
• Ensure data quality, integrity, and completeness to support analyses, regulatory submissions, and program decision-making
• Establish and oversee vendor governance, including performance management, SOW/budget review, and financial tracking (forecasts, accruals)
• Ensure inspection readiness, including TMF quality, audit preparedness, and compliance with GCP and internal SOPs
• Build and maintain strong relationships with investigators, study staff, and external partners, and represent Clinical Operations in internal governance and external interactions

Requirements:

• Bachelor’s Degree is required, in a science or a health-related field
• A minimum of 10 years of global clinical trial management experience within the pharmaceutical or biotechnology industry
• Early phase oncology focus is key, preferably within the hematology space
• In-depth understanding and experience across clinical operations with a track record of success in CRO and vendor delivery oversight
• Being a key contributor to study planning, execution, data cleaning, database locking, study report generation and regulatory inspection
• Experience with developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred
• Ability to lead cross functional study teams in a dynamic, evolving organization
• Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions (internally and externally)
• Ability to travel up to 20% based on business needs

Nice-to-Haves:

• Prior experience in the CAR-T space, with a specific focus in hematology
• An emphasis on inspection readiness for Clinical Operations
• Ease and confidence in being Investigator and site-facing

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $240,000-$255,000; this represents the present low and high end of the Company’s pay range for this position; actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance
• Generous paid vacation time, in addition to company-observed holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program

The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.

Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc. for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee.

Seeking talent near: Princeton, NJ

Position Summary:

In support of clinical development programs, the Director of Clinical Trial Materials role oversees Clinical Trial Material (CTM) planning and execution activities, supporting Phase 1-IV and IIS trials. Includes demand forecasting, determination of an appropriate presentation, setting production schedules, protocol review, ensures label compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies and monitors product re-test dates. Interface with internal departments and contract research organizations (CROs) as necessary to coordinate the execution of these activities.  Implements and ensures group compliance to procedures for the production and distribution of investigation product. Manage junior colleagues in the CTM team as required. 

Primary Responsibilities:

• Review and Interpretation of a clinical protocol or study overview:
  • Review and provide feedback during the development of the clinical protocol.
  • Calculate total demand and translation of total demand into a demand forecast.
  • Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.
  • Periodically reviews and updates inventories including all supply related information such as lot numbers, current status, and kit genealogy and expiration date extension.
  • Contributes to CTM procedures in line with current regulatory requirements
  • Tracks expired materials and issues orders for retrieval or disposal.
  • Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.
  • Proposes and implements improvements to ensure efficient clinical supply operations.
  • Investigates and resolves issues regarding inventory, shipments and returns.
  • Responsible for end to end, full CTM lifecycle ensures that all clinical trials have timely and an un-interrupted supply of CTM.
• Direct CTM activities with Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D staff, Project Teams, IT/IS, Data Management, CROs and other sites and departments as necessary
• Develops and maintains CTM documentation necessary to support company policies, procedures and all regulatory guidelines
• Works with Clinical, Regulatory and Quality teams in preparing label text, obtaining translations and approval of label proofs
• Prepares and reviews applicable contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness
• Reconciles and approves invoices
• Prepares reports to ensure accuracy and completeness of clinical supplies information.  Maintains departmental reports and files, updates SOPs and other projects assigned

Education/Experience/Skills

• Minimum Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree). Equivalent combination of relevant education and applicable job experience may be considered with at least 10+ years’ experience in pharmaceutical development focused on clinical trial materials
• The individual must be well versed in GXPs (GMP, GCP, and GDP) and as well as other regulatory requirements as they pertain to investigational products
• Demonstrated leadership skills
• Proven project management skills
• Ability to handle multiple projects simultaneously
• Good understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH, 21 CFR Part 11)
• Good understanding of IRT system build-up and user testing
• Good negotiating skills with customers and suppliers
• Hands on training and experience in clinical trial methodology and Good Clinical Practice
• Good organizational and documentation skills
• Demonstrated track record of ability to self-direct and resolve issues with the vendors, CRO staff and internal teams
• Excellent written and verbal communication skills
• Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization
• Skilled at creating a cooperative team environment
• Able to objectively evaluate situations and make recommendations for changes in light of overall project demands

Physical Requirements:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #NC1

Who we are:

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn. 

