Executive Director, Global Safety Strategy & Benefit Risk Management

Executive Director, Global Safety Strategy & Benefit-Risk Management (Global Patient Safety)

Responsibilities

• Establish and execute enterprise safety strategy for investigational and marketed products across the pulmonary portfolio throughout the product lifecycle.
• Oversee Brand Safety Leads/Medical Safety Physicians; ensure scientifically robust safety surveillance, signal evaluation, regulatory compliance, and benefit-risk management across pulmonary devices, biologics, combination products, and innovative development programs.
• Develop and execute global safety strategy; establish scientific frameworks for benefit-risk assessment, safety surveillance, and risk minimization.
• Lead benefit-risk oversight for regulatory submissions, lifecycle management, safety governance committees, and health authority interactions.
• Provide scientific leadership for signal detection/evaluation, aggregate safety assessments, literature surveillance, epidemiology, and safety science; guide complex medical evaluations.
• Oversee development of safety strategies supporting RMP, REMS, PASS, PAES, and post-authorization safety commitments.
• Execute governance frameworks for consistent safety decision-making; provide oversight for safety review committees (e.g., PSMT, PSRC, MARC, PLRC, DMC) and drive inspection readiness.
• Lead pharmacovigilance strategy supporting global submissions, inspections, approvals, and lifecycle management; interpret evolving FDA/EMA/MHRA/PMDA/Health Canada requirements.
• Provide strategic leadership to Brand Safety organization; mentor physicians and safety leaders.
• Lead responses to complex regulatory inspections and significant safety findings; oversee CAPAs; ensure compliance with global pharmacovigilance regulations, ICH, and GVP.
• Drive innovation in pharmacovigilance (AI, analytics, automation).

Minimum Requirements

• MD
• 10+ years leading Safety Risk Management in pharma/biopharma
• 3+ years managing other MDs or sub-investigators
• 5+ years clinical trial support (PI/sub-I/development team)
• 3+ years matrix-team experience
• Proficient MS Office (Word/Excel/Outlook/PowerPoint); data analytics (e.g., Spotfire/QlikView)
• Evidence-based literature search and synthesis
• Excellent oral/written communication with Health Authorities; strong interpersonal/time management
• Ability to influence stakeholders, solve problems, and work proactively

Preferred Qualifications

• MD Pulmonology specialty (USA practice) and Board Certification
• 3+ years US clinical/medical practice and/or full US medical licensing
• State licensure

Travel/Location

Hybrid (RTP, NC) or remote in continental US; travel up to 15%.

Benefits

• Eligibility for company comprehensive benefits (medical/dental/vision/prescription, wellness, 401k/ESPP, PTO/paid parental leave, disability).

Compensation

Salary range: $275,000–$375,000/year.

Other

Participate in medical conferences; other duties as assigned.