Medical Director, Safety Risk Management
United Therapeutics Corporation
June 27, 2026
Remote friendly (Raleigh-Durham-Chapel Hill Area)
United States
Medical Affairs
Who You Are
Medical Director, Safety Risk Management provides pharmacovigilance, regulatory, and medical expertise for assigned United Therapeutics product(s)/program(s) across lifecycle; supports safety/pharmacovigilance deliverables to ensure favorable benefit-risk balance and business operations.
Responsibilities
- Medically/clinically support drug safety/pharmacovigilance deliverables (e.g., ICSR medical review, aggregate reports/line listing, RSI (dCSI/CCSI & IB), NDA/BLA/IDE/PMA submission, dRMP/RMP, REMS, safety variations, routine/ad-hoc signal detection, regulatory questions)
- Update Benefits:Risk (B:R) Assessment; review blinded clinical trial data
- Perform ICSR medical review/assessment for product assignment; spot-check CRO medics for consistency/trends
- Review/document safety findings; analyze listings to identify safety trends/signals
- Write HHE for quality issues/patient impact; support FMEA and MDR determination (drug-device combination or device)
- Lead safety discussions with DMC/DSMB; review/input study protocols and safety-impact documents (CIBs, ICFs, IB, COR)
- Collaborate with investigators and medical monitors on emerging safety issues and mitigation
- Lead/write regulatory authority safety responses; support MARC/ISS/PAP/EAP activities
- Lead/plan observational studies using safety data; train CRO/teams; serve as medical expert as needed
Minimum Requirements
- MD
- 5+ years patient safety experience; 5+ years clinical practice; 3+ years international pharma industry experience (clinical research, drug safety, medical affairs, medical monitoring)
- Data analysis ability; strong oral/written communication; interpersonal/time management
- Independent, reasoned problem-solving; flexibility; cross-functional relationship building; self-starter
Preferred Qualifications
- 5+ years pharma/R&D/clinical studies or PI experience; 2+ years matrix experience; 5+ years ICSR review/interpretation
- MD with state physician licensure
- Ability to influence stakeholders and meet regulatory/safety/business objectives
Benefits (if eligible)
- Medical/dental/vision/prescription; wellness resources; 401k/ESPP; paid time off and paid parental leave; disability benefits.
Job Location
- Durham, NC (hybrid: 3 days in office; 2 days/week remote); travel up to 10%; relocation assistance may be available.
Medical Director, Safety Risk Management provides pharmacovigilance, regulatory, and medical expertise for assigned United Therapeutics product(s)/program(s) across lifecycle; supports safety/pharmacovigilance deliverables to ensure favorable benefit-risk balance and business operations.
Responsibilities
- Medically/clinically support drug safety/pharmacovigilance deliverables (e.g., ICSR medical review, aggregate reports/line listing, RSI (dCSI/CCSI & IB), NDA/BLA/IDE/PMA submission, dRMP/RMP, REMS, safety variations, routine/ad-hoc signal detection, regulatory questions)
- Update Benefits:Risk (B:R) Assessment; review blinded clinical trial data
- Perform ICSR medical review/assessment for product assignment; spot-check CRO medics for consistency/trends
- Review/document safety findings; analyze listings to identify safety trends/signals
- Write HHE for quality issues/patient impact; support FMEA and MDR determination (drug-device combination or device)
- Lead safety discussions with DMC/DSMB; review/input study protocols and safety-impact documents (CIBs, ICFs, IB, COR)
- Collaborate with investigators and medical monitors on emerging safety issues and mitigation
- Lead/write regulatory authority safety responses; support MARC/ISS/PAP/EAP activities
- Lead/plan observational studies using safety data; train CRO/teams; serve as medical expert as needed
Minimum Requirements
- MD
- 5+ years patient safety experience; 5+ years clinical practice; 3+ years international pharma industry experience (clinical research, drug safety, medical affairs, medical monitoring)
- Data analysis ability; strong oral/written communication; interpersonal/time management
- Independent, reasoned problem-solving; flexibility; cross-functional relationship building; self-starter
Preferred Qualifications
- 5+ years pharma/R&D/clinical studies or PI experience; 2+ years matrix experience; 5+ years ICSR review/interpretation
- MD with state physician licensure
- Ability to influence stakeholders and meet regulatory/safety/business objectives
Benefits (if eligible)
- Medical/dental/vision/prescription; wellness resources; 401k/ESPP; paid time off and paid parental leave; disability benefits.
Job Location
- Durham, NC (hybrid: 3 days in office; 2 days/week remote); travel up to 10%; relocation assistance may be available.