Vice President, Pharmacovigilance

Crescent Biopharma; Waltham (MA); On-site; USD 323,000 - 357,000; Full time

Benefits offered by this job

100% employer-paid benefits

Flexible PTO

Equity

Hybrid work model

Professional development opportunities

Job summary

Crescent Biopharma is seeking a strategic leader to serve as Vice President of Pharmacovigilance, responsible for patient safety and PV strategy. The role can be hybrid from the Waltham, MA office or remote from the East Coast, reporting to the CMO.

You will lead safety data management, regulatory interactions, and cross-functional collaboration to integrate safety across the product lifecycle. Experience in oncology is required.

Qualifications

• MD/DO/MBBS or equivalent required with extensive global oncology safety experience.
• 15+ years of global experience in oncology drug safety.
• Familiarity with FDA safety regulations, ICH guidelines, NMPA and other global safety regulations.
• BLA/NDA experience highly preferred.
• Expert knowledge of safety databases (Veeva, ARGUS, IQVIA) and safety signal detection.
• Strong leadership with the ability to mentor teams and drive cross-functional initiatives.
• Excellent written, verbal, and presentation skills, with the ability to influence senior leadership and external stakeholders.

Responsibilities

• Lead and build the Safety and Pharmacovigilance function.
• Establish and maintain a safety and pharmacovigilance infrastructure prioritizing safety by design.
• Lead pharmacovigilance activities including safety surveillance, signal detection, and risk-benefit assessments.
• Serve as primary PV contact for regulatory authority interactions and safety service provider management.
• Provide strategic safety insights to the CMO and Executive Leadership Team.
• Oversee the preparation and review of safety documents (DSURs, safety reports, development documentation).
• Represent PV in interactions with FDA, NMPA, EMA and other health authorities, including inspections.
• Ensure compliance with global safety regulations and lead responses to safety inquiries.
• Manage PV budget and resources (internal and external).
• Drive continuous improvement in PV practices and readiness for inspections and audits.
• Collaborate with Clinical Development, Regulatory Affairs, and Quality to integrate safety into strategy.
• Represent the company externally and build safety partnerships with industry.

Skills

Leadership

Cross-functional collaboration

Safety/regulatory expertise

Communication skills

Education

MD/DO/MBBS

15+ years oncology PV experience

Tools

Veeva

ARGUS

IQVIA

Job description

Crescent Biopharma’s vision is to build a world‑leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical‑stage pipeline includes its lead program, a PD‑1 x VEGF bispecific antibody, as well as novel antibody‑drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. Visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

We are seeking a strategic leader, Vice President of Pharmacovigilance, to lead patient safety and pharmacovigilance needs, fostering a culture where safety is integrated into every aspect of our drug development process. This role may be based in a hybrid capacity from our Waltham, MA office or remotely from the East Coast. Reporting directly to the Chief Medical Officer (CMO), you will be responsible for the strategic oversight and execution of all safety and pharmacovigilance activities, ensuring compliance with global regulatory standards.

As the VP, Head of Safety and Pharmacovigilance, you will lead our efforts in ensuring the safety of our investigational products. This includes providing strategic medical oversight, managing safety data, and guiding cross‑functional collaboration to integrate safety into all phases of our product lifecycle. You will be responsible for creating and building the function, interacting with regulatory authorities, leading the pharmacovigilance team, and overseeing the activities of external safety service providers. This role is based in Waltham, MA and requires experience in the oncology space.

Responsibilities

• Lead and build the Safety and Pharmacovigilance function.
• Establish and maintain a safety and pharmacovigilance infrastructure that prioritizes safety by design in all development activities.
• Lead all pharmacovigilance activities for our products, including safety surveillance, signal detection, and risk‑benefit assessments.
• Serve as the primary contact for safety‑related issues, including regulatory authority interactions and safety service provider management.
• Provide strategic safety insights to the CMO and Executive Leadership Team, particularly regarding the risk‑benefit profile of company products.
• Oversee the preparation and review of safety documents, including DSURs, safety reports, and clinical development documentation.
• Serve as the primary PV representative in interactions with FDA, NMPA, EMA, and other global health authorities, including Type B/C meetings, health authority safety queries, and pharmacovigilance inspections.
• Ensure compliance with global safety regulations and guidelines and lead responses to safety‑related inquiries from regulatory authorities.
• Manage the pharmacovigilance budget and resources, including both internal teams and external contractors.
• Drive continuous improvement in pharmacovigilance practices, ensuring readiness for regulatory inspections and audits.
• Collaborate with cross‑functional teams, including Clinical Development, Regulatory Affairs, and Quality, to integrate safety considerations into company strategy.
• Represent the company externally, building relationships with industry leaders and vendors to enhance our safety and pharmacovigilance capabilities.

Education & Experience

• M.D., D.O., or M.B.B.S. required.
• 15+ years of global experience in oncology drug safety within the biotechnology or pharmaceutical industry.
• BLA/NDA experience highly preferred.
• In‑depth knowledge of FDA safety regulations, ICH Guidelines, NMPA, and other global safety regulations.
• Deep understanding of risks and risk‑mitigation steps related to safety signals and pharmacovigilance.
• Expert knowledge of safety database applications (e.g., Veeva, ARGUS, IQVIA) and safety signal detection.
• Strong leadership skills with the ability to mentor teams and lead cross‑functional initiatives.
• Excellent written, verbal, and presentation skills, with the ability to influence senior leadership and external stakeholders.

What We Offer

• Opportunity to join a mission‑driven team where you’ll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment.
• Competitive compensation, including base salary, performance bonus, and equity.
• 100% employer‑paid benefits package.
• Flexible PTO; also, two one‑week company‑wide shutdowns each year.
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities.

$323,000 - $357,000 a year

Additional Description for Pay Transparency: The final salary offered will depend on several factors, which may include, but are not limited to, relevant years of experience, educational background, and geography. Eligible employees and/or eligible dependents are eligible to participate in the following company‑sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability. Employees are eligible to participate in the Company’s savings plan (401(k)) and long‑term incentive program. Eligible time‑off benefits include unlimited PTO, 10 sick days per calendar year, holiday pay (including two company shutdowns), 16 weeks parental leave within one year of birth/adoption/foster care, FMLA, and military leave. Further information can be found at https://www.crescentbiopharma.com/careers/#benefits.

Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.