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 leading and building out the Safety and PV. This includes being 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 involves 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. Your role will include 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 you must have experience in the oncology space.
Responsibilities
- Lead and build our 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
Skills Required
- M.D., D.O., or M.B.B.S.
- 15+ years of global experience in oncology drug safety within biotechnology or pharmaceutical industry
- BLA/NDA experience
- In-depth knowledge of FDA safety regulations, ICH Guidelines, NMPA, and other global safety regulations
- Deep understanding of risks and risk mitigation 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 ability to mentor teams and lead cross-functional initiatives
- Excellent written, verbal, and presentation skills
- Experience in the oncology space
- Role based in Waltham, MA (hybrid or East Coast remote noted)
What We Do
Crescent Biopharma, Inc. is a clinical-stage biotechnology company dedicated to advancing the next wave of transformative therapies for cancer patients. The company focuses on developing high-impact cancer medicines, including its lead program, CR-001 (a PD-1 x VEGF bispecific antibody), and a portfolio of novel antibody-drug conjugates (ADCs) designed to treat a range of solid tumors.
