Vice President, Head of Pharmacovigilance

About Generate:Biomedicines

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role:

Generate:Biomedicines is seeking a strategic and visionary Vice President, Head of Pharmacovigilance (PV), to lead our global safety function across all stages of development. Reporting to the Chief Medical Officer, this enterprise leader will shape and drive the PV strategy, infrastructure, and culture for both early and late-stage programs. The VP will oversee a high-impact team, including the Senior Director of PV, while scaling systems and partnerships that ensure patient safety, regulatory excellence, and innovation. This role requires broad influence across internal and external stakeholders, including regulatory bodies, to support the successful advancement of Generate's growing therapeutic portfolio.

Here's how you will contribute:

• Set and execute the global pharmacovigilance strategy in alignment with Generate’s clinical and corporate objectives.
• Provide enterprise-level leadership for all PV operations including signal detection, risk management, safety surveillance, and regulatory reporting.
• Ensure strategic oversight of safety input into clinical protocols, CSRs, benefit-risk assessments, informed consent, and regulatory interactions.
• Oversee authoring and review of aggregate reports (DSURs, RMPs), IBs, and regulatory responses.
• Lead inspection readiness and compliance across global PV systems, vendors, and CROs.
• Serve as senior safety representative in regulatory meetings, inspections, and health authority interactions.
• Chair or participate in executive safety committees, including Safety Governance and DSMBs.
• Partner cross-functionally with Clinical, Regulatory, Biostats, Quality, and Medical Affairs to align on safety strategy.
• Support CMO in addressing bioethical issues, including policies on data sharing, compassionate use, and access to investigational products.
• Recruit, develop, and retain top PV talent; mentor senior leaders to build scalable team capacity.

The Ideal Candidate will have

• MD required.
• 15+ years in pharmacovigilance or drug safety, with a strong track record of leadership in both early and late-stage development.
• Deep knowledge of GCP, GVP, and global PV regulations.
• Experience leading global safety strategies for biologics, ideally in immunology or rare disease.
• Demonstrated success in building and scaling PV teams and systems in biotech.
• Strong organizational leadership, influencing, and communication skills.
• Proven experience engaging with global regulatory authorities and inspections.

Nice to Have 

• Experience in high-growth or platform biotech environments.
• Background in respiratory or rare disease programs.

Why Join Us
This is a rare opportunity to architect the future of safety at a trailblazing biotech redefining what’s possible in drug discovery through Generative Biology™. As VP, you will lead a function critical to our mission of delivering transformative therapies safely and ethically to patients around the world.

#LI-HM1

Generate:Biomedicines is 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: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.