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?

We are seeking an experienced leader in vivarium and in vivo operations to oversee our research animal facilities and in vivo study support. In this Associate Director role, you will be accountable for daily operations, resource planning, budgets, technical training and compliance with IACUC, AAALAC and institutional policies. 

You will manage animal procurement, housing, husbandry services and technicalsupport across discovery and pre‑clinicalstudies, collaborating with program leaders and CRO partnersto align operationalsupport with scientific objectives. A key aspect of this role is developing and coaching a high‑performing technical team while driving operational excellence and continuous improvement to uphold the highest standards of animal welfare.

Key abilities of this role include:

• Provide strategic and operational leadership for vivarium operations, ensuring high-quality husbandry, facility maintenance, and resource planning.
• Serve as institutional lead for IACUC protocols and animal use compliance; prepare and lead facility audits and inspections.
• Oversee procurement and inventory of animals and supplies and maintain accurate records of census and environmental conditions.
• Develop and manage the vivarium operating budget, forecasting resource needs and supporting capital planning. 
• Provide oversight and coordination of in vivo hands on training and SOP adherence for a cross functional group of hybrid scientists; remain willing to perform hands on work as needed and lead the integration of new skills and techniques as our portfolio and programs expand. 
• Coordinate study scheduling and operational support across in vivo pharmacology programs and CRO partners; represent in vivo operations in cross-functional meetings.
• Drive process improvement, SOP development and emergency preparedness; ensure compliance with AAALAC and institutional policies.
• Provide subject matter expertise in in vivo study execution, facility operations, and support program teams by troubleshooting logistics.

What you’ll need to be successful:

• Bachelor’s or master’s degree in biological sciences, animal science or related discipline; 10+ years of vivarium/in vivo experience including 5+ years in a leadership role; advanced degree (M.S., DVM or Ph.D.) and AALAS/CMAR certification are preferred.
• Demonstrated success managing vivarium operations, including budgets, resource forecasting, animal procurement and facility maintenance.
• In depth knowledge of AAALAC and IACUC regulations and experience serving as institutional lead for animal use protocols and facility audits.
• Proven ability to supervise, mentor, and develop technical staff and maintain high standards of animal welfare and safety.
• Strong operational planning, problem-solving and process improvement skills, with experience developing SOPs and emergency plans. 
• Excellent communication and interpersonal skills and ability to collaborate across cross functional program teams and with CRO partners.
• Ability to thrive in a fast paced, collaborative environment, work on site and participate in weekend or holiday coverage as needed.

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 $165,000-$200,000, 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

The Role:

Reporting to the Senior Director of Pharmacovigilance (PV) Operations, the Associate Director, PV Operations will provide vendor oversight and review of ICSR processing for assigned investigational products. They will ensure compliance and adherence to Safety processes and SOPs as well as manage and analyze data from the Global Safety Database. This SME will be responsible for PV operations’ role in Phase 1, 2, & 3 clinical studies, inclusive of inspection readiness, reconciliation, SMP maintenance, and site and regulatory authority reporting oversight. They will work in close collaboration with PV physicians and PV scientists on operational safety and case quality issues.

Responsibilities:

• Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities.
• Provide Sponsor oversight of operational safety responsibilities, including the timely and accurate execution of the processes defined within the applicable Safety Management plans.
• Participate in daily management, operational oversight and execution of operational safety tasks for assigned Nuvalent clinical programs.
• Review incoming adverse event reports and communications from vendors to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports.
• Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent Pharmacovigilance team.
• Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams within Nuvalent, and clinical vendors, as required) and facilitate case closure within required timelines.
• Serve as PV operations SME on safety reporting processes according to study protocol.
• Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices.
• Serve as resource and contact for other functions within the company for pharmacovigilance
• operational activities.
• Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation
•  
• Responsible for the development of safety management plans for assigned programs, and associated documents to ensure that study-specific and Regulatory Authority reporting requirements are met and that workflow responsibilities between CROs, and Nuvalent are clearly delineated and adhered to

Competencies Include:

• Excellent written and verbal communication skills.
• Demonstrated communications expertise with the ability to articulate, influence, and work successfully with internal/external stakeholders and within a matrixed environment.
• Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
• Demonstrated contribution to strategy and innovation. Contributes to or leads actionable strategies.
• Demonstrated project management and prioritization capabilities.

