Director, Safety Science

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: 

The Director, Safety Science will join a small but growing pharmacovigilance (PV) team.  This will be an individual contributor to start and may have the opportunity to grow their team over time.  The ideal candidate will be comfortable operating in a dynamic, fast-paced environment, balancing strategic planning with hands-on execution of safety science deliverables across our clinical-stage pipeline.  Responsibilities include providing strategic scientific and operational PV support for clinical development products in the Generate portfolio, including those transitioning from early to late-phase development.  This Director, Safety Science will contribute to a full range of PV activities including but not limited to oversight and management of safety reports and safety data signal management activities, PV organization and process development, inspection readiness and PV vendor management.  You will also partner closely with Clinical, Regulatory, Medical, Biostats, and external partners to ensure proactive signal detection and safety risk management in alignment with global regulatory expectations.

Here's how you will contribute:

• Assess and interpret safety data from a variety of sources for assigned products
• Perform aggregate data review, signal detection and evaluation using safety databases, literature, and clinical data.
• Perform individual case safety report assessments for clinical trial safety reports, including review of Analysis of Similar Events, as applicable
• Establish and facilitate internal cross-functional Safety Management Teams and/or other safety governance/review meetings, including coordinating materials, data outputs and presentation, agenda and minutes
• Work closely with the Clinical Development (Medical) Lead and external vendors or CROs to support signal detection activities, which may include preparing signal assessment and tracking documents, preparing action and communication plans to mitigate/manage product risks, and responding to safety related regulator requests
• Lead the development and maintenance of Reference Safety Information (RSI)
• Contribute to the development and review of clinical, regulatory and scientific documents including Investigator Brochures (IB), clinical study protocols, informed consent forms, clinical study reports, manuscripts/journal articles, scientific abstracts/posters, case report forms, statistical analysis plans and/or other documents as needed
• Project lead for DSURs or other aggregate safety report preparation
• Maintain knowledge of disease indication for assigned products
• Provide oversight of CROs and safety service providers, including ensuring compliance with contracts, deliverables, timelines, and regulatory expectations.
• Develop or support development of standard operating procedures (SOPs) and/or other process related documents.
• Support and contribute to inspection readiness, audits and compliance oversight activities
• Represent Safety at internal (e.g. cross-functional study and program teams) and external meetings (e.g. regulatory authority), ensuring integration of safety considerations into overall development plans.
• Help shape the growth of the safety function, including evaluating tools, technologies, and vendors to support future scalability.
• Contribute to team hiring, mentoring, and onboarding as the department expands.
• Serve as a backup for safety operations responsibilities, including case processing oversight, SAE reconciliation, and compliance metrics, when needed.
• Be a “player-coach,” willing to dive into both strategic discussions and tactical execution.

The Ideal Candidate will have:

• Advanced clinical degree (e.g., MD, DO, NP, PA,  in a health-related field) required. Candidates must have formal training and experience in patient care and clinical decision-making.
• Minimum of 8 years of experience in drug safety/pharmacovigilance, with at least 4+ years in safety science roles in clinical development.
• Experience in a biotech or small-to-mid-size pharma environment strongly preferred.
• 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 Thorough understanding of the drug development process and context applicable to safety surveillance activities
• Deep knowledge of global safety regulations, ICH guidelines, and pharmacovigilance practices.
• Ability to critically evaluate clinical and safety data, with sound clinical judgment and risk assessment skills.
• Excellent written and verbal communication skills; able to distill complex safety concepts into clear deliverables for diverse audiences.
• Strong interpersonal skills that facilitate collaboration across functions to reach consensus on safety topics.
• Experience with safety databases (e.g., Argus, VeevaSafety), data visualization tools (Spotfire, etc), or safety analytics platforms.
• Experience with MedDRA coding, Points to Consider, AoSE and SMQs
• Prior involvement in NDA/BLA/MAA submissions or interactions with global regulatory agencies preferred
• Familiarity with preclinical safety or translational safety.
• Demonstrated ability to mentor and lead others or contribute to team development, openness to future people leadership opportunities depending on business needs.

Who Will Love This Job:

• Individuals who prioritize delivering transformational therapies to patients, embracing urgency, and celebrating the journey toward excellence in advancing human health
• Comfort with ambiguity and evolving responsibilities; thrives in a collaborative, “roll-up-your-sleeves” environment and sees this as an opportunity for growth and development.
• Those who cultivate a culture of generous teaching and eager learning.
• Professionals who value collective achievement, trust, and accountability, acting as dedicated owners committed to success, while seeking diverse perspectives through candid, productive debate.

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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.