Executive Director, 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 visionary Executive Director, Head of Pharmacovigilance (PV), to lead and scale the company’s global safety organization through all stages of drug development. Reporting to the Chief Medical Officer of Inflammation & Immunology, this individual will oversee the end-to-end PV strategy, operations, and compliance across early and late-stage clinical programs. This leader will manage the Senior Director of Pharmacovigilance and a growing internal and external team, ensuring regulatory alignment, scientific excellence, and patient safety. The role is a strategic leadership opportunity to shape the safety culture and infrastructure at a rapidly growing biotech.

Here's how you will contribute:

• Set and lead the pharmacovigilance strategy and roadmap for Generate’s clinical and development programs.
• Provide scientific and regulatory oversight of all PV activities including signal detection, risk assessments, safety surveillance, and regulatory submissions.
• Oversee development and delivery of aggregate safety reports (DSURs, RMPs), core safety information (IBs, safety narratives), and responses to health authorities.
• Guide safety input into clinical protocols, CSRs, informed consent documents, and benefit-risk assessments.
• Manage pharmacovigilance vendors and CROs to ensure consistent quality and inspection readiness.
• Build and evolve internal PV processes, systems, and SOPs in collaboration with Quality, Regulatory, and Clinical Operations.
• Collaborate cross-functionally with Clinical, Clinical Operations, Regulatory, and Biostatistics.
• Collaborates with medical to define risk-benefit profiles
• Support CMO to address bioethical issues and develop corporate policies related to clinical trials (e.g., data sharing, compassionate use requests, access to investigation product, protecting vulnerable populations)
• Represent Generate in regulatory meetings and inspections related to safety and pharmacovigilance.
• Serve as chair or key member of safety governance committees and support DSMB.
• Mentor and grow a high-performing PV team, including the Sr. Director of PV and future leaders.

Leadership Responsibilities:
Aligned with Generate’s "Leading Organization" model, the Executive Director will:

• Drive a culture of scientific excellence, compliance, and patient focus.
• Establish scalable systems for global PV operations and team growth.
• Communicate clearly and courageously across all levels of the organization.
• Develop cross-functional alignment on safety strategy and ensure transparency.

The Ideal Candidate will have:

• MD required.
• 10+ years of experience in pharmacovigilance or drug safety, with at least 2-3 years in leadership roles spanning early and late-stage development.
• Strong knowledge of GCP, GVP, and global PV regulations.
• Expertise in biologics and experience in multiple therapeutic areas, including immunology.
• Proven success leading PV teams and cross-functional safety strategies.
• Experience in regulatory authority interactions and inspections.
• Strong organizational, decision-making, and communication skills.

Nice to Have (Optional)

• Experience building PV functions in a high-growth biotech.
• Background in respiratory or rare disease programs.

Who Will Love This Job: 

This is a rare opportunity to shape the safety function of a cutting-ed