How we work:

• PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
• COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
• BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

How you’ll make an impact:

• Contribute to the planning, implementation, and execution of global clinical trials.
• Plan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings, etc), as needed.
• Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.
• Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel.
• Manage study timelines and metrics to ensure completion of study deliverables.
• Lead site feasibility and selection qualification, initiation, and oversight of outsourced monitoring activities.
• Review monitoring reports to ensure quality and resolution of site-related issues.
• Ensure timely enrollment and data collection at clinical trial sites.
• Collaborate with the data management team to ensure data integrity and timely database lock.
• Ensure tracking, review of protocol deviations, and assess impact on study data.
• Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.
• Partner with Operational Excellence and assigned Site Engagement Leads to help drive site engagement and bolster recruitment
• Serve as key counterpart of Clinical Outsourcing to build RFPs and support the selection of clinical vendors
• Oversee and contribute to Sponsor Oversight activities including but not limited to review of KPIs, KRIs, PDs, risks, Data Review Findings, etc. to assess the health of the study and proactively ensure mitigations are in place to achieve Kymera’s quality standards
• Contribute to clinical operations process improvement initiatives
• Maintain accurate and complete trial documentation.
• Proactively identify and resolve clinical project issues.
• This role may require up to 25% travel

Skills and experience you’ll bring:

• BS degree and 8+ years of experience in clinical operations in biotech/pharma. 5 years’ experience leading global clinical trials
• Inspection readiness experience preferred
• Experience working on large, global, complex phase 2b/3 or late stage trials. Respiratory or Immunology experience highly preferred.
• Broad knowledge of Global regulations and guidelines including CFR, ICH GCP, HIPAA, GDPR, and the Protection of Human Research Subjects.
• Strong project management skills with the ability to manage multiple trials simultaneously.
• Excellent problem-solving, leadership, and communication skills.
• Ability to work in a fast-paced, dynamic environment with cross-functional teams. 

Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.

Compensation

• Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
• The anticipated base salary range for this role is $160,000 – $275,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
• Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate’s depth of experience and the capabilities they bring to the position.

The Impact You’ll Make

Recursion is at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking a highly motivated, skilled, and adaptable Senior Clinical Project Manager within our Clinical Operations team who will lead the conduct and execution of one or more clinical trials from study start-up to study closure with support or direction from an Associate Director/Director of Clinical Operations. 

In this role, you will:

• Lead all aspects of clinical trial execution for one or more programs from IND through proof-of-concept and pivotal studies
• Plan and oversee implementation, coordination, and execution of global clinical trials including, but not limited to, oversight of study budgets, financial reporting, and forecasting in collaboration with Clinical Outsourcing
• Develop and maintain strong relationships with cross-functional study teams, CROs, clinical investigators, and clinical trial stakeholders
• Manage clinical trial operations and lead study teams, including CROs and vendors, and reporting of start-up, conduct, and close-out activities
• Ensure compliance with study protocol and applicable Standard Operating Procedures (SOP), Good Clinical Practices (GCP), ICH and local regulations

The Team You’ll Join 

Reporting to an Associate Director/Director of Clinical Operations, you will be an essential member of the Clinical Operations team within Development. This team is dedicated to ensuring operational excellence across our clinical programs.The Development Team is an empowered, execution-minded group of drug development professionals responsible for translating Recursion’s innovative science to patients through clinical development activities. 

