Director, Drug Safety

This is a fully remote position, open to applicants in Washington.

📋 Description

• Take charge of the global drug safety and pharmacovigilance strategy for two development programs, ensuring alignment of safety initiatives with clinical, regulatory, CMC milestones, and commercial planning.

• Direct signal detection, evaluation, safety surveillance, and risk management efforts.

• Create clear benefit-risk assessments and implement suitable risk mitigation strategies.

• Act as the safety lead during interactions with health authorities, including FDA meetings and other regulatory engagements.

• Prepare safety briefing materials, responses, and related documentation.

• Lead or assist in the development of dossiers for marketing authorizations, including ISS development, safety narratives, labeling, and submission-level safety content.

• Supervise aggregate safety reporting, such as DSURs, PSURs/PBRERs, and other periodic safety reports.

• Manage safety case assessments, reconciliation, and regulatory reporting across relevant health authorities.

• Support DSMB activities and provide safety insights for protocols, investigator brochures, clinical study reports, and additional clinical and regulatory documents.

• Represent Drug Safety on cross-functional program teams and governance forums.

• Convert complex safety data and emerging risks into clear, actionable recommendations for program leadership and executive management.

• Offer Drug Safety leadership to facilitate commercial planning and launch activities.

• Establish and maintain core safety infrastructure, processes, vendor oversight standards, and SOPs in compliance with applicable regulations and ICH guidelines.

• Function as a hands-on leader within a streamlined, cross-functional organization; no direct reports at the time of hiring, with potential to expand the function over time.

⛳️ Requirements

• 8+ years of experience in biopharmaceutical drug safety and/or pharmacovigilance, including roles in safety leadership.

• A degree in a life science or related field is preferred (e.g., PharmD, MD, BSN or similar).

• Experience in oncology and/or neurology, neurodegenerative, or rare disease development.

• Proven experience in leading or supporting safety strategies through late-stage clinical development and programs that enable registration.

• Background in supporting or leading safety-related regulatory interactions, including the creation of briefing materials, responses, and other regulatory content.

• Strong understanding of global pharmacovigilance requirements, such as FAERS, EudraVigilance, and relevant ICH E2 guidelines.

• Familiarity with MedDRA and WHO Drug dictionaries.

• Experience with safety databases and signal detection tools, such as Argus or ArisGlobal.

• Experience in supporting health authority inspections and pharmacovigilance audits.

• Exceptional scientific writing, communication, and presentation skills, with the capability to distill complex safety data into clear recommendations for both technical and executive audiences.

• Proven ability to influence cross-functional teams, achieve alignment among diverse stakeholders, and drive decision-making without direct authority.

• Experience working independently in a lean biotechnology environment, balancing scientific, safety, regulatory, operational, and benefit-risk aspects.

• Preferred: demonstrated ownership of safety strategy for a US marketing application (NDA or BLA) or significant US/EU regulatory submission.

• Preferred: strong scientific judgment and the ability to formulate and adapt safety strategies when precedents are limited, evolving, or subject to interpretation.

• Preferred: experience with expedited development programs, such as Fast Track, Breakthrough Therapy, orphan drug designation, accelerated approval, or PRIME.

• Preferred: experience in designing and implementing REMS or other risk minimization programs.

• Preferred: comfort with emerging technologies and innovative methods to enhance safety surveillance, data review, and operational efficiency while maintaining scientific and regulatory integrity.

🏝️ Benefits

• Comprehensive medical, dental, and vision coverage: Leona covers 100% of employee premiums and 80% of dependent premiums (Premera Blue Cross PPO, Delta Dental, VSP).

• 401(k) with employer match: immediate eligibility, with Leona matching 100% of employee contributions up to 4% of salary.

• Generous paid time off: 25 days accrued annually, plus 11 paid holidays and a company-wide closure during the last week of December.

• Basic Life, AD&D, Short-Term and Long-Term Disability fully covered by Leona, with optional voluntary options available.

• Flexible Spending Accounts: options for Health and Dependent Care FSAs.

• Professional development: reimbursement of up to $6,000 annually for job-relevant, manager-approved education.

• Eligibility for annual bonuses.

• Equity eligibility.

• Complete benefits package.