Qualifications:

• Bachelor’s degree in Nursing, RN, Pharmacy, Pharm D., or other relevant health-care related fields.
• 8-10 years of progressive drug safety experience in a biotech/pharma company.
• Clinical Development experience.
• Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS
• Ability to interpret and follow regulatory guidelines.
• Proven knowledge of Good Documentation Practices and cGXPs.
• Basic knowledge of MedDRA coding.
• Experience in ICSR case-processing and reporting.
• Experience working in and with safety databases.
• Direct experience managing relationships with service providers or external business partners

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.

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.

Company Summary: 

Prologue Medicines uses advances in structural predictions and large language models to functionally annotate the entire viral proteome to leverage millennia of viral evolution for the development of transformative medicines. Prologue has nominated two development candidates and is building a broad pipeline of therapeutics across several therapeutic areas. One of Prologue Medicines’ founding principles is to build an inclusive and exciting working environment that fosters personal and professional growth by ensuring that all team members contribute to and feel ownership of our scientific vision. 

Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $90 billion in aggregate value. 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 twice named to Fast Company’s annual list of the World’s Most Innovative Companies. Learn more about Flagship at www.flagshippioneering.com. 

Position Summary: 

We are seeking an exceptional scientific leader to serve as VP/SVP, Biology & Translational Science, responsible for driving our discovery and early development strategy from target identification through IND and continue to support the program as needed through clinical development. This individual will integrate deep expertise in immunology, translational science and/or protein biologics to build a high-impact pipeline and ensure successful progression of programs into the clinic. The ideal candidate will have a proven ability to develop effective strategies and execution plans to advance early molecules through preclinical development to ensure emerging assets exhibit strong differentiation and possibility of success. They should have an excellent understanding of the landscape of immune-mediated diseases to help build a diversified pipeline.. The successful candidate will be an enthusiastic, goal-driven individual who participates as a strategic leader while fostering a culture of executional excellence.   

Key Responsibilities: 

Translational Science & Clinical Readiness 

• Define translational strategies to bridge preclinical findings to human studies
• Lead identification and implementation of biomarkers (PD, predictive, and safety)
• Ensure programs are designed with clinical endpoints and patient stratification in mind
• Increase probability of clinical success through mechanism-based approaches.
• In collaboration with PKPD/ QSP modeling team, develop translational frameworks for AI enabled derisking of drug development path 

Biologics Development (Hit ID to IND) 

• Lead progression of protein biologics programs from hit identification through lead optimization and IND-enabling studies
• Partner cross-functionally with discovery and development teams to build out and drive comprehensive IND strategy, including pharmacology, safety, and translational packages
• Ensure clear go/no-go decision frameworks across discovery and preclinical stages
• Proactively recognize and develop creative solutions for emerging technical and scientific issues 

Discovery Biology & Target Strategy 

• Lead target identification, evaluation, and nomination grounded in human biology and disease relevance
• Define and drive biological hypotheses aligned with company strategy, with a focus on immunology
• Oversee development of robust in vitro and in vivo models to validate targets and mechanisms
• Build and prioritize a portfolio strategy for multiple differentiated biologics programs 

Leadership & Cross-Functional Integration 

• Build, mentor and lead high-performing teams delivering across biology, pharmacology, and translational science. Identify, initiate, and manage productive collaborations with CROs, partners and academic labs as appropriate to driving projects forward and collaborate closely with clinical development, regulatory, and executive leadership
• Develop, motivate and inspire a high-performing Biology and Translational Science organization
• Serve as an enterprise leader, driving cross-functional alignment, clear decision-making, and a culture of accountability, innovation, and executional excellence.
• Serve as a key scientific voice with board members, investors, and external partners
• Foster a culture of rigor, innovation, collaborative and decisive execution 

Qualifications: 

• PhD or MD/PhD in pharmacology or biological disciplines such as immunology, cellular biology, oncology, or biochemistry, with 10+ years direct pharmaceutical experience beyond postdoctoral work 
• Deep expertise in immunology with a strong understanding of disease biology
• Proven track record advancing protein biologics from hit identification to IND
• Significant experience in target selection and nomination
• Demonstrated ability to lead cross-functional teams to drive go/no go decisions
• Excellent project management skills and the ability to effectively manage CROs and to facilitate interactions with academic labs and companies to ensure project progression.
• Demonstrated success in translational science, including biomarker strategy and IND-enabling work and direct experience in supporting IND strategy and documentation, including writing relevant pharmacology sections of INDs.
• Flexibility to dynamical adapt workplans and lead teams through changing priorities and deadlines.
• A pioneering mindset to grow a startup venture
• Prior experience working in smaller companies is highly preferred 

Leadership Profile 

• Strategic thinker with strong scientific judgment
• Ability to make high-quality decisions under uncertainty
• Skilled at balancing innovation with execution discipline
• Effective communicator with strong external presence
• Passion for building teams and developing talent 

Impact 

This role will shape the company’s scientific direction and pipeline, directly influencing the success of programs entering the clinic and ultimately improving patient outcomes. 

Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. 

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 $275,000 - $340,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Prologue Medicines, Inc. currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Prologue Medicines, Inc.'s good faith estimate as of the date of publication and may be modified in the future.

The Role:

Reporting to the Senior Director of Pharmacovigilance (PV) Operations, the Associate Director of PV Operations will provide vendor oversight and review of ICSR processing. They will ensure compliance and adherence to Safety processes and SOPs as well as manage and analyze data from the Global Safety Database. This SME will be the primary point of contact for quality oversight of the case processing vendor. They will work in close collaboration with PV physicians, PV scientists, and PV Excellence on operational safety and case quality issues The role will expand and evolve in line with Nuvalent’s expansion as we approach potential market authorization.

Responsibilities:

• Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities.
• Provide Sponsor oversight of operational safety responsibilities, including the timely and accurate execution of the processes defined within the applicable Safety Management plans.
• Monitor performance (metrics, other reports) of the safety vendor and the quality output of the ICSRs; provide appropriate feedback and training.
• Monitor key performance indicators of case processing and present findings to Head of PV and cross-functional stakeholders.
• Participate in daily management, operational oversight and execution of operational safety tasks for assigned Nuvalent clinical programs.
• As needed. review incoming adverse event reports and communications from vendors to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports.
• Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent Pharmacovigilance team.
• Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams within Nuvalent, and clinical vendors, as required) and facilitate case closure within required timelines.
• Serve as PV operations SME on safety reporting processes according to study protocol.
• Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices.
• Serve as resource and contact for other functions within the company for pharmacovigilance
• operational activities.
• Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation.

Competencies Include:

• Excellent written and verbal communication skills.
• Demonstrated communications expertise with the ability to articulate, influence, and work successfully with internal/external stakeholders and within a matrixed environment.
• Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
• Demonstrated contribution to strategy and innovation. Contributes to or leads actionable strategies.
• Demonstrated project management and prioritization capabilities.

Qualifications:

• Bachelor’s degree in nursing, RN, Pharmacy, Pharm D., or other relevant health-care related field.
• 8-10 years of experience in a biotech/pharma company.
• Direct experience managing relationships with service providers or external business partners
• Clinical Development experience.
• Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS
• Ability to interpret and follow regulatory guidelines.
• Proven knowledge of Good Documentation Practices and cGXPs.
• Basic knowledge of MedDRA coding.
• Experience in ICSR case-processing and reporting.
• Experience working in and with safety databases.

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.

Position Overview

We are seeking an enthusiastic, self-motivated Senior Scientist to join the Nonclinical Development group, supporting the nonclinical safety assessment function for IND-enabling programs across Prime Medicine’s pipeline. Reporting to the Associate Director, Safety Assessment, the successful candidate will support the design, execution, and interpretation of nonclinical safety studies conducted both in-house and at CROs, with an initial focus on liver-targeted therapeutics. This role requires hands-on involvement in assay execution and troubleshooting, as well as active participation in study oversight of work being done at CRO and data analysis.

This role requires collaboration within cross-functional teams. The ideal candidate will hold a Ph.D. in toxicology or a related field with 6+ years of pharma/biotech experience in nonclinical safety assessment, or an M.S. in toxicology or a related field with 10+ years of experience in nonclinical safety assessment, the ability to work independently, provide domain expertise and leadership, as well as cross-functionally in a fast-paced, matrixed environment with a positive, flexible attitude.   

Primary Responsibilities

• Contribute to nonclinical safety activities as part of cross-functional Discovery and Development project teams, supporting program progression through IND-enabling stages.
• Design, execute, and troubleshoot nonclinical safety studies, including hands-on laboratory work (~30%) to support assay development, data generation, and issue resolution.
• Support the execution and oversight of nonclinical safety studies (GLP and non-GLP) at CROs, including active involvement in troubleshooting assay and study-related challenges.
• Analyze and interpret study data with guidance and contribute to the preparation of study reports and supporting documents for regulatory submissions.
• Collaborate with Pharmacology, DMPK, and other functions to support exploratory studies (e.g., exploratory toxicology, DMPK, biodistribution, and delivery platform evaluation).
• Contribute to evaluation of new delivery approaches, Lipid and RNA components, and emerging targets to support pipeline expansion.
• Assist in identifying potential safety findings and contribute to discussions on data interpretation and next steps.
• Ensure studies and internal activities are conducted in compliance with regulatory guidelines and internal standards.

