Why Join Us?

As a member of the Parabilis Medicines team, you will be a part of an organization dedicated to creating extraordinary medicines for diseases with urgent unmet needs, harnessing our proprietary peptide platform to transform treatment possibilities for patients. Parabilis is a clinical-stage biopharmaceutical company dedicated to unlocking high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities.

Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead asset, zolucatetide (FOG-001), is a first-in-class, clinically validated direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in millions of cancer cases annually, including in colorectal cancer, desmoid tumors, hepatocellular carcinoma and a range of other Wnt/β-catenin-driven tumors. In Phase 1 clinical trials, zolucatetide produced the first-ever clinical evidence that it can directly inhibit this interaction, once previously considered “undruggable” despite its role across multiple cancer types. Parabilis is also advancing investigational degraders of ERG and ARON into clinical development for the treatment of prostate cancer, as well as progressing other preclinical programs. Backed by a recent $305 million Series F financing, Parabilis is entering an exciting phase of growth and execution.

What’s the opportunity?

The Vice President, Medical Affairs Oncology is a member of the Development Leadership Team reporting to the Chief Medical Officer. This senior executive leader is accountable for the end-to-end design and execution of the Medical Affairs strategy across Parabilis portfolio, including Scientific Communications, Medical Education, Evidence Generation, Key Opinion Leader (KOL) Engagement, Publication Planning, and Medical Information. This role ensures scientific excellence and cross-functional integration across all development programs and builds a scalable Medical Affairs organization capable of supporting global, multi-indication growth.

Key Responsibilities:

Strategic Leadership

• Define and execute the Medical Affairs Oncology strategy aligned with the clinical development roadmap and portfolio priorities.
• Serve as a core member of the Development Leadership Team and contribute to broader
• Development governance and portfolio decision-making.
• Support portfolio-level medical prioritization, lifecycle planning, and cross-indication strategy.

KOL Engagement & Medical Education

• Build and sustain relationships with leading KOLs, academic medical centers, and cooperative groups relevant to Parabilis’ pipeline.
• Design and oversee Medical Education programs that advance understanding of Parabilis’ science, novel mechanisms, and unmet need across tumor types.

Evidence Generation & Publication Strategy

• Lead the development and execution of a robust evidence generation strategy, including investigator-initiated studies, real-world evidence, and health outcomes research
• Oversee development and execution of a comprehensive publication plan aligned with clinical milestones and regulatory timelines
• Build global medical affairs infrastructure to support multi-program, multi-regional growth
• Drive Medical Affairs KPIs and impact metrics in support of portfolio strategy and commercial readiness

Scientific Communications & Medical Information

• Lead scientific communications strategy to accurately and compellingly convey the differentiated profile of Parabilis’ Helicon™ platform and pipeline assets
• Oversee Medical Information function, ensuring timely, accurate, and compliant responses to healthcare professional inquiries
• Oversee the creation of high-quality medical education materials, slide decks, and scientific exchange resources
• Establish scalable medical affairs infrastructure to support launch readiness across tumor types and geographies

Patient Advocacy and Patient Support

• Building trusted partnerships with advocacy organizations across Parabilis' specific tumor types
• Integrating the patient voice into MA strategy, trial design, and evidence generation
• Collaborating with patient communities on disease awareness and education
• Developing patient support programs to improve access, adherence, and trial participation ensuring all patients’ engagement is conducted with ethical rigor and full compliance

Cross-functional Partnership & Commercial Readiness

• Partner closely with Clinical Development, Regulatory Affairs, and New Product Planning to ensure scientific and medical alignment across the development and pre-commercialization continuum
• Support payer strategies by contributing to value dossiers, HEOR data packages

Compliance & Medical Governance

• Lead development and continuous improvement of Medical Affairs SOPs, governance frameworks, and compliance systems
• Ensure all Medical Affairs activities are executed in accordance with applicable regulations, industry codes, and Parabilis’ internal policies

Organizational Leadership

• Build and mentor a high-performing Medical Affairs Oncology team with deep scientific expertise and strong cross-functional collaboration skills
• Establish clear accountability, performance metrics, and a culture of scientific rigor and integrity
• Foster a culture of collaboration, scientific curiosity, and patient-centricity across the Medical Affairs team

What you’ll need to be successful:

• MD required; PharmD or PhD in a relevant biomedical discipline may be considered with commensurate experience
• 15+ years of progressive biopharmaceutical industry experience, with a minimum of 8 years in Medical Affairs with deep scientific expertise in oncology
• Demonstrated success building and leading Medical Affairs organizations, including KOL engagement, evidence generation, and scientific communications
• Experience standing up Medical Affairs capabilities in high-growth, clinical-stage biotech or pharmaceutical environments
• Strong scientific credibility, executive leadership presence, and ability to engage effectively with both internal and external stakeholders
• High emotional intelligence and track record of cross-functional influence across Development, Commercial, and Regulatory functions

Core Values

Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.

• Growth-Minded. We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
• In(ter)dependent. We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
• Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
• All-In. We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.

The base salary range for this position is $360,000-$410,000 per year, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.

As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

30 Acorn Park Drive    |     Cambridge, MA 02140    |    www.parabilismed.com

Position Summary:

The Senior Director, Commercial Strategy lead is responsible for understanding the evolving needs of the Stargardt community and shaping the brand strategy, including the execution of comprehensive marketing plans. This role will lead brand planning, product launches, and lifecycle management, working closely with cross-functional teams across commercial, medical, regulatory, and clinical functions.

This is a leadership role on the commercial team that will own the go-to-market strategy, lifecycle planning, ensuring seamless collaboration across functions and support market access research ultimately driving meaningful patient impact and delivering strong business results.

Primary Responsibilities:

Brand Strategy & Tactical Execution:

• Develop integrated brand strategies and lifecycle activities to support differentiation and commercialization goals
• Drive disease area strategy, market segmentation, and product positioning based on unmet needs, competitive landscape, and evolving science
• Responsible for creating external (promotional/educational) communication materials for external use with customers (ECPs and Patients)
• Partner with Corporate Communications to support development of the Corp Communications tactics and messages as needed
• Lead the cross-functional workshops for the development of strategic and tactical plans for gildeuretinol

Competitive Strategy and Response:

• Assess emerging trends, market dynamics, and competitive activity to inform commercial decisions
• Lead competitive scenario planning and collaborate with medical, corp. comms, strategic planning and clinical to develop competitive response strategy
• Translate scientific and market insights from ECPs and patients (through market research, ad boards, etc.) into differentiated product strategy and value stories
• Evaluate strategic implications of evolving regulatory, pricing, and access landscapes globally
• Provide input into forecasting assumptions and evaluate ROI for activities
• Collaborate closely with regulatory, medical affairs, market access and corporate communications to ensure alignment of brand vision and execution

Program Team and key workstreams participation:

• Lead development/optimization of TPP
• Generate and communicate ECP/Patient insights to inform Program strategy
• Be the commercial voice on program team and inform decisions impacting commercialization
• Participate in the evidence generation, pubs planning and LCM strategy sub teams to represent the commercial POV

Qualifications:

• Education and Certification
• Advanced degree (MBA) in marketing/ business, or scientific degree preferred
• Requires 12+ years of experience or the equivalent combination of education and experience

• Skills and Key Success Factors:
  • Entrepreneurship spirit with a passion to build, learn and evolve with the team
  • Highly organized and detail oriented with a passion to deliver quality results
  • Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
  • Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
  • Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
  • Evidence of "hands-on" experience and expertise
  • Proven and successful track record as a team-player and collaborator in small working environments
  • Highest levels of professionalism, confidence, personal values and ethical standards

Other Relevant Information:

• Travel:  Able to travel up to 25% of time

Compensation

• Base Salary Range: $235K - $275K, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
• Discretionary Bonus: up to 25% of Base Salary, contingent upon meeting performance components
• Equity: initial grant of incentive stock options
• Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.

About Every Cure:   

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

 Our approach:  

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

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

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

How you will make an impact: 

Strategic Leadership of Clinical Development and Medical Affairs

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

Research and Clinical Development Oversight

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

Portfolio Strategy and Program Management

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

Leadership and Team Development

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

Stakeholder Engagement, Compliance, and Dissemination

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

What you bring to the team:

Education 

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

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

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

Preferred for Vice President designation:

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

Skills 

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

Compensations & Benefits: 

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

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

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

The Role:

Reporting to the Head of Nuvalent Medical Affairs, the Senior Director of Medical Affairs Operations will serve as a strategic thought partner to the Head of Medical Affairs and the Medical Affairs Leadership Team (MALT). This role provides operational leadership, discipline, and alignment across Medical Affairs, ensuring that objectives, processes, and resources are optimized to deliver impact at scale. The incumbent will drive operational excellence, enable cross-functional collaboration, and oversee field operations, insights, and analytics to support the organization’s growth and transformation.