The Experience You’ll Need

• Bachelor’s degree in a scientific or healthcare-related field
• 8+ years of experience in a clinical operations role in the biopharmaceutical industry, with at least 3+ years experience in leading clinical trials and project management within a biotech organization required 
• Early phase (Phase 1, 2) oncology experience at a biotech/Sponsor is required 
• Demonstrated experience organizing and leading clinical study teams
• Preferred Skills: proficiency managing timelines, tasks, milestones working in SmartSheet or similar project management software
• Demonstrated track-record of efficient and effective clinical trial planning and execution, including risk management and mitigation strategies
• Experience in vendor and CRO selection,management, and oversight
• Experience managing and tracking study budgets and financials with participation and involvement with invoice and contract review and approvals
• Experience working closely with data management and clinical teams to set up study systems and ensure quality data collection through monitoring, cleaning and analysis 
• Preferred: CRF development and IRT build experience, knowledge of data listings used for monitoring and cleaning, contribution to data management related plans and specifications
• Excellent working knowledge of FDA, ICH, GCP regulations and guidelines

Working Location & Compensation:

This position is open to both remote and hybrid models. The hybrid position would be office-based at either our office located in New York City, New York or Salt Lake City, Utah. Employees are expected to work in the office at least 50% of the time. Relocation support can be provided for candidates not local to either geographical location. 

At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $165,900 to $211,100. You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package. 

#LI-DB1 

#LI-REMOTE

About Us

At Prenuvo, we are on a mission to flip the paradigm from reactive “sick-care” to proactive health care. Our award-winning whole body scan is fast (under 1 hour), safe (MRI has no ionizing radiation), and non-invasive (no contrast). Our unique integrated stack of optimized hardware, software, and increasingly AI, coupled with the patient-centric experience across our domestic and global clinics, have allowed us to lead the change against “we caught it too late again".

We are looking for a Senior Counsel - Litigation & Employment to join our legal team and contribute to our mission of making a meaningful impact on preventative health. You will manage the company’s full litigation portfolio and serve as the go-to legal partner for our People & Culture team. Reporting to the General Counsel, you will lead strategy across commercial disputes, medical malpractice claims, and employment matters while proactively reducing risk across a fast-scaling, multi–jurisdictional healthcare business. 

This is a role suited to someone who thrives in a fast paced environment, can shift between strategic counseling and hands-on execution, and communicates legal concepts in plain language to clinical and business leaders. 

Help reshape the world through proactive healthcare while working with cutting-edge technology and high performing teams with deep expertise - join us to make a difference in people’s lives!

What You'll Do

Litigation Management

• Own and manage Prenuvo's litigation and pre-litigation docket, including commercial disputes, medical malpractice claims, employment-related claims, and other general litigation matters.
• Direct outside counsel strategy across multiple jurisdictions; manage discovery, witness preparation, settlement evaluation, and trial readiness.
• Conduct and manage internal investigations related to legal and compliance issues related to pending and threatened litigation.
• Oversee litigation holds, document preservation, and e-discovery processes.
• Track and report on litigation matters, exposure, and budgets to the General Counsel.

Proactive Risk Management

• Partner with operations teams to identify liability risks in service delivery and implement process improvements that reduce exposure.
• Monitor legal and regulatory developments affecting Prenuvo's business across the US, Canada, UK, and Australia.
• Develop and deliver training for managers and clinical staff on litigation prevention and regulatory compliance topics.

Employment Law & People Advisory

• Serve as primary legal advisor to the People & Culture team on employee relations, including performance management, workplace investigations, disciplinary actions, accommodation requests, and separations.
• Draft, review, and update employment policies and handbooks to align with applicable laws across all jurisdictions where Prenuvo operates.
• Advise on employment-related risk in connection with workforce changes, reductions, and organizational restructuring.

General

• Manage relationships with outside counsel.
• Contribute to building the legal team's processes and infrastructure to support a high-growth healthcare company.
• Other responsibilities as needed.