Preferred Qualifications

• Ph.D. in toxicology or a related discipline with 6+ years of biopharmaceutical industry experience, or M.S. in toxicology or a related field with 10+ years of relevant biopharmaceutical industry experience supporting drug development in nonclinical safety/toxicology.
• Experience in large molecule therapeutic development, along with a background in immunology, is desirable.
• Understanding of toxicology principles, nonclinical safety evaluation, and the drug development process, with some experience interpreting toxicology data and contributing to technical and scientific reports.
• Demonstrates strong scientific judgment and leadership with the ability to evaluate information, identify potential issues, and propose practical solutions with guidance as needed.
• Highly organized and detail-oriented with strong attention to accuracy and quality.
• Strong communication and collaboration skills, with the ability to work effectively across multidisciplinary teams and with external partners.
• Experience supporting nonclinical studies at CROs is preferred but not required.

Your Impact at LILA

Lila is seeking a talented and experienced Technical Science Writer / (Content Creator) to help shape how we explain our work to the world. This role is akin to a managing editor: you will translate complex scientific and technical work into rigorous, accessible content, and you will guide a small bench of contractor writers to deliver consistently high-quality storytelling.

This is a mission-critical role because great science only changes the world when it is understood and trusted. Your work will help:

• Customers understand what Lila enables, how it works, and why it is reliable.
• Partners see where collaboration creates leverage and what “good” integration looks like.
• Government and public-sector partners assess relevance, safety, and societal value.
• Investors understand the technical moat, the platform strategy, and the long-term trajectory.
• Future employees understand the ambition, the rigor, and the problems they will help solve.

What You'll Be Building

• Write and edit high-quality articles, explainers, technical overviews, case studies, and multimedia scripts that communicate complex scientific topics with accuracy and narrative strength.
• Build content that connects what we are building to why it matters, with an emphasis on scientific integrity, measurable impact, and responsible communication.

Audience-specific storytelling

• Adapt messaging and format for distinct stakeholder needs:
  • Customers: practical outcomes, workflows, reliability, and real constraints.
  • Partners: shared roadmaps, joint innovation stories, and integration narratives.
  • Government partners: public benefit, validation, safety, and responsible use.
  • Investors: differentiation, defensibility, and platform trajectory.
  • Candidates: mission, culture of rigor, and the kinds of problems they will own.
• Create “layered” assets where a single core story can be repurposed into multiple depths (social post → blog → technical brief → talk track).

Editorial leadership and managing editor responsibilities

• Assign projects to contractor writers, set clear briefs, and provide feedback to ensure quality, coherence, and consistent voice.
• Establish lightweight editorial workflows (intake, review, fact-check, approvals) that keep content moving without compromising accuracy or confidentiality.

Research and collaboration

• Partner closely with scientists, engineers, and leaders to gather insights, pressure-test claims, and capture the “why” behind the work.
• Translate internal notes, talks, and research milestones into externally appropriate narratives.

Visuals and multimedia

• Oversee development of visuals (figures, diagrams, infographics), photography, and short-form video concepts that enhance comprehension.
• Work with design/creative partners to keep visuals consistent with Lila’s standards while making science legible and engaging.

Quality and trust

• Own editorial quality: accuracy, coherence, and clear sourcing. Maintain journalistic standards (including Associated Press style where applicable).
• Ensure content reflects responsible communication: no hype, no overclaims, and clear framing of what is validated vs. exploratory.

Trend analysis and story discovery

• Stay current on relevant breakthroughs across AI, drug discovery, chemistry, materials science, automation, and compute.
• Proactively identify timely story angles that reinforce Lila’s mission and help audiences understand the broader landscape.

What Success Looks Like

• Lila’s science and platform are explained with a voice that is credible to experts and clear to non-specialists.
• Stakeholders can quickly understand Lila’s “so what,” without sacrificing accuracy.
• A dependable editorial pipeline exists: contractors produce faster with fewer revisions, and internal reviewers trust the process.
• Core narratives travel across formats and channels, increasing understanding, trust, and interest among customers, partners, government stakeholders, investors, and candidates.