Responsibilities:

• Strategic Partnership & Leadership
  • Act as a trusted advisor to the Head of Medical Affairs and MALT, shaping operational strategy and execution.
  • Drive strong cross-functional team planning and alignment (e.g. MALT, MALT/CLT, Medical Strategy, and IEGT), ensuring smooth ways of working and operational discipline, with seamless execution of strategic priorities.
• Performance Management and Launch Readiness
  • Lead KPI and objectives planning, tracking, and reporting to ensure accountability and transparency.
  • Develop dashboards and reporting frameworks to provide real-time visibility into Medical Affairs performance, risks, and resource utilization; establish frameworks for measuring impact and continuous improvement.
• Operational Excellence and Continuous Improvement
  • Define and evolve ways of working within Medical Affairs, including process development, capability building, and cross-functional orchestration.
  • Drive continuous process improvement and simplification, including SOP development and refinement to ensure scalability and compliance.
• Financial Stewardship
  • Oversee budget planning, forecasting, and resource allocation to ensure fiscal discipline and strategic investment.
  • Partner with Finance to align operational spend with organizational priorities.
• Risk Management & Executive Communications
  • Identify, assess, and mitigate operational risks, ensuring proactive management and transparent escalation to leadership.
  • Craft and deliver executive communications that synthesize operational performance, risks, and strategic initiatives for senior leadership and board audiences.
• Strategic Initiatives and Capability Building
  • Support and enable key initiatives such as regional expansion, organizational transformation, and business model evolution.
  • Support Medical capability building initiatives, ensuring teams are equipped with the skills, processes, and tools to deliver impact.
• Knowledge & Communication
  • Establish central knowledge management systems to ensure accessibility and transparency of information.
  • Facilitate effective team communication and alignment across Medical Affairs and field teams.
• Field Operations & Analytics
  • Provide oversight of field operations, insights generation, and analytics to inform strategy and decision-making.
  • Ensure robust mechanisms for capturing and translating field intelligence into actionable insights.
• Team Facilitation & Culture
  • Foster a high-performance culture through facilitation, coaching, and team development.
  • Enable collaboration, accountability, and continuous learning across Medical Affairs.

Competencies Include:

• Strategic thinker with operational rigor.
• Collaborative leader who builds trust and alignment across diverse stakeholders.
• Skilled in change management and organizational transformation.
• Adept at balancing strategic priorities with tactical execution.
• Committed to fostering a culture of accountability, transparency, and innovation.

Qualifications:

• Advanced degree in life sciences, healthcare, or related field; MBA or equivalent preferred.
• 10+ years of experience in Medical Affairs, clinical development, or related operational leadership roles.
• Proven track record of leading cross-functional teams and driving operational excellence in complex organizations.
• Strong financial acumen with experience in budget management and forecasting.
• Expertise in KPI development, performance tracking, and analytics.
• Exceptional communication, facilitation, and stakeholder management skills.
• Ability to synthesize complexity into clear, actionable frameworks for executive and board-level audiences.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

Reporting to the Director, Global Regulatory Affairs, the Senior Manager, Regulatory Affairs role will integrate regulatory strategic development, submission management expertise, and hands-on execution to support the IND/CTA stage of development through NDA/MAA.

The Senior Manager, Regulatory Affairs will contribute to the development and implementation of regulatory strategy as a member of the global regulatory affairs function and clinical study team(s). This role will manage the process for preparation, submission and internal review and approval of regulatory documents, including providing technical regulatory input for global documents to streamline development.

The Senior Manager, Regulatory Affairs must be kept current, innovative, and compliant with the constant changing Health Authority requirements to facilitate regulatory processes and compliance maintenance from IND/CTAs through NDA/MAA. 

Responsibilities:

• Participates as a regulatory representative for Clinical Study Team (CST) on development programs assigned working closely with product development team (PDT) lead to develop the global regulatory strategy; work closely with regulatory operations and program management to track timelines and ensure deliverables are achieved
• As part of the regulatory clinical study team, you will support preparation, review, compilation, and execution of submissions for regulatory agencies for US and ROW (e.g., IND/CTAs, NDA/MAA, DSURs, Amendments, and Responses to Regulatory Agency Requests for Information, etc.)
• Provide regulatory guidance and support to senior regulatory affairs members on various projects, as needed, to further development programs (pediatric development planning, regulatory interactions, NDA planning)
• Ensure collaboration with and coordination of cross-functional project teams for timely execution of regulatory submissions, maintaining compliance with global regulatory standards and commitments, and providing regulatory guidance and oversight
• Support regulatory operations during the regulatory submissions handoff process, as the primary point of contact for external publishing vendors, ensuring submission packages are accurate, formatted correctly, and validated.
• Maintain the regulatory information system and ensure proper archiving, searchability, and accessibility of regulatory content including correspondence with regulatory agencies
• Manage regulatory submission processes, develop and maintain regulatory tracking tools and infrastructure, as assigned Conduct regulatory intelligence and competitive intelligence and summarize key impacts to global strategy development teams, as appropriate
• Ensure compliance with internal SOPs, regulations and applicable laws. Drafts and reviews Regulatory Affairs SOPs and work instructions and provides Regulatory feedback on other departmental SOPs, where required

Competencies Include:

• Excellent attention to detail and ability to complete efficient and detailed technical data review
• Excellent organization, communication, and multi-tasking skills
• Exceptional interpersonal skills and experience contributing to productive teams and fostering cross functional relationships
• Strong desire to contribute as a member of an engaged and collaborative cross-functional project development team

 Qualifications:

• 6-8 years of experience in Regulatory Affairs or combination of education and direct experience.
• Bachelor or advanced degree in a scientific field or equivalent work experience is required.  Master’s degree a plus.
• Proven experience in evaluation, preparation and compilation of quality dossiers in all required formats and/or experience in regulatory processes.
• Solid understanding of the e-CTD specifications for electronic submissions.
• Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP, ICH Guidelines for CTD/eCTD and CDER requirements for the drug approval process.
• Previous participation in preparing and/or leading regulatory submissions (IND, CTA, NDA, etc.). Experience with preparing meeting packages is a plus.
• Experience in interpretation of regulations, guidelines and precedents related to drug development in the US and EU.
• Strong understanding of regulatory eCTD structure and clinical trial conduct and design
• Proficiency with electronic submission publishing software and document management information systems (i.e., docuBridge, Veeva Vault RIM)
• Ability to plan, prioritize and contribute to work and projects in a systematic and efficient manner with emphasis on streamlining processes

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

Reporting to the Senior Medical Director, Pharmacovigilance, the Associate Medical Director, Drug Safety and Pharmacovigilance is responsible for the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. The individual will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This individual is expected to provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., DSURs, PSUR and clinical safety assessments). The individual will be an integral part of a group of safety professionals within Nuvalent and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

Responsibilities:

• Provide medical expertise in the assessment of ICSRs
• Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports
• Contribute to signaling and safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signals
• Serve as a medical resource for the generation and review clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs) and the development of Reference Safety Information
• Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documents
• Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents
• Provide safety and pharmacovigilance training programs as required
• Collaborate cross functionally (e.g. Reg Affairs, Clin Ops, Clin Science) to ensure pharmacovigilance input
• Support other pharmacovigilance and drug safety responsibilities as assigned

Competencies Include:

• Strong written/verbal communication skills.
• Ability to work in a collaborative environment and build effective working relationships across the organization, and with external stakeholders/vendors
• Detail and process orientated, with excellent project management, problem solving, and organization skills.
• Ability to think critically with strong attention to detail.
• Demonstrated project management and prioritization capabilities

 Qualifications:

• 4+ years’ experience in Drug Safety / Pharmacovigilance in a Biotech / Pharma company
• 8+ years of industry (Biotech / Pharma) experience
• Healthcare degree required / Medical Degree (MD) from recognized medical school preferred.
• Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
• Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities
• Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.
• Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment)
• Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER)
• Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval
• Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels
• Ability to build relationships, collaborate and influence across disciplines within Nuvalent and with outside stakeholders
• Experience with MedDRA coding, Points to Consider, AoSE, and SMQs
• Excellent verbal, written and presentation skills

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

Reporting to the Head of PV Science, the Associate Director, Drug Safety and Pharmacovigilance Scientist is responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This individual is expected to provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., DSURs, PADERs, PBRERs, and clinical safety assessments). This individual may also support the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. The individual will be an integral part of a group of safety professionals within Nuvalent and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

Responsibilities:

• Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports
• Contribute to signaling and safety surveillance processes, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signals
• Serve as a medical resource for the generation and review of clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs) and the development of Reference Safety Information
• Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documents
• Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents
• Provide safety and pharmacovigilance training programs as required
• Collaborate cross functionally (e.g., Reg Affairs, Clin Ops, Clin Science) to ensure pharmacovigilance input
• Support the medical assessment of ICSRs as needed
• Support other pharmacovigilance and drug safety responsibilities as assigned

Competencies Include:

• Design global risk management frameworks for Nuvalent’s medicines
• Translate safety data into clinical insights
• Adapt visualization tools for safety surveillance
• Influence multidisciplinary teams to prioritize patient safety.
• Strong ability to build relationships, collaborate and influence across disciplines within Nuvalent and with outside stakeholders

Qualifications:

• 4+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
• 7+ years of Pharma / CRO experience. 
• Degree in a medical or healthcare related discipline like MD, PharmD, RN or PhD.
• Excellent knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
• Experience with medical drug safety assessments, drug safety surveillance and monitoring activities
• Experience with safety data collection and interpretation from clinical trials, literature and post market
• Experience with preparation of responses to Regulatory Authorities and experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval
• Experience with the development and updates to Reference Safety Information, IB, Company Core Data Sheet and local labels
• Excellent verbal, written and presentation skills

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

What if... We could harness the power of Flagship’s scientific platforms and create novel treatment options that benefit more patients, sooner?

Pioneering Medicines (PM), an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship's scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines’ approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments.

Position Summary:

We are seeking an Executive Director, CMC (Chemistry, Manufacturing & Controls) with a proven track record of driving portfolio-level CMC strategy and execution across multiple emerging modality programs simultaneously. This is a senior leadership role operating at the intersection of science, strategy, and operations—requiring the ability to set direction across a complex multimodality pipeline, and build CMC function as a competitive advantage for Pioneering Medicines. This position reports to the SVP, CMC & Technical Operations.

