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 millionin 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 build, 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.
• Ensure proactive risk management and compliance with local and international PV regulations
• Drives safety related content of regulatory submissions including reference safety information/IB, protocol, informed consent (DSURs, RMPs), and responses to health authorities
• Leads policy discussions to assure communication of benefit-risk considerations and safety surveillance activities including routine review of safety data to detect and evaluate safety signals.
• Oversee 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
• Serves as Generate's PV point of contact in regulatory meetings, inspections and internal audits.
• Serve as key member of safety governance committees, including presentation of safety issues, signal evaluations and proposed risk mitigation strategies.
• 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.
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical/pharmaceutical information and safety data to both healthcare professionals (HCPs) and non-HCPs.
• 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-edge biotech redefining drug discovery through Generative Biology™. You’ll ensure the highest safety standards while helping deliver transformative therapies to patients.

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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.