Executive Director, Global Safety Strategy & Benefit Risk Management

Scorpion Therapeutics; Chapel Hill (NC); Hybrid; USD 275,000 - 375,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

401k/ESPP

PTO/paid parental leave

Disability insurance

Job summary

Scorpion Therapeutics seeks an Executive Director, Global Safety Strategy & Benefit-Risk Management to lead global pharmacovigilance across pulmonary products throughout development and lifecycle, ensuring robust safety surveillance and regulatory readiness.

The role directs governance, mentors medical safety leaders, and drives strategic safety initiatives including RMP/REMS, post-authorization commitments, and health authority interactions, with hybrid work in RTP, NC or remote in continental

Qualifications

• MD with evidence of leadership in Safety Risk Management.
• 10+ years leading Safety Risk Management in pharma/biopharma.
• 3+ years managing MDs or sub-investigators.
• 5+ years clinical trial support (PI/sub-I).
• Excellent oral and written communication with Health Authorities.
• Ability to influence stakeholders and solve problems.

Responsibilities

• Establish and execute enterprise safety strategy across portfolio.
• Oversee safety surveillance, signal evaluation, and risk minimization.
• Lead governance for safety decision-making and inspections.
• Direct pharmacovigilance strategy for submissions and lifecycle.
• Mentor safety leaders and manage cross-functional teams.

Skills

Leadership

Regulatory communication

Stakeholder influence

Data analytics

Project management

Education

MD

US medical license

Tools

Spotfire

QlikView

Job description

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.