This role will serve as the strategic and operational owner of CMC across the full PM portfolio from research interface through early and late clinical development. This leader will be equally comfortable shaping long-range CMC strategy at the portfolio level and resolving complex technical challenges at the program level. They will define how PM approaches emerging modalities, build and leverage a best-in-class external Contract Development and Manufacturing Organizations (CDMO) network, combined with the strategic acumen to make portfolio-level resourcing decisions. They will be a thought leader in innovative approaches and champion adoption of AI-enabled CMC tools.

Responsibilities:

• Serve as a key member of the Technical Operations leadership team. Lead CMC functions including Drug Substance Development, Drug Delivery / Pre-formulation, Analytical Development, Product Development and Regulatory CMC. Accountability for all aspects of CMC functional strategy and portfolio deliverables.
• Responsible for building and scaling the CMC organization and defining its strategic direction. Recruit, develop, and retain a high-performing CMC team; invest in talent and cultivate a culture of excellence, accountability, and continuous improvement
• Own and drive end-to-end CMC execution across an increasing portfolio of multimodality compounds, ensuring programs advance on time and on strategy; accountable for portfolio-level CMC risk identification, prioritization, and mitigation
• Build and manage a high-performing external CDMO network in partnership with VP, CMC Operations. This includes selection, assessment and establishment of strategic relationships; Maintain a forward-looking view of the CDMO landscape to anticipate portfolio capacity and manufacturing needs
• Oversee the identification, evaluation, and implementation of novel technologies and innovations to drive greater program / portfolio value. Leverage emerging AI-driven technical development, manufacturing and advanced analytics approaches to accelerate CMC timelines and improve efficiency across the portfolio
• Engage and align key stakeholders across Technical Operations, Research, Translational Medicine, and Regulatory Affairs to establish CMC development paradigms, resolve cross-functional trade-offs, and ensure portfolio decisions reflect both scientific rigor and operational reality
• Oversee CMC handoffs and establishing fit-for-purpose development and manufacturing pathways for novel modalities originating within the FSP ecosystem. Act as CMC strategic advisor, as needed
• Serves as an ambassador of PM for external stakeholders and industry as a whole

Requirements:

• PhD in a relevant scientific discipline with 15+ years of progressive CMC experience (MS with 18+ or BS with 20+ considered); Minimum 5 years in senior leadership with direct accountability for CMC strategy across multiple simultaneous programs
• Deep hands-on expertise in small molecules and biologics. Expertise is preferred (but not required) in advanced modalities incl. nucleic acids, cell or gene therapies
• Demonstrated track record of filing and defending regulatory dossiers (INDs, CTAs, BLAs/NDAs, or MAAs) across multiple programs and modalities; Current working knowledge of global regulatory expectations (FDA, EMA, PMDA) and direct experience in agency interactions on CMC topics.
• Proven ability of owning CMC strategy and execution across a multi-program portfolio simultaneously, including developing and managing CMC budgets, risk management, and delivery against aggressive timelines
• Extensive experience identifying, selecting, contracting, and managing CDMOs and CROs with specialized emerging modality capabilities, including leading technology transfer and resolving technical challenges at external sites
• Thought leadership in innovation, including novel delivery, high-throughput process development, and platform-based approaches to elevate program / portfolio value
• Strong understanding of AI/ML, digital process development tools, and data-driven manufacturing platforms to improve development speed and efficiency
• Executive presence and demonstrated ability to influence and align cross-functional PM and platform company leaders; Strong communicator who can translate complex CMC strategy and risk for non-specialist audiences
• Experience partnering with GxP Quality to establish quality systems appropriate for a development-stage organization, including SOPs, change control, and deviation management in a GxP environment
• Entrepreneurial builder energized by creating structure in ambiguous, fast-moving environments; high accountability orientation with a bias for action and the ability to make sound decisions with incomplete information
• Collaborative, low-ego leadership style with genuine investment in team development and cross-functional relationships

About Flagship 

Flagship Pioneering is a scientific innovation engine that invents and builds companies that change the world. We bring together the greatest scientific minds with entrepreneurial company builders and assemble the capital to allow them to take courageous leaps in human health, sustainability, and beyond. 
 
What sets Flagship apart is our ability to advance biotechnology by uniting life science innovation, company creation, and capital investment under one roof in a way that is largely without precedent. Our team of scientists, entrepreneurial leaders, and professional capital managers are each aligned around an institutionalized process that enables us to innovate and create breakthroughs for the benefit of people and planet. 
 
 Many of the companies Flagship has founded have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture. Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies, and has been named four times to Fast Company’s annual list of the World’s Most Innovative Companies. 

At Flagship, we recognize there is no perfect candidate. If you have some of the experience listed above but not all, please apply anyway. Experience comes in many forms, skills are transferable, and passion goes a long way. We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto. 

The salary range for this role is $228,000 - $313,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Pioneering Medicines currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Pioneering Medicines's good faith estimate as of the date of publication and may be modified in the future.

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. We are seeking an accomplished and strategic Senior Director, Regulatory Affairs to shape global clinical regulatory strategy across our pipeline, with a particular focus on programs in Type 1 diabetes, oncology, and autoimmune disease. This role is ideal for a seasoned regulatory leader who is excited by science‑driven development, cross‑functional collaboration, and advancing therapies for serious diseases.

You will develop and execute comprehensive regulatory strategies for clinical‑stage programs, guide teams on global regulatory requirements, and help shape the long‑term regulatory vision for the portfolio from Phase 1 to commercialization. Clinical-stage regulatory experience in our therapeutic areas of focus (Type 1 diabetes, oncology, autoimmune disease) and cell/gene therapies is preferred. Experience in regulatory operations and/or ex-US submission planning are also considered beneficial for the role. This position reports to the Vice President, Head of Regulatory Affairs and would work out of Sana’s offices in Cambridge (preferred), South San Francisco, or Seattle.

What you’ll do

• Direct clinical regulatory strategies for assigned programs, with emphasis on Type 1 diabetes, oncology, and autoimmune disease assets.
• Create regulatory development plans, including key milestones, registration strategies, health authority engagement plans, expedited pathways, pediatric development, and risk assessments.
• Partner closely with Clinical Development, CMC Regulatory Affairs, Clinical Operations, Safety, Technical Operations, and Program Leadership.
• Lead and/or oversee global regulatory submissions and health authority interactions/meetings.
• Provide strategic input into labeling, target product profiles, and benefit‑risk considerations.
• Serve as a senior regulatory representative on cross‑functional program teams.
• Lead regulatory operations improvement efforts to ensure submission quality, compliance, and efficiency.
• Proactively identify regulatory risks and mitigation strategies.
• Monitor evolving regulatory policy in Sana’s therapeutic areas of focus and for cell/gene therapy modalities.
• Support development of internal regulatory processes.
• Mentor junior regulatory staff.

What we’re looking for

• Bachelor’s degree required, advanced degree in relevant scientific field preferred.
• 10+ years of regulatory affairs experience in biopharmaceutical industry; experience with cell and/or gene therapy products highly desirable.
• Demonstrated success in preparing and leading IND/CTA submissions, pivotal-stage amendments, BLA/MAAs, and any associated regulatory interactions.
• Clinical-stage regulatory experience in Sana’s therapeutic areas of focus (Type 1 diabetes, oncology, autoimmune disease) and cell/gene therapies preferred.
• Demonstrated ability to lead regulatory strategy through complex decision points and influence cross-functional teams at the senior level.
• Demonstrated ability to collaborate productively across a broad array of functional areas, as well as raise and entertain different points of view and regulatory options.
• Experience in regulatory operations, and/or ex-US submission planning beneficial, though not required.
• Strong understanding of FDA, EMA, and international guidelines.
• Excellent oral and written communication skills.
• Ability to work from Sana offices in Cambridge, MA is preferred; will consider candidates who can work from our offices in South San Francisco, CA or Seattle, WA.

What will separate you from the crowd

• Deep motivation to advance therapies for people with serious unmet needs.
• Intellectual curiosity and scientific rigor.
• Strong skills in matrix leadership, influencing without direct authority

What you should know

• The base pay range for this position at commencement of employment is expected to be between $275,000 and $325,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience 

We are seeking an MBA Marketing Intern for a 3-month summer internship who thrives in a high-growth, fast-paced environment. This role will support the Marketing team while gaining exposure to a wide range of strategic and executional marketing initiatives. This is a highly cross-functional role, working closely with Operations, Product, Commercial, Medical Affairs, and Brand/Creative teams. Reporting to the Head of Marketing, you will contribute across multiple areas, including messaging and positioning, content development, campaign execution, customer insights, digital marketing, and brand strategy.

Specific Duties

• Own & Deliver a Marketing Capstone Project

• Lead a high-impact marketing project from scoping through execution and final presentation

• Partner with cross-functional stakeholders to define objectives, synthesize insights, pilot the program, track learnings, and deliver actionable recommendations

• Present findings to leadership at the conclusion of the internship

• Support Marketing Campaigns & Execution

• Assist in building and executing integrated marketing campaigns across channels

• Support white-glove in-person or digital event planning 

• Support content creation efforts, including thought leadership, sales enablement materials, and digital assets

• Support Customer & Market Insights

• Conduct market research, competitive intelligence, and customer analysis

• Synthesize secondary research to inform strategy and decision-making

• Support Marketing Operations & Performance

• Assist in tracking campaign performance and marketing KPIs

• Help maintain marketing systems, processes, and reporting frameworks to improve team efficiency

• Support Web, Digital & Social Media

• Contribute to website updates, SEO/SEM initiatives, and digital content optimization

• Support social media planning, content development, and performance tracking

We Value GRIT, So You’ll Fit In if:

• G — Growth: You are an avid learner and challenge yourself 

• R — Responsibility: You take immense pride in your work and follow through on your work, small or large 

• I — Impact: You are excited to roll up your sleeves and work on projects with true business meaning, and not just observe

• T — Team: You collaborate and communicate effectively with team members of different backgrounds and perspectives

Required Qualifications 

• Bachelor's degree in marketing, business, or a related field required

• Active MBA student pursuing Masters in Marketing, or related field 

Preferred Qualifications

• Familiarity with CRM and marketing automation tools, especially HubSpot

• Prior experience in healthcare

Travel: 

• Location: Hybrid role at Cambridge, MA headquarters 

• No other travel anticipated 

Our Opportunity...

