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Role Description

The Head of Drug Safety will serve as the strategic and operational leader for the company’s pharmacovigilance function. This role combines medical oversight and PV scientist responsibilities with strong team leadership, ensuring robust safety surveillance for marketed products and clinical programs. The ideal candidate is an MD with deep expertise in pharmacovigilance and drug safety, capable of managing both hands-on activities and team leadership in a small, fast-paced biotech environment.

Key Responsibilities

• Leadership
  • Lead and mentor a small team of PV professionals (scientist and operational roles).
  • Foster a culture of compliance, scientific rigor, and continuous improvement.
  • Reporting to the Chief Medical Officer, contribute as a key member of the MedCORE and Genetix Leadership Teams.
• Medical Oversight
  • Serve as the Medical Director for all marketed and investigational products.
  • Perform medical review and assessment of adverse event reports, including seriousness, causality, and expectedness.
  • Author and approve aggregate safety reports (e.g., DSURs, PBRERs, SMP/RMP updates).
  • Provide medical input into signal detection, risk evaluation, and mitigation strategies.
  • Act as the primary medical contact for regulatory authorities on safety matters.
• PV Operations & Compliance
  • Oversee case processing activities, including timely submission of ICSRs to regulatory authorities (FAERS, EudraVigilance).
  • Ensure compliance with global PV regulations (FDA, EMA, ICH, MHRA).
  • Lead signal detection and management processes, including periodic safety reviews and safety committees.
  • Maintain and update PV SOPs, policies, and governance frameworks.
  • Manage vendor relationships for PV services and ensure quality oversight.
• Cross-Functional Leadership
  • Collaborate with Clinical Development, Regulatory Science, Quality, and Medical Affairs to ensure integrated safety strategies.
  • Provide PV input into clinical trial protocols, informed consent forms, and investigator brochures.
  • Support labeling updates and safety sections of regulatory submissions (IND, BLA, variations).

Qualifications

• MD degree required; clinical experience in a relevant specialty (e.g., hematology, oncology, cell and gene therapy) preferred.
• 10+ years of pharmacovigilance experience, including leadership roles.
• Proven experience with post-marketing PV and clinical trial safety; experience in hemoglobinopathies or cell and gene therapy preferred.
• Strong knowledge of global PV regulations (FDA, EMA, ICH); experience with interaction with regulatory authorities on safety matters preferred.
• Proficiency in using electronic safety databases (i.e., Argus).
• Excellent analytical, communication, and decision-making skills.
• Ability to thrive in a small biotech environment, balancing strategic and hands-on responsibilities.

Requirements

• Base Salary Range: $326,485 - $403,382.
• This role is eligible for an annual bonus and long-term incentive.
• Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.

Benefits

• Comprehensive health, life and disability insurance.
• Employer-matched 401(k) plan.
• Lifestyle spending account.
• Flexible time-off + paid holidays and winter shutdown.
• Tuition reimbursement & loan repayment assistance.
• Paid parental leave.
• Generous commuter subsidy.
• And much more.

Company Description

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.