Crescent Biopharma
Vice President, Pharmacovigilance
Waltham, MA · Exec
Sponsorship not specified$323k-$357kDetected 13 days ago
Product ManagementFDA RegulatoryPharmacovigilanceLeadershipCollaborationRegulatory Affairs
About the role
- For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
- This role may be based in a hybrid capacity from our Waltham, MA office or remotely from the East Coast.
- This includes being responsible for the strategic oversight and execution of all safety and pharmacovigilance activities, ensuring compliance with global regulatory standards.
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.
- Oversee the preparation and review of safety documents, including DSURs, safety reports, and clinical development documentation.
- 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.
- Strong leadership skills with the ability to mentor teams and lead cross-functional initiatives.
- The Company's clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates.
Requirements
- M.D., D.O., or M.B.B.S. required.
- This role is based in Waltham, MA and you must have experience in the oncology space.
Nice to have
- BLA/NDA experience highly preferred
Compensation
- $323k-$357k
Benefits
- Crescent Biopharma's vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients.
- Reporting directly to the Chief Medical Officer (CMO), you will be leading and building out the Safety and PV.
- This involves providing strategic medical oversight, managing safety data, and guiding cross-functional collaboration to integrate safety into all phases of our product lifecycle.
- Lead all pharmacovigilance activities for our products, including safety surveillance, signal detection, and risk-benefit assessments.
- Provide strategic safety insights to the CMO and Executive Leadership Team, particularly regarding the risk-benefit profile of company products.
- 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.
- Education & Experience
Company info
- We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected.
Equal opportunity
- Equal Opportunity Employer.
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This listing is sourced directly from Crescent Biopharma's careers page and normalized into a canonical job model.