We are looking for a highly motivated Associate Director of Data Management. As a key contributor within the Clinical Operations team, you’ll be responsible for leading the entire data lifecycle at the program level for development of our first clinical stage autologous cell therapy program targeting solid tumors. 

You will be responsible from study startup to database lock for multiple clinical studies developing engineered TIL cell therapies for certain solid tumor indications, oversee end-to-end clinical data strategy, ensuring high-quality, regulatory-compliant data (e.g., SDTM/CDISC) from study startup to lock. 

You will be a vital part of a highly collaborative team working to achieve Obsidian’s vision by collaboratively translating innovative science into medical breakthroughs for patients starting with our lead program OBX-115, a novel engineered tumor-infiltrating lymphocyte (TIL) therapy.  

This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. 

This is a Hybrid role based out of Bedford or Cambridge, MA locations.  

You Will...

Core responsibilities

• Manage all clinical data management (CDM) activities, serving as the primary point of contact for CROs and vendors, ensuring studies are delivered on time, within budget, and in compliance with ICH-GCP  
• Actively represent Data Management in study team meetings, leadership forums, and regulatory audits 
• Provide expertise in database setup, CRF design, and development of data management strategy to ensure high-quality, submission-ready data  
• Develop data management plans (DMPs) and provide technical guidance on clinical database structures to internal teams and external partners  
• Ensure all clinical data, including AE and SAE data, complies with CDISC standards (CDASH/SDTM) and is prepared for FDA and EMA submissions  
• Oversee data cleaning, discrepancy management, and reconciliation of third-party data sources (e.g., central labs, IRT)  
• Collaborate with Programming to implement internal data quality checks and support ongoing data review activities  
• Partner with Clinical Operations, Biostatistics, Medical Monitoring, and Regulatory Affairs to define data standards, assess data quality, and resolve queries  
• Ensure integration of data across clinical and manufacturing systems, including specialized tracking such as scalpel-to-vein processes for TIL therapy  
• Manage vendors and ensure appropriate resourcing to support clinical trial execution  
• Coordinate CDM deliverables across internal and external cross-functional teams  
• Collaborate with Supply Chain and Logistics to oversee tracking of manufacturing data  
• Work with Standards, Quality, and Compliance teams to develop and implement data standards and drive continuous process improvement  
• Develop and refine standard operating procedures (SOPs)  
• Apply strong project management, organizational, and interpersonal skills to support successful study execution 
• Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes  
• Self-motivated, with a proven ability to meet objectives and timelines, managing multiple responsibilities in parallel.    
• Flexible - adapts to change in a fast paced, rapidly developing environment  
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner  
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments 

You Bring...

Core Qualifications

• Education: Bachelor's Degree in life sciences, mathematics, or related field; with 10+ years of progressive experience in a biopharma setting, or a master's degree with 8+ (Master’s preferred). 
• Experience: 6 - 8+ years of experience in clinical data management, including significant experience in oncology, and ideally in cell therapy. 
• Systems: Proficiency in electronic data capture (EDC) systems, particularly Medidata Rave. 
• Technical Knowledge: Strong understanding of CDISC, SDTM, CDASH, and ICH-GCP regulations. 
• Leadership: Proven ability to manage CROs and lead cross-functional teams. 
• Excellent planning, coordination, and time management skills   
• Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.   
• Ability to build and maintain productive relationships with colleagues within the clinical team, across the Obsidian organization, and with external partners.   

Company Overview 

Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s lead program in clinical development is Pociredir, a small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease (SCD).

Description

Reporting to VP of Biometrics, the Director of biostatistics within the Biometrics Department is a hands-on role and is expected to be the statistics subject matter expert for clinical development programs and studies, including oversight of statistical activities in outsourced clinical trials, while ensuring adherence to all regulatory requirements. This individual is expected to have an in-depth understanding of innovative study designs and statistical methodologies, including estimand strategies, endpoint selection, missing data and multiplicity handling. In addition, this individual will have the capacity to understand the relevant multi-disciplinary knowledge and interact effectively within the biometrics department and with clinical development, clinical operations, pharmacovigilance, medical writing, and regulatory affairs.

Responsibilities

• Function as a lead statistician for internal studies.
• Contribute to enterprise strategy through proactive cross-functional collaborations and influence through decision making.
• Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address statistical questions from regulatory agencies.
• Conduct ad-hoc analyses as needed.
• Provide oversight of biostatistics activities in outsourced clinical trials.
• Ensure high quality, timely delivery of statistical analysis plans and statistical outputs.
• Execute quality assurance procedures on work produced by others, ensuring statistical analysis is being done according to specifications.
• Provide support for publications as needed.
• Author or review statistical SOPs and Working Instructions.

Qualifications

• A Ph.D. (or equivalent degree) in Biostatistics or Statistics with a minimum of 8 years of relevant clinical biostatistics experience in pharma, biotech or CRO industry -OR- a Master's degree and a minimum of 10 years of relevant industry experience is required.
• Comprehensive knowledge of innovative study design and statistical methodologies.
• Extensive knowledge of relevant clinical and statistical regulatory requirements (e.g., GCP, ICH, CDISC, etc.).
• Regulatory interaction and submission experience is highly preferred.
• Experience in oversight of biostatistics activities in outsourced clinical trials is highly preferred.
• Proficiency in statistical software (e.g., SAS, R) and simulation.
• Excellent verbal and written communication skills.
• Ability to work collaboratively in a multidisciplinary team environment.

Join Cartwheel to help tackle the student mental health crisis!

Cartwheel is an early-stage company building a new kind of mental health program for kids that puts schools at the center. We see our role as supporting school staff who see kids every single day. Instead of going around them, we collaborate with them. This means: 

• Earlier intervention
• Higher student and family engagement in care
• Better coordination among the trusted adults in a student’s life 

Kids shouldn't just aspire to get out of bed and drag themselves to class. They should be able to experience joy. They deserve to envision and build a life they’re excited to live. If you join Cartwheel, you’ll help make this vision a reality for millions of students across the country. We’re backed by top investors including A Street Ventures, Menlo Ventures, Reach Capital, General Catalyst, BoxGroup, and Able Partners, and we're looking for mission-driven teammates to join our team.

ABOUT THE ROLE

In 3 years, Cartwheel has grown to serve more than 325 school districts in 16 states, making us the nation’s largest mental health provider that collaborates with K-12 schools. With billions of dollars in new state and federal investments in youth mental health coming in 2026, we are supplementing our district-level sales motion with statewide partnerships with Governor’s offices, education departments, and health agencies.

As the Enterprise Customer Success Manager, you will be Cartwheel's primary point of contact with the state agency, responsible for turning a signed contract into a high-impact, expanding program. That means building the implementation plan, coordinating execution across Cartwheel's internal teams, keeping agency staff informed and confident, and clearing whatever is in the way of delivering exceptional impact. Throughout the contract period, you’ll partner closely with our Government Relations teams, which will own executive and legislative relationships and the contract renewal process.

Role type: W2, Full-Time, Salaried position
Salary range: $143,000 – $187,000 OTE (10% variable pay included) plus competitive equity package
Location: Remote
Target Start: June 2026

WHAT YOU'LL DO

Own the state agency relationship

• Be the primary Cartwheel contact for agency program directors, behavioral health leads, and operational staff — the people responsible for implementing the partnership. 
• Build a deep understanding of agency priorities, constraints, and decision-making so you can navigate complexity and keep things moving
• Develop and maintain a comprehensive contact map across agency implementers, influencers, and financial buyers — and build productive relationships across each layer
• Lead regular agency check-ins covering progress, milestone tracking, and issue resolution
• Navigate agency political dynamics, policy constraints, and interagency complexity
• Develop success stories as implementation matures to support renewal and expansion

Drive implementation

• Build and own the implementation plan for your state(s): What needs to happen, in what order, by when, and who is responsible
• Develop a district prioritization framework: Where to start, how to sequence expansion, how to pace growth against contract timelines
• Own and track the metrics that matter — utilization, district activation, contract milestone attainment — and surface risks early before they become problems
• Coordinate across internal Cartwheel teams to ensure we meet all of our impact goals and milestones. For example:
• Partner with the Government Relations team on renewal readiness and ensure they have an excellent value story to share with executive and legislative buyers
• Ensure district-level sellers and CSMs are effectively onboarding districts
• Coordinate with Operations to clear compliance, credentialing, and regulatory hurdles that slow implementation down

• Engage state-level professional associations (superintendent associations, state education agencies) to support district activation and strengthen Cartwheel's presence

Keep leadership and the team aligned

• Maintain clear, multi-quarter visibility into contract health and district-level risk
• Report out on contract health to Senior Leadership and share insights on how to improve our approach to state implementations, product innovation, or other key insights
• Identify expansion opportunities (new districts, expanded services, adjacent agency relationships) and surface them to Government Relations and internal teams to pursue

WHAT WE’RE LOOKING FOR

Required

• 7–10+ years in customer success, strategic account management, or a closely related post-sale role, with meaningful experience in government or public sector
• You're an exceptional communicator — able to translate operational complexity into clear reporting for agency partners and internal leadership
• You've built trusted relationships with state or government agency staff. Not just executives, but program officers and operational leads
• You've managed complex, multi-stakeholder account plans and can connect the dots between day-to-day execution and long-term contract health
• You understand the revenue implications of implementation decisions and take ownership of retention outcomes
• You can navigate political and bureaucratic dynamics without losing momentum
• You are comfortable interpreting data on your own and communicating insights
• You're highly organized and comfortable building structure in an environment that doesn't have all the answers yet

Preferred

• Experience in K–12 education, healthcare, or direct service businesses
• Familiarity with braided funding models (state contracts, Medicaid, grants, district fees)
• Background working alongside or within Government Relations or public affairs functions
• Experience with state procurement processes and compliance relevant to public sector
• Familiarity with ChurnZero, Gainsight, Salesforce, or HubSpot

Travel

This role requires regular travel — approximately 40% — to support state agency relationships, district engagement, and key implementation milestones, concentrated in your assigned state(s).