What You’ll Need to Succeed

• Bachelor’s or Master’s degree in life sciences, chemistry, materials science, journalism, or a related field. PhD candidates or holders are highly encouraged to apply.
• Proven experience as a science writer or journalist, with a portfolio including work published in reputable outlets (for example: Nature, Wired, Chemical & Engineering News, or similar).
• Strong ability to explain complex scientific concepts to diverse audiences without losing technical integrity.
• Experience managing or leading a team of writers (including contractors) preferred.
• Ability to create or manage creation of visual/multimedia content (graphics, photos, video) is a significant plus.
• Exceptional written and verbal communication skills, with a keen eye for detail.

Your Impact at LILA

We are seeking a strategic Product Marketing Manager (Life Science) to own go-to-market for Lila’s life science product portfolio. You’ll translate complex, closed-loop AI and lab capabilities—such as mRNA design, DNA construct optimization, and AI-driven medicinal chemistry—into clear, credible stories and compelling commercial offerings for:

• Biopharma and advanced therapy companies
• R&D and CMC leaders
• Data science / AI teams and scientific IT

In collaboration with the Life Science Product team, you will shape RNA and DNA design technology tiles, hit-to-lead and lead optimization offerings, and early commercial pilots. Your work will define positioning, launch plans, and evidence strategies that move prospects from curiosity to committed programs. You’ll articulate value, build differentiated narratives, and enable cross-functional execution across product, sales, and customer success to accelerate adoption and drive measurable business impact.

What You'll Be Building

Messaging & Positioning

• Define and continuously refine product narratives for Lila’s life science capabilities (RNA/mRNA design, DNA constructs, protein and small molecule optimization, AISF-powered workflows).
• Tailor messaging to specific personas (Heads of R&D, Therapeutic Area leaders, CMC, translational and bioinformatics leads, Scientific IT) and use cases (hit-to-lead, mRNA design, in vivo CAR-T data stories).
• Ensure all external materials reflect Lila’s master narrative on scientific superintelligence, safety, and multi-domain learning.

Go-To-Market Strategy & Launch

• Lead end-to-end GTM for new life science capabilities: from beta/pilot framing through general availability and expansion.
• Partner with Product, Commercial, and BizOps to define offer constructs (pilot scopes, pricing guardrails, AISF access models) and map the customer journey from first meeting to signed programs.
• Align roadmap milestones (new RNA/DNA or medicinal chemistry capabilities, app workflows) with external launch moments, events, PR, and sales cycles.

Content & Evidence Creation

• Produce technical and visionary content that makes capabilities tangible:
  • Use case briefs, technical one-pagers, solution guides
  • Decks for customer pitches, partner discussions, and scientific meetings
  • Blog posts, webinar scripts, demo narratives, and explainer videos in partnership with Brand/Creative
• Collaborate with Life Science (LS) Product, science, and commercial teams to turn pilots and tech tiles into case studies showing real impact

What You’ll Need to Succeed

Education

• Bachelor’s degree in Life Sciences, Bioengineering, Data Science, or a related field. MS/PhD a plus.

Experience

• 5+ years in Product Marketing or closely related roles at a B2B SaaS, life sciences technology, or AI/ML company, ideally supporting discovery, translational, or CMC/R&D teams.

Domain Expertise

• Working knowledge of the life science value chain (discovery → preclinical → early development; RNA/DNA/protein or small molecule workflows).
• Familiarity with lab automation, assay platforms, FAIR data principles, and AI/ML in drug discovery or therapeutics.

Technical Fluency

• Comfortable engaging with AI scientists, bench scientists, and engineering/IT stakeholders; able to translate closed-loop AI and AISF concepts into clear business value.

Communication & Storytelling

• Exceptional writing and presentation skills, with a track record of content targeting scientific and technical audiences.

Cross-Functional Collaboration

• Proven success partnering across Product, Sales/BD, and Marketing; able to influence without formal authority.

Startup Mindset

• Thrives in a fast-moving, highly cross-functional environment where both the product and category are evolving.

Bonus Points For

• PHD is a plus

Position Overview:

Beam is looking for a Senior Manager/Associate Director of statistical programming to join our growing Statistical Programming team in the Biometrics department. This individual will be responsible for developing and maintaining statistical programming functions within a therapeutic area to support various clinical studies and submissions to ensure successful execution for Beam’s clinical programs. In this role, you will work with the head of statistical programming and the head of biometrics to develop statistical programming strategies, SAS programming infrastructure as well as department standards, applications and processes. You will manage CROs, oversee programming activities and provide timely support to the cross-functional teams on statistical programming matters according to the project strategies and requests.