What You’ll Bring

• J.D. from an ABA-accredited law school (or equivalent legal qualification from a jurisdiction where Prenuvo operates) and active bar membership in good standing in at least one US state.
• 7+ years of legal experience in litigation (healthcare liability experience required) and employment law, with a mix of law firm and in-house experience preferred.
• Demonstrated experience managing outside counsel, including strategy, budget, and performance.
• Experience advising on employee relations matters, conducting or overseeing workplace investigations, and drafting employment policies.
• Sound judgment in assessing risk and the ability to work independently while knowing when to escalate.
• Strong written and oral communication skills, with the ability to translate legal concepts into clear, actionable guidance for non-legal stakeholders
• Comfort operating in a fast-paced, high-growth environment with meaningful ambiguity.

Our Values 

First: we are Pioneers

• Transforming healthcare requires divergent thinking, bias for action, disciplined experimentation, and consistent grit and determination to maintain momentum. This journey is as challenging as it is rewarding.

Second: we are Platform-Builders

• We’re always building foundations that allow us to achieve tomorrow more than we did today. We never lose sight of what’s ahead – in a mindset of ownership and duty to our mission.

Above all: we are Patients

• We could all be the next person who walks through our very doors, seeking clarity or peace of mind. We are proud of our impact on our patients’ lives, and we won’t stop till everyone can benefit from our work.

What We Offer

• An avenue to make a positive impact on people's lives and their health
• We believe in preventative healthcare for everyone, including our team - Prenuvo provides free, whole-body scans to each team member 
• Growth opportunities are at the heart of our people journey, we’re doing big things with bright minds - there is no single path to success, it can be shaped along the way
• Building strong relationships is at the core of everything we do - our team gets together each week to connect, share, and socialize 
• Recognizing time away to restore is vital to our wellbeing - we have a flexible vacation policy and we will encourage you to use it
• We now offer the Prenuvo’s Commuter Benefits Plan to help cover your transit and parking costs. Whether you ride, drive, or park, we’ve got you covered—making your commute easier and more affordable! 
• Prenuvo offers a 401(k) retirement savings plan to eligible employees, allowing team members to make pre-tax contributions toward their retirement. While Prenuvo facilitates access to the plan, the company does not currently offer matching contributions.
• We offer a comprehensive benefits package including health, dental, vision, including Mental Health coverage, to support you and your family
• The base salary for this role ranges from $215,000-$235,000 in local currency, depending upon experience and geographic location

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

As part of the hiring process, successful candidates will undergo a background check in compliance to applicable federal, provincial, and state rules.

Please be advised that official communication from our recruitment team will only come from our authorized domain [prenuvo.com]. If you are contacted by a recruiter, please ensure their email address ends with @prenuvo.com. We do not use third-party recruitment services or any other email domains for hiring purposes. If you receive communication that you believe to be fraudulent, please report it immediately to jobs@prenuvo.com.

Your impact 

As a Senior Security Engineer, you will architect and manage the security of our groundbreaking ML-based platform and High Performance Computing (HPC) infrastructure. This role requires a highly proactive problem-solver who enjoys a fast-paced environment and possesses the curiosity to dive into diverse technical challenges. 

You will act as a versatile, T-shaped engineer, overseeing security solutions from initial requirement gathering to final implementation. By combining deep technical know-how with strong collaborative skills, you will ensure our security posture evolves as quickly as our research, managing the end-to-end lifecycle of our defense systems.