Please apply even if you don't meet all of the criteria. If your past experience doesn't perfectly match the job description, but you bring other relevant experience or skills, we'd still love to hear from you. You may be a great fit!

WHY YOU’LL LOVE CARTWHEEL

Our hope is that Cartwheel will be your best career decision! In addition to tackling one of the biggest challenges of our time, at a company well-positioned to do so, you'll have:

• Mission-oriented and inclusive colleagues who will go to bat for you
• Competitive compensation
• Generous PPO medical, vision, and dental/ortho coverage
• Life Insurance
• Generous paid time off, including company closure from Christmas-New Years (12/25-1/1)
• Paid holidays and sick leave
• Paid parental leave
• 401K with employer match
• Meaningful equity ownership stake in Cartwheel
• Flexible and remote role with regular in-person retreats
• Annual learning stipend
• Laptop 

Position Overview:

Beam is looking for a highly motivated and experienced Insights & Analytics leader to expand our commercial capabilities as we advance our portfolio toward potential commercialization.  The Director, Insights & Analytics will lead the development and execution of market insights, forecasting, and competitive intelligence capabilities across Beam’s portfolio. This role will serve as a strategic partner to Marketing, Market Access, Patient Operations, Medical Affairs, and Portfolio Strategy to translate key business questions into actionable insights that inform decision-making across the product lifecycle.  In addition, the Director, Insights & Analytics will directly support early pipeline assets, e.g. provide market sizing, competitive landscape analyses, drivers for therapy and brand choice.

This position requires both strategic thinking and hands-on execution in a fast-moving, cross-functional environment.

Responsibilities:

Market Insights & Research Leadership

• Build and lead market research capability across the portfolio.
• Partner with Marketing, Market Access, Medical Affairs, and Portfolio Strategy to define key business questions.
• Recommend appropriate market research methodologies and lead RFP processes and vendor selection for market research projects.
• Manage external research partners and ensure high-quality execution.
• Develop initial discussion guides, surveys, and stimuli in collaboration with cross-functional teams.
• Synthesize research findings into clear, actionable insights and facilitate cross-functional sharing.

Forecasting & Analytical Support

• Lead forecasting processes across the portfolio, including:
• Patient flow and demand models
• Market uptake scenarios
• Sensitivity analyses and risk scenarios
• Develop and maintain analytical tools and models to support asset-level and portfolio-level decision making.

Competitive Intelligence

• Establish and lead competitive intelligence processes across the portfolio.
• Monitor competitive clinical, regulatory, and commercial developments.
• Manage external CI vendors and spearhead CI strategy and coverage for conferences.
• Synthesize competitive insights into implications for strategy, positioning, and planning.
• Support scenario planning and strategic trade-off discussions.

Early Pipeline & Portfolio Analyses

• Support early-stage assets with:
• Epidemiology and market sizing
• Competitive landscape assessments
• Unmet need and treatment paradigm analyses
• Possibly facilitate early asset TPP generation.

Qualifications:

• BS/BA in a relevant academic field; MBA, MD, PhD, or other graduate degree strongly preferred
• 15+ years business experience within the pharma/biotech/biopharma space or consulting
• Experience in cell and gene therapy is strongly preferred.
• Strong understanding of primary and secondary market research methodologies.
• Proven experience leading vendor selection and managing research partners.
• Must be capable of managing and prioritizing multiple activities.
• Hands-on forecasting experience, including scenario planning, strongly preferred.
• Ability to synthesize complex data into clear strategic insights.
• Strong cross-functional collaboration skills.
• Comfortable operating in ambiguity and building new processes from scratch.
• Excellent communication and executive presentation skills.
• Role is based in Cambridge, MA.
• Onsite requirements: Candidates are expected to come onsite 1-3 days per week.
• Ability to travel 25% as needed.

The Opportunity

The Senior Director of Patient Services will play a critical role in shaping how Amylyx supports patients throughout their treatment journey. This leader will design, build, and launch a best-in-class patient support program for our lead product candidate, ensuring that it reflects a commitment to supporting patient access, community education, and operational excellence.

This individual will bring strategic vision and hands on leadership to create an integrated support program—from access and reimbursement solutions to patient education and continued on-treatment support. As a key leader in the commercial organization, this individual will partner with colleagues across market access, sales, and marketing, as well as cross functionally, to ensure a seamless and high impact customer experience that helps people start and continue treatment.

This is a unique opportunity to define a foundational capability at Amylyx and set a new standard for patient access support.

Responsibilities

Program Design

• Design a comprehensive, patient‑centered services model tailored to the unique needs of the communities we serve
• Define the strategic framework, service offerings, operational workflows, and end‑to‑end experience for patients, caregivers, and providers, ensuring alignment with the current market access landscape across reimbursement, technology, and delivery models
• Optimize the program by determining the appropriate balance of insourced versus outsourced services and planning for program evolution over time

 Operations Leadership

• Lead end‑to‑end patient support operations, including financial assistance, benefits verification, case management, adherence, nursing, and injection training
• Build, hire, and lead high‑performing internal and field‑based patient access and service operations teams
• Evaluate, contract, and manage third‑party service providers, ensuring strong governance, performance accountability, and alignment with business objectives
• Establish compliant oversight across hub services and all patient‑facing operations in close partnership with Legal, Compliance, and Medical Affairs
• Define KPIs, dashboards, and feedback loops to drive performance, transparency, and continuous improvement across service operations
• Serve as the operational lead for launch readiness and ongoing execution by identifying access barriers, leading cross‑functional issue resolution, and aligning with Commercial, Market Access, Sales, Medical Affairs, IT, and National Accounts teams

Required Qualifications

• Bachelor’s degree required, advanced degree in a related health or business field preferred
• 12+ years of experience in biopharmaceutical patient support services, including product launch and rare disease product access
• Proven track record designing, launching, and managing hub services, reimbursement support, and financial assistance programs
• Expertise in U.S. payer specialty drug coverage, reimbursement mechanics, and specialty pharmacy operations
• Proficiency in analytics and reporting for service programs and pharmacy data
• Knowledge of compliance and regulatory requirements for patient support programs
• Ability to communicate program objectives, launch plans, and performance effectively to internal stakeholders
• Proven people management experience, including hiring, coaching, and developing teams
• Demonstrated leadership of cross‑functional teams in fast‑paced, launch‑focused environments
• An unwavering dedication to patient access and empowering the teams responsible for delivering it

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

Position Overview:

Beam is seeking a dynamic, visionary, and strategic Senior Director, Global HEOR to spearhead the global HEOR strategy for our sickle cell disease program (risto-cel) and other pipeline programs as they emerge . In this high-impact role, the Senior Director, Global HEOR will develop and execute evidence-generation plans, manage stakeholder relationships, and shape external communication strategies. You will partner closely with Clinical Development, Medical Communications and Scientific Publications, Value and Evidence Strategy, Commercial, R&D, and additional cross-functional teams. If you thrive in a collaborative, mission-driven environment and are eager to shape the future of sickle cell disease care, we want you to bring your expertise and passion to Beam.

Responsibilities:

• Provide strategic input to disease prioritization, target product profiles, clinical trial protocols, clinical development plans, and regulatory submissions; lead development of clinical sections for Investigator’s Brochures, briefing books, safety updates, IND/NDA materials, and responses to Health Authority questions. 
• Develop, validate, and integrate patient‑centered outcomes (PROs) into protocols and analyses.
• Interpret clinical trial results (including PROs and healthcare resource use) and partner with Clinical Development/Biostatistics on Statistical Analysis Plans (SAPs) and post‑hoc analyses.
• Lead a fit‑for‑purpose RWE strategy (EHR, claims, registries, hybrid/open datasets) including natural history/registry design and governance to inform endpoints, recruitment, and post‑authorization effectiveness/safety assessments.
• Develop and operationalize external/synthetic control arm approaches (e.g., matched registry cohorts, Bayesian borrowing) for single‑arm or small‑population studies typical in cell & gene therapy.
• Provide operational oversight of Medical Affairs evidence generation, including vendor/CRO governance, milestone/deliverable tracking, data‑quality plans, risk management, and on‑time execution across Medical Affairs–led studies; contribute to long‑term capability building (digital health, real‑world studies).
• Elicit and integrate perspectives from patients, KOLs, policy leaders, and internal stakeholders (market access, marketing, patient advocacy) to ensure plans meet the needs of patients, HCPs, and payers.
• Support Market Access on internal and external payer/policy initiatives (pricing and reimbursement, unmet medical need, regional market dynamics, evidence gaps) across the portfolio.
• Support business decisions around ex-US strategy including, but not limited to, scoping ex-US opportunities, prioritizing country engagement, early scientific advice / parallel consultations with EMA and HTA bodies (e.g., HTACG/JSC), providing advice to development programs on endpoint selection to support product and reimbursement approvals ex-US, etc. 
• Anticipate payer evidence needs and budget‑impact critiques (including preparation for ICER Reviews). 
• Build and maintain economic models (cost‑effectiveness, budget impact) tailored to one‑time CGTs, addressing uncertainty/durability and caregiver burden. 
• Collaborate with Market Access to design innovative payment models and outcomes‑based agreements with pragmatic outcomes and tracking. 
• Lead the AMCP dossier and pre‑approval information exchange (PIE) strategy (6–12 months pre‑launch). 
• Work collaboratively with internal teams, consultants, and CROs to advance development of the portfolio. 

