Senior Director, Safety Science (Biotech)

TL;DR

Senior Director, Safety Science (Biotech): Providing strategic safety science leadership across a clinical-stage portfolio with an accent on pharmacovigilance, signal detection, and benefit-risk evaluation. Focus on shaping safety capabilities, driving integrated safety governance, and leading regulatory interactions for protein-based medicines.

Location: Somerville, MA

Salary: $277,000 – $416,000 USD

Company

A clinical-stage generative biology company pioneering the AI revolution in drug design to create protein-based medicines.

What you will do

• Lead strategic safety science and integrated surveillance for assigned development programs, including signal detection and benefit-risk evaluation.
• Design and shape safety strategies for products transitioning from early to late-phase clinical development.
• Manage cross-functional safety governance and lead Safety Management Teams to ensure robust decision-making and risk escalation.
• Oversee the preparation of core safety deliverables such as DSURs, Investigator Brochures, and regulatory responses.
• Represent the safety function in high-level interactions with regulatory authorities and external partners.
• Build and optimize pharmacovigilance processes, SOPs, and digital tools to ensure scalability and inspection readiness.

Requirements

• MD, DO or equivalent with formal training in patient care and clinical decision-making.
• Minimum 12 years of experience in drug safety/pharmacovigilance within clinical development.
• At least 6 years of experience in safety science roles with strategic responsibility for clinical-stage assets.
• Deep knowledge of global pharmacovigilance regulations, ICH guidelines, and aggregate reporting requirements.
• Proven track record of supporting major regulatory milestones, preferably including NDA, BLA, or MAA activities.
• Experience overseeing CROs and external safety service providers.

Nice to have

• Experience in biologics, translational safety, or emerging therapeutic modalities.
• Familiarity with safety databases and analytics platforms like Argus, Veeva Safety, or Spotfire.

Culture & Benefits

• High-impact senior individual contributor role with broad autonomy and meaningful influence.
• Collaborative environment that values candid communication, expertise, and continuous learning.
• Competitive compensation package including annual bonus and equity.
• Opportunity to work at the intersection of machine learning and generative biology.