Responsibilities:

• Lead and manage statistical programming activities on clinical studies and oversee CROs to generate analysis data sets and tables, listings and figures needed for clinical study reports and regulatory submissions.
• Review and validate SDTM, ADaM analysis datasets and TFLs created by CROs.
• Work collaboratively and communicate effectively with Biostatistics, Data Management, clinical operations, clinical development, Regulatory and other functions.
• Manage creating CDSIC SDTM and ADaM datasets, analysis metadata results and Define.xml for Electronic Submission from the clinical database or external data sources.
• Manage the activities of data summary, statistical analysis, patient profile, safety and efficacy tables, listings and figures using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS and R.
• Oversee and manage the workflow of generating study specific and ad-hoc clinical data listings, summary tables and figures.
• Partner with Statisticians and other members of the clinical study team, perform ad hoc analysis.
• Review SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents by CROs and provide expert feedback from functional perspective.
• Assist the Head of Statistical Programming in reviewing bid proposals, monitoring and tracking budgets for outsourced activities.
• Assist the Head of Statistical Programming to develop and implement programming processes, programming standards and SOPs.
• Develop SAS programming infrastructure and programming processes to improve data deliverables and ad hoc analyses quality and efficiency.
• Build and mentor a team of programmers as needed to support Beam clinical trials and drug development pipelines.

Qualifications:

• MS or higher degree in Statistics, Mathematics, or related scientific Discipline.
• At least 12 years Pharmaceutical/Biotech programming experience.
• Advanced SAS programming skills and strong Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
• Experience and in-depth knowledge in CDISC including STDM, ADaM and controlled terminologies.
• NDA or BLA submission experience is required.
• Excellent organizational skills and ability to prioritize tasks.
• Excellent communication and interpersonal skills.
• Experience managing CROs and other data vendors.
• Knowledge of ICH guidelines, Good Clinical Practices, FDA / EMA / other regulatory authority guidance.
• Experience with R-Shiny or Python is a plus.

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

ABOUT PIONEERING MEDICINES

Pioneering Medicines, Flagship Pioneering’s in-house drug development unit, is dedicated to conceiving and developing a broad portfolio of life-changing treatments for patients built from Flagship’s innovative platforms. Harnessing the drug development expertise of its team together with the power of Flagship's multiple scientific platforms, Pioneering Medicines explores and identifies new product concepts which are then advanced jointly with Flagship’s bioplatform companies. Within Flagship’s Innovation Supply Chain partnerships, Pioneering Medicines works with external collaborators to apply its unique approach to partners’ R&D priorities. These partnerships are highly co-creative strategic alliances that accelerate therapeutic innovation by bringing together partners spanning the full spectrum of drug discovery, development, and production.

Position Summary 

The Senior Director, Head of Toxicology will lead and build the toxicology function within Pioneering Medicines, defining and executing nonclinical safety strategies across a diverse and rapidly evolving portfolio. This role provides scientific and strategic leadership across both investigative and regulatory toxicology, supporting a broad range of therapeutic modalities. 

Working in a dynamic venture creation environment, you will collaborate closely with multidisciplinary teams to optimize candidate selection, guide preclinical development, and ensure regulatory readiness. This is a high-impact role requiring strong analytical thinking, scientific rigor, and clear communication, influencing programs from discovery through early clinical development. 

Key Responsibilities 

Functional Leadership & Capability Building 

• Lead, build, and scale the toxicology function, including internal team development and external partnerships  

• Define fit-for-purpose operating models spanning investigative and regulatory toxicology  

• Serve as the primary internal expert for nonclinical safety, ensuring quality, consistency, and scalability across the portfolio  

Portfolio & Program Strategy 

• Define and drive toxicology strategies across multiple programs and modalities   

• Translate findings into clear risk assessments, mitigation strategies, and IND/CTA-enabling plans  

• Enable transparent, data-driven decision-making by articulating risks, assumptions, and trade-offs to program teams  

• Oversee the design, execution, and interpretation of non-GLP and GLP toxicology studies  

• Partner cross-functionally (DMPK, pharmacology, CMC, clinical) to integrate safety into development strategy  

• Support diligence and evaluation of new programs within Flagship’s ecosystem  

External Partnerships & Regulatory 

• Build and manage a high-performing CRO and consultant network, ensuring quality, timelines, and cost efficiency  

• Leverage and contribute to the Flagship ecosystem, fostering knowledge sharing and collaboration across platform companies  

• Lead nonclinical regulatory strategy and documentation (INDs, IBs, briefing materials)  

• Ensure regulatory readiness through clear and scientifically robust safety narratives  

• Represent toxicology in regulatory interactions as appropriate  

Qualifications 

• PhD, DVM, or equivalent in Toxicology, Pathology, Pharmacology, or related field  