Qualifications:

• Master’s Degree or higher in Health Economics and Outcomes Research or a relevant discipline.
• Formal training in Epidemiology/Health Services Research required.
• At least 10+ years’ experience in observational research study management AND data analytics, either within industry or with an observational research consulting firm.
• Proven track record in drug development, with rare disease experience and an existing network of hematologists preferred.
• Demonstrated ability to lead in a matrixed, cross-functional environment, combining strategic agility with strong business acumen.
• Independent, proactive operator with strong ownership.
• Cross functional collaboration with Clinical, Regulatory, Commercial, Medical Operations, and Publications while maintaining medical/scientific integrity.
• Excellent communication, collaboration, and problem-solving skills.
• #LI-Hybrid 

Position Overview:

Beam Therapeutics is seeking a highly skilled attorney to serve as the Corporate Counsel/Senior Corporate Counsel, Commercial Contracts. This role will partner with Beam’s medical affairs, commercial and manufacturing teams to provide contracting support for Beam’s transition to a commercial stage company. Ideal candidates will excel in negotiating complex agreements, managing risk, and achieving business objectives in a fast-paced, cutting-edge biotechnology company.

Responsibilities:

• Draft and negotiate high-stakes agreements in support of Beam’s anticipated product launches, including complex commercial contracts with gene therapy treatment centers, channel partners and manufacturers.
• Assist with legal review of other pre-commercial activities, including advisory boards, patient engagement events, patient support programs, market access activities, speaker programs, and market research.
• Provide legal support to Beam’s various promotional material review committees.
• Provide ongoing contracting support and lifecycle management, including agreement interpretation and risk analysis, for Beam’s commercial, medical affairs, manufacturing and other teams.
• Collaborate with business teams and subject matter experts on continuous review and updates of Beam contracting playbooks and standards.
• Draft and negotiate a range of other key agreements in support of Beam’s broader business, including clinical trial agreements, material transfer agreements, sponsored research agreements, service provider agreements, and non-disclosure agreements.

Qualifications:

• Juris Doctor (JD) from an accredited law school; admission to practice in at least one U.S. jurisdiction.
• 5+ years of experience with complex biotechnology contracting, ideally with commercial-stage cell and gene therapy companies.
• Ability to manage multiple, overlapping, high-stakes agreements to completion on tight timelines.
• Flexible, must be able to work collaboratively with team members for a diverse range of projects.
• High degree of professional ethics and integrity.
• Sound judgement and ability to quickly analyze different sources of information.
• Practical and business-minded, capable of recognizing, assessing, and responding to urgent matters with timely, pragmatic, and clear solutions.
• Exceptional and demonstrated written and verbal communication skills.
• Candidates are expected to come onsite 2 days per week.

Additive Qualifications:

• Experience advising medical affairs and commercial teams on legal and regulatory legal requirements related to product launches.
• Ability to provide legal counsel on health care laws, such as anti-kickback, false claims and transparency statutes.
• Service on promotional material review committees for pre-commercial or commercial biotechnology companies.

Position Summary:

The Senior Clinical Scientist is responsible for providing scientific leadership and oversight for late-stage (Phase 3) clinical development programs in rare disease ophthalmology. This role plays a critical part in ensuring the scientific integrity, regulatory readiness, and successful execution of pivotal clinical trials intended to support global registration.

As a senior individual contributor, the Senior Clinical Scientist serves as a core scientific partner across clinical development, working closely with clinical operations, biostatistics, regulatory affairs, and safety to translate strategy into executable, high-quality Phase 3 studies. This role is well-suited for an experienced hire with demonstrated success in late-stage clinical development within rare disease and/or ophthalmology.

Primary Responsibilities:

• Provide scientific leadership for Phase 3 clinical trials, including contributions to overall clinical development strategy, study design, endpoint selection, and patient population definition, with a focus on rare disease and ophthalmology indications.
• Lead or co-lead the development of pivotal study protocols, informed consent forms, and key scientific sections of regulatory documents, ensuring alignment with global regulatory expectations (FDA, EMA, and other health authorities).
• Serve as the scientific point of contact for assigned programs, providing ongoing oversight throughout trial execution, including review of emerging data, identification of scientific risks, and interpretation of results.
• Partner closely with clinical operations to ensure Phase 3 trials are scientifically sound, operationally feasible, and executed in accordance with protocol, timelines, and quality standards.
• Collaborate with biostatistics and data management to support statistical analysis plans, data review activities, interim analyses (as applicable), and final interpretation of clinical outcomes.
• Contribute to and support regulatory interactions, including preparation of briefing documents, responses to information requests, and participation in meetings with health authorities as a scientific representative of the program.
• Lead or significantly contribute to the preparation of clinical study reports, integrated summaries, investigator brochures, external presentations, scientific content for regulatory submissions, publications, author responses to questions from health authorities and other stakeholders.
• Support safety monitoring activities, including review and interpretation of adverse events and safety data, participation in safety review meetings, and collaboration with pharmacovigilance to ensure appropriate benefit–risk assessment for late-stage programs.
• Provide scientific input into investigator meetings, site feasibility and selection activities, and key study communications to ensure consistency and clarity across global trial sites.
• Mentor junior clinical scientists and contribute to the development of best practices, processes, and standards appropriate for a Phase 3–stage organization.

Deliver on other related projects and initiatives as assigned, with flexibility to support evolving program needs in a growing biotechnology environment.

Qualifications:

• Education and Certification
  • Master’s or Ph.D. in a relevant scientific discipline required
• Work Experience
  • 6–10+ years of experience in pharmaceutical or biotechnology clinical development setting, experience in Ophthalmology a plus
  • Demonstrated experience supporting or leading Phase 3 clinical trials, including protocol development, data interpretation, and clinical study reporting
  • Prior experience in rare disease and/or ophthalmology drug development strongly preferred
  • Experience supporting regulatory interactions and late-stage clinical submissions (e.g., NDA/BLA/MAA components) highly desirable
  • Experience working in a cross-functional, matrixed environment typical of small to mid-sized biotech companies
• Skills and Key Success Factors:
  • Deep understanding of late-stage clinical development and the scientific and regulatory expectations for pivotal trials
  • Strong scientific judgment with the ability to independently assess data, identify risks, and propose solutions
  • Entrepreneurial mindset with comfort operating in a fast-paced, resource-conscious organization
  • Highly organized and detail-oriented, with a strong commitment to data quality, accuracy, and compliance
  • Excellent written and verbal communication skills, including the ability to clearly convey complex clinical data to internal and external stakeholders
  • Collaborative leadership style with proven ability to influence across disciplines without direct authority
  • Hands-on, proactive approach with a strong sense of accountability and urgency
  • Highest standards of professionalism, integrity, and ethical conduct

Other Relevant Information:

• Travel: Able to travel as assigned

Compensation

• Base Salary Range: $160K - $240K, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
• Discretionary Bonus: 15% - 20% of Base Salary, contingent upon meeting performance components
• Equity: initial grant of incentive stock options
• Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.

The Opportunity

We are seeking a Senior Director, Market Access Strategy to support a new product launch. This leader will own the creation of the payer value proposition, lead pricing strategy for launch, and prepare effective communications across payer, distribution channel, field access, and patient support teams.

As a key member of the Market Access leadership team, you will work cross functionally to drive strategies for all market access functions, oversee a post-launch marketing and pricing operations team, and effectively manage any vendors that support these initiatives.

Responsibilities

• Shape and lead the payer value story for Amylyx’s first launch product, translating clinical, economic, and real‑world evidence into a differentiated, evidence‑based value proposition that supports optimal access and reimbursement.
• Drive payer marketing and launch execution in close partnership with Medical Affairs, including development of PIE content, AMCP dossiers, and comprehensive launch education materials.
• Partner with Medical and Access leadership to define payer evidence requirements, identify data gaps, and execute strategies to address unmet needs across pre‑ and post‑launch phases.
• Develop and deploy access tools and communications that enable field access teams, patient support programs, and pharmacy partners to execute effectively and consistently.
• Establish a cross‑functional performance feedback loop across payer, field access, pharmacy, and services teams to rapidly identify access barriers and drive issue resolution.
• Build and oversee post‑launch pricing operations, including list price governance, price change management, pricing committee leadership, and close collaboration with Finance on gross‑to‑net management.
• Lead agencies and vendors, monitor payer and policy dynamics, and represent market access strategies including performance, risks, and opportunities—to internal stakeholders and senior leadership.