What you will do

• Secure Architecture and Product Engineering: Participate in the design and perform security reviews of our evolving AI platforms and underlying HPC infrastructure.
• Infrastructure as Code (IaC) Security: Partner with our DevOps / SRE team to harden our cloud infrastructure and our network, ensuring security by design, automation and auditability through Policy as Code.
• Third Party Systems Secure Integration: Perform deep-dive technical assessments of third-party platforms, AI solutions, Cloud or SaaS providers and support secure integration or deployment.
• Secure CI/CD: Design and implement automated security controls within our CI/CD pipelines to ensure code is secure from commit to production without slowing down research velocity.
• Threat Modeling & Risk Assessment: Conduct proactive threat modeling and risk assessment, support teams in the implementation of remediation plan and audit expected outcomes.
• Incident Response: Act as a L2/L3 escalation point for the remediation of complex vulnerabilities and security incidents.
• Identity & Access Management: Implement our state-of-the-art Zero Trust framework, ensuring robust access control and consistent enforcement of the principle of least privilege.
• Risk Management and Compliance Automation: Bridge the gap between technical controls and regulatory requirements (GDPR, GxP, EU AI Act) by automating evidence collection and risk posture monitoring (CSPM).
• Security Tooling Development: Build or integrate custom internal tools that automate repetitive security tasks, shifting our operational load from manual toil to scalable engineering.
• End-to-End Solution Delivery: Manage the full lifecycle of security controls, from initial user needs analysis and requirements gathering to structured testing and phased implementation and communication, ensuring high-quality deployment followed by data-driven continuous improvement.

Skills and qualifications 

Essential

• Cloud Engineering Proficiency: Deep technical knowledge of cloud platform security (GCP preferred) including Network and VPC design, IAM policy construction, Cloud resources hardening and Cloud native security services.
• Analytical Risk Management and Problem Solving: Proficiency in assessing multi-faceted risks and decomposing complex security issues into manageable tasks and providing data-driven recommendations to stakeholders.
• Coding Skills: Ability to write small production-grade code (e.g. in Python) and to automate security tasks, build custom tooling, etc.
• DevSecOps Tooling: Hands-on experience with Infrastructure as Code (Terraform) and version control systems (GitHub) to manage security configurations.
• Container Security: Proven ability to secure containerized workloads (Kubernetes/Docker), focusing on image signing, runtime protection, and orchestration security.
• Network Security Fundamentals: Solid understanding of modern networking, including zero-trust architecture, encryption in transit (TLS/mTLS), and API gateway security.
• Identities and Access Management: Proficiency in implementing a state of the art IAM strategy both from an organisational and technical standpoints in a multi-tenant cloud environment.
• Collaborative Security Culture: Strong ability to support researchers in AI and Drug Discovery, leveraging excellent listening skills, to provide pragmatic advice that balances high-security requirements with business agility.
• Adaptability & Communication: Excellent soft skills with the ability to navigate an ambiguous, high-growth environment and explain technical risks to non-security audiences.
• Offensive Mindset: Strong understanding of the MITRE ATT&CK framework and the ability to think like an adversary to identify "blind spots" in our defense.

Nice to have

• AI/ML Security Interest: Familiarity with the unique security challenges of an AI first company and other common AI solutions such as LLMs.
• Regulated Industry Experience: Prior experience working in BioTech, Pharma where data integrity and regulatory compliance are paramount.
• Advanced Security Certifications: Holding industry-recognized credentials such as GSE, OSCP, CISSP or professional-level Cloud Security Engineer certifications.
• Application Security (AppSec): Experience with SAST/DAST/SCA tools and a strong understanding of the OWASP Top 10 vulnerabilities.
• Zero Trust Implementation: Past success in transitioning an organization away from traditional perimeter-based security toward a mature Zero Trust model.
• SecOps Maturity: Experience building or scaling a Security Operations Center (SOC) or a Modern Detection and Response (MDR) function.
• Collaboration Tool Mastery: Advanced experience securing and automating SaaS. In particular, Google Workspace, the Atlassian stack (Jira/Confluence), Slack.
• Bio-Pharma Experience: Prior exposure to GxP validation, clinical trial data protections, or the nuances of Lab-IT security.
• Privacy Engineering: Knowledge of PETs (Privacy Enhancing Technologies) like differential privacy or homomorphic encryption.