• ~10-15+ years of experience in nonclinical safety in biotech/pharma  

• Proven track record advancing programs through IND and into clinical development  

• Experience across multiple modalities preferred  

• Strong experience managing CROs and external collaborations  

• Experience leading or building a toxicology function or team, including management of internal scientists and/or external partners, is a plus  

Leadership Profile 

• Enterprise mindset; able to operate across a portfolio in a fast-paced, collaborative environment  

• Analytical and goal-oriented, with the ability to operate with urgency while maintaining high standards of scientific rigor and ethics  

• Strong communicator who can translate complex toxicology into clear, audience-appropriate risk assessments, from early-stage teams to large pharma partners  

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 - $280,000. 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.

The Opportunity

The Director Clinical Science will be a key member of the Clinical Development team with responsibilities to provide scientific support for ongoing activities. This role will report to a Medical Director and will collaborate cross functionally with R&D, program management, clinical operations, biostatistics, and data management. The selected candidate will support and drive key development activities for clinical studies and overall execution of program Clinical Development Plans (CDP).

Responsibilities

• Collaborates with the clinical development team in review, analysis, and interpretation of study results.
• Provides scientific support on ongoing Phase I to III clinical trials and contributes to the planning and design of upcoming clinical studies.
• Performs monitoring and review of study data including labs, safety data, and patient eligibility.
• Authors and/or reviews clinical trial-related documents including protocols, CRF, informed consent, protocol deviations, monitoring plans and regulatory documents, etc.
• Contributes to regulatory documents including CSRs, Investigator’s Brochures, and Clinical sections of INDs, CTAs.
• Interacts with external medical/scientific advisors, thought leaders and clinical investigators in the therapeutic areas as well as with internal management and drug development staff to prepare/revise/maintain and efficiently execute the clinical development plan.

Required Qualifications

• Advanced degree (M.D., Ph.D., Pharm.D., Master’s Degree in Science/Medical-related field).
• MD, PhD or PharmD with 3+ years Clinical Research, Pharmaceutical, or CRO experience, OR Master’s degree with 8+ years of relevant experience.
• Knowledge of Phase 1-3 drug development.
• Knowledge of clinical trial implementation and sponsor/site interactions for clinical trials.
• Prior experience working within neurology or neurodegenerative indications.
• Well-versed in relevant applications of GCP (Good Clinical Practice), ICH, FDA, EMEA and other relevant guidelines and regulations.
• Strong, collaborative team-player.
• Excellent attention to detail and communication skills.

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 salary range for this role is $360,000 - $415,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Montai Therapeutics currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Montai Therapeutics's good faith estimate as of the date of publication and may be modified in the future.

The salary range for this role is $360,000 - $415,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Montai Therapeutics currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Montai Therapeutics's good faith estimate as of the date of publication and may be modified in the future.

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 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.

Why Join Us?

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock 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 candidate, FOG-001, is the first direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in colorectal cancer, desmoid tumors, and a range of other Wnt/β-catenin-driven tumors. Parabilis is also advancing investigational degraders of ERG and ARON for the treatment of prostate cancer, as well as other preclinical programs. 

What’s the opportunity?

We are seeking an experienced industry nonclinical pharmacology leader with a demonstrated track record of advancing oncology programs from discovery through IND submission. This role will serve as the nonclinical pharmacology lead on one or more oncology programs, accountable for nonclinical pharmacology strategy, including translational planning and IND-enabling study design, and contributing to regulatory pharmacology content. You will be expected to meaningfully contribute to regulatory filings and identify translational forward approaches that target early clinical development goals.

Your leadership experience and history of working in a highly matrixed cross functional environment will be key in continuing to move oncology programs forward in a collaborative and scientifically rigorous environment. You will work within the existing pharmacology team framework and report directly to the Head of Pharmacology. Success in this role will require excellent communication, scientific thought leadership, a desire to work in a fast paced team environment and an eagerness to grow as a drug hunter.