Required Qualifications

• Bachelor’s degree required
• 12+ years of experience in pharmaceutical market access, pricing, reimbursement strategy, and payer marketing
• Prior launch experience in US market
• Deep expertise in the U.S. payer, reimbursement, coverage, and coding landscape for specialty products under the pharmacy benefit
• Proven experience developing payer value propositions and payer‑facing materials
• Strong analytical skills using market access data sources (e.g., HUB, specialty pharmacy, and claims data)
• People leadership experience, including hiring, coaching, and developing teams
• Demonstrated experience with pricing strategy, contract modeling, and gross‑to‑net management
• Strong vendor management and contracting experience across agencies, consultants, analytics partners, and pricing operations vendors

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

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

Location: Cambridge, MA, USA, Full-time

Company Description

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

About the Job

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

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

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

Roles and Responsibilities

Strategic Leadership & Planning

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

Scientific Communications & Content Development

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

Omnichannel Execution

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

Cross-Functional Collaboration & Stakeholder Engagement

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

Training & Internal Enablement

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

Governance, Compliance & Operations

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

Qualifications & Experience

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

The Role:

Reporting to the Vice President, Information Technology, the Director, IT Business Partner, GXP will serve as a strategic technology leader responsible for aligning IT capabilities with business objectives across all GXP-regulated departments (GMP, GLP, GCP) as the organization prepares for commercial launch. This role requires deep expertise in pharmaceutical IT systems, regulatory compliance, and the ability to translate complex business requirements into scalable technology solutions that support quality, compliance, and operational excellence.

Responsibilities:

• Partner with GXP business leaders to understand strategic objectives and translate them into comprehensive IT roadmaps that support launch readiness and sustainable operations
• Oversee selection, implementation, and validation of critical GXP systems
• Ensure all IT systems comply with FDA 21 CFR Part 11, EU Annex 11, and data integrity requirements (ALCOA+)
• Lead Computer System Validation (CSV) activities and maintain audit readiness
• Drive IT readiness for commercial launch including system scalability, disaster recovery, and capacity planning
• Build and lead team of IT professionals focused on GXP systems; manage vendor relationships
• Partner with Quality and Regulatory Affairs to support inspections and maintain compliance
• Lead project lifecycle activities such as planning, requirement gathering, design, build, testing, implementation and post-implementation support of GxP applications and related business processes.
• Develop enterprise architecture

Competencies:

• Deep understanding of GXP regulations and their application to IT systems
• Strong knowledge of pharmaceutical manufacturing, quality, and clinical operations
• Experience with GAMP 5, industry standards, and cloud technologies in regulated environments
• Exceptional stakeholder management and communication skills across all organizational levels
• Strategic thinker with strong business acumen and ability to deliver complex projects on time and budget
• Experience in leveraging Enterprise Architecture to deliver business value

 Qualifications:

• Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or related field required
• 10+ years of progressive IT experience in pharmaceutical, biotechnology, or regulated healthcare manufacturing environments
• 5+ years in a leadership role managing IT business partnerships, systems implementations, or GXP IT operations
• Demonstrated experience supporting commercial launch activities or significant operational scale-up in a pharmaceutical setting
• Proven track record implementing and managing multiple GXP-regulated systems, especially Veeva systems
• Hands-on experience with Computer System Validation (CSV) and regulatory compliance requirements (21 CFR Part 11, EU Annex 11, data integrity)
• Experience managing IT budgets, vendor relationships, and cross-functional projects
• PMP, ITIL, or relevant IT certifications
• Knowledge of serialization, track-and-trace, and emerging technologies (AI/ML, analytics)

 Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Opportunity

Amylyx is seeking a Senior Medical Director, Clinical Development to provide strategic and scientific leadership for one or more late-stage, pivotal programs with the potential to expand into additional indications and/or programs within the same molecule or across the portfolio. This individual will play a critical role in shaping the overall clinical development strategy and may lead multiple programs or key components of a broader development portfolio.

Reporting to the Senior VP of Clinical Development, you will be responsible for leading the design, execution, and interpretation of clinical studies and overseeing the development and implementation of Clinical Development Plans across assigned assets. You will provide strategic input into study design, endpoints, and regulatory strategy, ensuring alignment with the overall program and corporate objectives.

The successful candidate will collaborate with cross-functional teams in a matrix environment, influencing stakeholders across Research, Regulatory Affairs, Clinical Operations, and Commercial to ensure that clinical and scientific considerations are fully integrated into development plans. You will proactively identify and mitigate risks, guide decision-making through data-driven insights, and ensure the highest standards of scientific rigor and data integrity.

In this role, you will also serve as a key external representative, engaging with global medical experts, investigators, regulatory authorities, and alliance partners. You may lead or mentor a team of clinical scientists and physicians and contribute to broader organizational and portfolio-level initiatives.

Responsibilities

• Provides strategic medical leadership and oversight for assigned clinical programs, including late-stage and pivotal trials.
• Leads development and execution of Clinical Development Plans (CDPs), integrating clinical, scientific, regulatory, and commercial considerations.
• Drives study design, protocol development, and interpretation of complex clinical data to inform key program decisions.
• Serves as a core member of cross-functional program teams, influencing strategy and ensuring alignment across disciplines.
• Provides senior-level medical monitoring and guidance, ensuring patient safety, data integrity, and high-quality trial execution.
• Leads interactions with external stakeholders including key opinion leaders, investigators, regulatory agencies, and alliance partners.
• Oversees preparation of key program documents including protocols, investigator brochures, clinical study reports, regulatory submissions, and publications.
• Mentors and provides scientific guidance to junior team members, including Medical Directors and Clinical Scientists.
• Identifies and implements process improvements and best practices within Clinical Development.

Required Qualifications

• MD required
• Significant experience in late-stage clinical development and drug development in biotech/pharmaceutical industry; rare disease experience strongly preferred
• Typically 5+ years of experience leading clinical development programs with demonstrated impact on program strategy and execution
• Demonstrated ability to collaborate with cross-functional teams and influence without authority in a matrix environment
• Strong strategic thinking, problem-solving, and decision-making skills
• Proven ability to interpret complex clinical data and translate insights into actionable strategies
• Excellent communication and leadership skills, with experience interacting with senior stakeholders and external experts
• Experience mentoring or leading team members preferred
• Ability to travel internationally and domestically

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

The Role:

Reporting to the Senior Director, Payer & Reimbursement, the Director, Market Access Marketing plays an essential role executing the Market Access strategy, including Payer, Pricing and Patient Support Services strategies, to ensure our upcoming product launches in ROS1 NSCLC and ALK+ NSCLC are strategically positioned to achieve payer coverage, organized customer access, and patient access. This role will be responsible for payer marketing, organized customer marketing, patient support services marketing, and creating market access initiatives to optimize coverage, adoption, and reimbursement of our novel therapies. Given the cross-functional nature of the role, the market access marketer will have a dotted reporting line to the Vice President, Marketing. S/he will also collaborate closely with Sales, HEOR, and Medical Affairs to drive launch readiness and post-launch success.

Responsibilities:

Strategic Planning

• Payer & Health Care Decision Maker (HCDM) Messaging Strategy – Develop compelling value propositions and messaging highlighting clinical benefits, cost-effectiveness and differentiation.
• Agency Management – Manage market access marketing AOR to refine and implement strategy, messaging, and materials.
• Work with cross-functional teams to inform and execute pricing, reimbursement and access strategies aligned with business objectives.
• Identify and capitalize on strategic opportunities to best position Nuvalent products at National Accounts (e.g., GPOs, Physician Networks, National and Regional Payers, Pathways and Strategic Partners), including overseeing the execution of marketing tactics at annual meetings

 Market Access & Payer Engagement Support

• Develop Market Access Materials – Create tailored account director presentations, digital content and key messaging to deliver to payer and provider HCDMs.
• Pre-Approval Information Exchange (PIE) – Refine and implement PIE strategy, messaging and materials to effectively meet payer expectations and regulatory guidelines.
• Value Proposition – Craft evidence-based messaging to support differentiation story, formulary inclusion, pathway placement, and EHR integration.
• FAQs & Reimbursement Guide – Prepare pricing, coding and coverage documents addressing payer concerns.
• Distribution Selling Sheets – Equip distribution partners with materials on product availability and logistics.

 Integrated Delivery Network, GPO Engagement, & Patient Services Support

• Access Materials for GPO and IDN HCDMs – Educate healthcare professionals on reimbursement and formulary details.
• Patient Support Programs – Develop resources for PSP including patient services website, financial assistance and copay support.
• Patient Access Content and Materials – Ensure patients have clear coverage, affordability, and access guidance.

 Internal Training & Strategic Insights

• Training Materials for Market Access Account Director teams – Create and execute training plans for teams to effectively utilize market access marketing materials
• Training Materials for Sales – Provide customized formulary status updates, access and reimbursement guides for sales team
• External Access Communications – Updating external stakeholders on formulary status and changes
• Stakeholder Insights – Organize Payer & Provider Advisory Boards for market insights.
• Competitive & HEOR Analysis – Incorporate relevant HEOR into value messaging and monitor pricing, access strategies and cost-effectiveness data to incorporate.
• Regulatory & Compliance Oversight – Ensure all materials meet FDA, CMS, and payer regulations.

 Competencies Include:

• Entrepreneurial mindset, and a successful track record working in a fast-paced, rapid-growth environment.
• Proven ability to manage multiple projects, identify and address needs, build internal capabilities and deliver results.
• Excellent interpersonal skills, with the ability to gain alignment by working collaboratively and inclusively across corporate functions.
• Strong verbal and written communication skills.
• Strong analytical skills and ability to translate data into actionable insights.
• Record of achievement, innovation, and compliance.

