--- title: 'Vice President, Pharmacovigilance at Crescent Biopharma' canonical: 'https://feeny.ai/job/vice-president-pharmacovigilance-crescent-biopharma-waltham-47ss86sacfsv' type: 'job' last_seen: '2026-10-15' --- # Vice President, Pharmacovigilance at Crescent Biopharma - **Company:** Crescent Biopharma - **Location:** Waltham, MA - **Compensation:** $323k–$357k - **Employment:** full-time - **Work type:** onsite - **Posted:** 2026-07-09 - **Last confirmed live:** 2026-10-15 - **Apply:** https://jobs.lever.co/crescent-biopharma/8e8ed32a-5d55-4b7e-9ae2-ba5b94629926 ## 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 as single agents and as part of combination regimens to treat a range of solid tumors. For more information, 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 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 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. ## About Crescent Biopharma ## Company Overview - **One-liner**: Crescent Biopharma is a clinical-stage oncology company developing next-wave cancer therapies, including a PD-1 x VEGF bispecific antibody and antibody-drug conjugates (ADCs) for solid tumors. - **Entity Type**: Public (IPO in June 2025; ticker not disclosed in available data) - **Headquarters**: Waltham, Massachusetts, United States (300 Fifth Avenue, Waltham, MA 02451) - **Founded**: Year not publicly available (company appears to have been active before 2024; IPO in 2025) - **Founders**: Not publicly available (leadership includes CEO Joshua Brumm, but founder information is not listed) ## Core Business - **Primary industry/industries**: Oncology biotechnology / Therapeutics - **Target customers**: B2B – primarily focuses on developing and commercializing cancer therapies, with partnerships and collaborations (e.g., Kelun-Biotech, Paragon Therapeutics) - **Mission or purpose statement**: “Delivering the next wave of transformative therapies to bring a brighter future for people living with cancer.” ## Products & Services - **CR-001 (PD-1 x VEGF bispecific antibody)**: A tetravalent bispecific antibody in Phase 1/2 clinical trials (ASCEND) for advanced solid tumors. Designed to exhibit cooperative pharmacology similar to ivonescimab; aims to restore T-cell activity and localize anti-VEGF activity in the tumor microenvironment. Collaboration with Kelun-Biotech for Greater China rights. - **CR-002 (PD-L1–directed ADC)**: A topoisomerase inhibitor ADC targeting PD-L1, with high internalization. IND planned for mid-2026, with Phase 1/2 trial expected in H2 2026. - **CR-003 (ITGB6–directed ADC)**: A differentiated ADC targeting integrin beta-6 (ITGB6), with a topoisomerase 1 inhibitor payload. Uses Kthiol conjugation technology. Licensed from Kelun-Biotech for ex-Greater China markets; Phase 1/2 trial ongoing in China. ## Market Standing - **Valuation/Market Cap**: Not disclosed (public company as of 2025, but no valuation or market cap figure available in provided data) - **Key Metric**: Total Funding: $585M (including $200M Series A in 2024, $185M Post-IPO Equity in 2025, and $200M Post-IPO Equity in 2025 led by Fairmount Funds Management) - **Notable Investors/Partners**: Fairmount Funds Management, Venrock Healthcare Capital Partners, Kelun-Biotech (strategic collaboration), Paragon Therapeutics - **Growth Signals**: Headcount grew 129.6% YoY to 55 employees (LinkedIn); IPO in June 2025; multiple pipeline programs advancing toward IND; expansion into ADC combination trials ## Competitive Advantages - Focus on established, clinically validated targets (PD-1, VEGF, PD-L1, ITGB6) to reduce risk and accelerate development - Multi-modality approach (bispecific antibodies + ADCs) enabling combination therapies with potential synergistic effects - Proprietary ADC technology (Kthiol conjugation) and strategic collaborations for global rights to differentiated assets - Strong leadership team with deep oncology drug development expertise (former executives from major biopharma) ## Strategic Focus - Advance CR-001 as a foundational backbone therapy, with initiation of combination trials with ADCs in H2 2026 - Submit IND for CR-002 in mid-2026 and begin Phase 1/2 trials - Progress CR-003 clinical program and explore additional internal and partnered ADC and immuno-oncology opportunities - Build a leading oncology company through disciplined execution, leveraging established biology and multiple modalities ## Why Work Here - **Culture highlights**: “No egos, collaborative spirit,” “roll up sleeves,” “move with urgency,” “data-driven science with patients as true north.” Emphasizes transparency, integrity, and impact. - **Remote/hybrid/office policy**: Not explicitly stated; headquarters in Waltham, MA, with an office in Rockville, MD. Likely requires on-site presence given the “highly collaborative” and “urgent” culture. - **Notable perks**: 100% employer-paid medical, dental, vision, short/long-term disability, life insurance; HSA and dependent care FSA; 401(k); subsidized lunch program; flexible vacation and paid holidays including summer and year-end office closures (one week each). - **Best for**: Bold innovators who want to make a significant impact in oncology drug development, thrive in a fast-paced, transparent environment, and are motivated by patient outcomes. ## Sources 1. [crescentbiopharma.com – Careers](https://www.crescentbiopharma.com/careers/) 2. [crescentbiopharma.com – About](https://www.crescentbiopharma.com/about/) 3. [crescentbiopharma.com – Pipeline](https://www.crescentbiopharma.com/pipeline/) 4. [linkedin.com – Crescent Biopharma](https://www.linkedin.com/company/crescent-biopharma) 5. 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