Key abilities of this role include:

• Lead nonclinical pharmacology strategy for assigned oncology programs from late discovery through IND submission
• Design, oversee, interpret, and communicate in vivo PK/PD and efficacy studies (internally and via CRO partnerships)
• Contribute to IND-enabling study design and author or co-author relevant pharmacology sections of regulatory submissions
• Integrate pharmacology data with DMPK, safety, and biomarker findings to inform development decisions
• Clearly present data and strategy updates to senior leadership and governance teams
• Inspire and mentor junior pharmacology team members

What you’ll need to be successful:

• PhD. in Pharmacology, Biology, or related field with 8+ years post-degree experience with a minimum of 2+ years of program leadership and people management experience
• Experience supporting first-in-class or novel mechanism oncology programs
• Experience working with small molecules, peptides, degraders (e.g., PROTACs), or biologics
• Demonstrated success advancing at least one oncology program to development candidate nomination; experience contributing to an IND submission required
• Strong expertise in in vivo pharmacology, PK/PD modeling concepts, and mechanistic biomarker strategy
• Proven ability to independently design and interpret studies that support program milestones
• Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected, and advanced or innovated use of AI is a strong plus
• Able to work on-site and attend in-person meetings
• Enthusiastic and innovative mindset with the ability to thrive in a dynamic, fast-pasted, and highly collaborative environment
• Excellent communication, organization, multi-tasking, flexibility, and team skills.

Core Values

Parabilis 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 target for this position is $165,000 - $200,000 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.

Why Join Us?

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock 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 AR^ON 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 Research Equipment Lead is responsible for enabling Parabilis’ cutting-edge research by ensuring laboratory equipment is strategically selected, optimally configured, highly reliable, and continuously improving. This role owns the full lifecycle of research instrumentation and partners closely with Research, Finance, Facilities, IT, Quality, and external vendors to minimize downtime, enable automation, and support scalable, reproducible science.

This position requires deep and broad technical expertise across research equipment platforms, strong operational rigor, and the ability to integrate automation, data, and AI-driven approaches into lab operations. The Research Equipment Lead plays a critical role in aligning equipment strategy with scientific roadmaps, growth plans, and financial and regulatory requirements.

Equipment Lifecycle & Operational Excellence

• Own the full lifecycle of research equipment, from needs assessment and acquisition through installation, operation, maintenance, and retirement, ensuring high availability and performance across research groups.
• Oversee day-to-day equipment operations, including troubleshooting, repairs, and preventive maintenance programs to minimize downtime and disruption to research.
• Lead installation, qualification, validation, and calibration of laboratory instruments in coordination with vendors, Facilities, IT, and internal stakeholders, applying continuous improvement principles.
• Maintain comprehensive, audit-ready documentation, including equipment inventories, maintenance logs, calibration records, service contracts, and validation documentation, in alignment with internal policies and applicable regulatory expectations.
• Establish and monitor key performance indicators (KPIs) for equipment reliability, utilization, and downtime.

Training, Partnership & Vendor Management

• Serve as the primary point of contact for equipment-related issues across research labs.
• Develop and deliver technical training to ensure safe, effective, and compliant use of laboratory instruments.
• Build strong cross-functional partnerships with Research, Facilities, IT, Quality, Procurement, and Finance to ensure seamless equipment support and alignment.
• Manage vendor relationships, including service agreements, performance reviews, and escalation of technical issues.

Equipment Strategy, Automation & Capital Planning

• Partner with R&D leadership to forecast equipment, automation, and digital infrastructure needs aligned with scientific strategy, growth plans, and budget constraints.
• Collaborate with Finance on capital planning, asset tracking, depreciation, and accounting requirements for research equipment.
• Evaluate emerging technologies, automation platforms, and AI-enabled tools; recommend capital investments that improve efficiency, scalability, data quality, and reproducibility.
• Identify opportunities to implement laboratory automation, robotics, and software-driven workflows, including the use of AI or data analytics to optimize equipment performance, scheduling, predictive maintenance, and experimental throughput.
• Contribute to the design or customization of novel or integrated instrumentation solutions to support next-generation research.

What you’ll need to be successful:

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Physics, or a related technical discipline; advanced degree preferred.
• 5-7+ years of hands-on experience supporting and maintaining complex research laboratory equipment across multiple scientific functions.
• Demonstrated expertise in equipment lifecycle management, preventive maintenance programs, and vendor coordination.
• Working knowledge of relevant scientific, engineering, operational, safety, and regulatory principles applicable to research laboratories.
• Strong organizational skills with exceptional attention to detail and documentation rigor.
• Proven ability to collaborate cross-functionally and communicate effectively with technical and non-technical stakeholders.
• Experience implementing laboratory automation, robotics, or digitally enabled workflows.
• Familiarity with AI- or data-driven approaches to equipment monitoring, utilization, or predictive maintenance.
• Experience partnering with Finance on capital equipment planning, budgeting, and accounting processes preferred.
• Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected, and advanced or innovated use of AI is a strong plus
• Able to work on-site and attend in-person meetings

Core Values

Parabilis 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 target for this position is $86,000-$110,000 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 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.

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:

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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