Qualifications:

• Bachelor’s degree required; advanced degree (MBA, PharmD, or PhD) preferred.
• 10+ years of experience in biotechnology, pharmaceuticals, or healthcare with a focus on market access marketing, or payer/organized customer/reimbursement strategy.
• Experience developing market access marketing strategies and executing tactics
• Product launch experience, preferably including oral oncology therapies
• Experience collaborating with external stakeholders to gather and incorporate insights.
• Deep understanding of payer and reimbursement landscape, including Medicare, Medicaid, and Commercial insurers.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

The Senior Director, Clinical Pharmacology will lead Nuvalent’s clinical pharmacology strategy across all development programs, including late‑stage registrational efforts and emerging early‑phase assets. This leader will guide dose optimization, exposure–response modeling, regulatory strategy, and clinical pharmacology components of NDA submissions.  

Responsibilities:

• Serve as the clinical pharmacology lead and develop and execute strategies to support Phase 1, registrational, and post‑marketing studies, including designing and leading clinical pharmacology studies.
• Drive the integration of PK, PD, safety, and efficacy data to inform dose selection, dose modification, and labeling recommendations.
• Lead clinical pharmacology contributions to INDs, CTAs, IBs, and NDA submissions.
• Represent clinical pharmacology in interactions with FDA and other global regulators, supporting discussions related to dose justification, pediatric waivers, safety margins, and DDI strategies.
• Partner closely with DMPK, Non-clinical Toxicology, Clinical Development, Biostatistics, CMC, and Regulatory Affairs to ensure cohesive end‑to‑end development plans.
• Oversee population PK modeling, PK/PD modeling, and exposure–response analyses for efficacy and safety.
• Guide quantitative pharmacology approaches supporting optimal dosing in patients.
• Build and mentor a growing clinical pharmacology function as Nuvalent transitions from clinical‑stage to commercial‑
• Contribute to portfolio prioritization, scenario planning, and long‑range clinical development strategy.

 Competencies:

• Demonstrated ability to collaborate across matrixed, cross-functional teams in a fast-paced environment.
• Proven ability to manage multiple projects simultaneously with attention to timelines and detail.
• Strong communication and interpersonal skills; build trust and foster relationships internally and externally.
• Able to work independently, take initiative, and adapt quickly to evolving priorities.
• Recognized leader who exhibits effective communication, emotional intelligence, and influencing skills, within a matrix operating environment.
• Demonstration of strategic thinking and high-level planning while also balancing the ability to manage and execute operational details.
• Ability to effectively manage multiple projects with competing priorities.

  Qualifications:

• D., Pharm.D., or M.D. with specialization in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related discipline.
• 12+ years of experience in clinical pharmacology within biopharma, including leadership in oncology or small‑molecule drug development.
• Proven track record supporting registrational‑stage programs and authoring components of regulatory submissions (INDs, NDAs/MAAs).
• Prior work with kinase inhibitors, and oncology therapies strongly preferred.
• Familiarity with late‑phase trial design and commercial launch preparation.

 Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more

We are seeking a people focused and accomplished leader to join our team as Vice President, Clinical Operations to lead and expand the company’s clinical operations capabilities supporting clinical programs in retinal diseases.  

Position Summary 

The Vice President, Clinical Operations role is a key leadership position responsible for the strategic planning, execution, and oversight of global clinical trials, with particular focus on Phase 3 and other late-stage studies. 

This individual plays a critical role in ensuring operational excellence across the clinical development portfolio, including the successful delivery of pivotal clinical trials supporting global regulatory filings. The Vice President will lead and mentor a clinical operations team, collaborate cross-functionally across the R&D organization, and oversee external partners to ensure clinical studies are executed efficiently, ethically, and in full compliance with regulatory standards and Good Clinical Practice (GCP). 

As a senior leader in R&D, this individual contributes to clinical development strategy and cross-functional planning while representing Clinical Operations internally with leadership and externally with investigators, CRO partners, and other clinical stakeholders. 

Primary Responsibilities 

• Develop clinical operations strategies and implementation plans, in partnership with internal and external stakeholders, to support the company’s clinical development goals. 

• Lead the planning, initiation, and execution of global clinical trials across multiple programs, with particular focus on Phase 3 and other pivotal studies. 

• Build and lead a high performing clinical operations organization, mentoring team members and fostering a collaborative and accountable culture. 

• Lead relationships with external partners including CROs, central laboratories, and other vendors, ensuring effective vendor selection, governance, and performance management. 

• Ensure the successful operational execution of clinical studies in accordance with study protocols, timelines, budgets, and regulatory requirements. 

• Collaborate closely with Clinical Development leadership to translate clinical strategy into operationally feasible study designs and execution plans. 

• Participate in cross-functional teams for assigned programs, partnering with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Safety, and Medical Affairs to achieve high-quality study execution. 

• Ensure compliance with global regulatory standards and guidelines governing clinical trials, including Good Clinical Practice (GCP). 

• Provide operational input into clinical study protocols, feasibility assessments, site selection strategies, and patient recruitment and retention plans. 

• Oversee clinical trial budgets and resource planning, ensuring efficient utilization of resources and alignment with company priorities. 

• Identify operational risks and implement mitigation strategies to ensure timely trial execution and data quality. 

• Support regulatory submissions and inspections by ensuring operational documentation and trial conduct meet regulatory expectations. 

• Present clinical operations strategies, study progress, and operational updates to senior leadership and other stakeholders. 

• Deliver on other related projects as assigned. 

Qualifications 

• Education and Certification:  

• Bachelor's degree in a scientific or healthcare related field; advance degree preferred. 

• Work Experience 

• 12+ years of experience in clinical research and clinical operations within the pharmaceutical or biotechnology industry. 

• Demonstrated leadership in global clinical trial execution, including operational oversight of Phase 3 or other pivotal trials. 

• Proven track record of leading clinical operations teams and managing complex global clinical programs. 

• Extensive experience managing CRO partnerships and other external vendors supporting clinical trials. 

• Strong knowledge of global regulatory requirements governing clinical trials, including Good Clinical Practice (GCP). 

• Experience supporting regulatory submissions and inspections related to clinical trials. 

• Experience contributing to clinical development plans and cross-functional program strategy. 

• Experience in rare disease and/or ophthalmology drug development preferred.  

• Ability to adapt to changing circumstances and industry trends. 

• Significant experience in leading and managing clinical operations teams. 

• Skills and Key Success Factors:
  • Entrepreneurship spirit with a passion to build, learn and evolve with the team
  • Highly organized and detail oriented with a passion to deliver quality results
  • Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
  • Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
  • Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
  • Evidence of "hands-on" experience and expertise
  • Proven and successful track record as a team-player and collaborator in small working environments
  • Highest levels of professionalism, confidence, personal values and ethical standards

Other Relevant Information:

• Travel: able to travel up to 35% of time 

Compensation

• Base Salary Range: $300K - $320K, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
• Discretionary Bonus: up to 30% of Base Salary, contingent upon meeting performance components
• Equity: initial grant of incentive stock options
• Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.

The Opportunity:

As a Senior / Medical Director at Relay Tx, you will help advance our clinical pipeline from IND to proof of concept to registration.  Specifically, you will collaborate with senior medical staff to drive clinical strategy, clinical trial design, and execution.  Working cross-functionally with clinical project management, regulatory affairs, clinical operations, biostatistics, data management and medical writing, you will play a key role as Relay Tx continues to introduce product candidates into the clinic.  You will provide clinical leadership to R&D teams and will work closely with Development leadership.   

We are open to remote employees

About You:  

• Collaborate with senior medical staff, drug discovery teams, translational oncology, clinical operations, clinical investigators and disease-specific experts to design and execute early clinical development plans that definitively test key translational hypotheses for Relay Tx medicines and establish clinical proof-of-concept as soon as possible after entering human testing. 

• Write clinical sections of key documents, including Investigator’s Brochures, IND summary documents, CTAs for initiation of ex-US studies and work with senior medical staff for responses to questions from regulatory authorities, IRBs, and ethics committees. 

• Provide expert medical review, assessment, and interpretation of clinical data and prepare results for presentation to internal clinical development leadership and external stakeholder including regulatory authorities.  

• Manage drug safety and pharmacovigilance activities for ongoing trial(s). 

• Attend and support clinical site initiation visits. 

• Rapidly integrate new insights derived from on-going Relay Tx or external clinical trials, translational science or basic science into Relay Tx development plans and clinical trial activities. 

• Collaborate with research leadership and drug discovery teams to shape the Relay Tx drug discovery portfolio. 

• Proactively manage communication and build strong collaborative relationships with key stakeholders.

• Ensure Relay Tx maintains the highest standards of compliance and ethical behavior in the design, conduct, interpretation and communication of clinical trials, clinical trial data, and clinical trial results. 

Your Background:  

• Experience working with solid tumors.
• A dynamic team player and effective communicator that thrives in a fast-paced environment. 
• MD, MD/PhD or other advanced degree with 5+ years of clinical development experience in academic and/or industry settings with work in oncology.  Motivated candidates with lesser experience and a passion to learn precision oncology clinical development and contribute to cross functional development teams will also be considered.
• Exposure to design and execution of clinical trials; protocol development and design, development of case report forms, and statistical analysis plans. 
• Exposure to working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel involved in clinical trials. 
• Excellent written and oral communication skills. 
• The successful applicant will thrive in the Relay Tx corporate culture where the core values are relentless, fearless, craftsmanship, candor, and humanity. You will be a key contributor to Relay clinical development and enabled to make a significant positive impact for patients. 

Estimated Salary Range: [$213,000 - $350,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

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