Medical Director, Safety Risk Management
United Therapeutics Corporation
August 09, 2026
Remote friendly (Raleigh-Durham-Chapel Hill Area)
United States
Medical Affairs
Responsibilities:
- Provide pharmacovigilance, regulatory, and medical expertise for assigned UT product(s)/program(s across the lifecycle.
- Support safety and pharmacovigilance deliverables to meet regulatory obligations and enable clinical development (e.g., ICSR medical review, aggregate reports/line listing, RSI [dCSI/CCSI & IB], NDA/BLA/IDE/PMA support, dRMP/RMP, REMS, safety variations, routine/ad-hoc signal detection, regulatory questions).
- Update Benefits: Risk (B:R) Assessment and documentation; review blinded clinical trial data.
- Perform medical review/assessment of ICSRs for product assignment (including spot checking CRO review for consistency and trend/signal identification).
- Review/document safety findings; analyze data listings to identify trends/signals.
- Write HHE for quality issues and/or patient impact.
- Support FMEA and MDR determination for drug-device combinations/standalone devices.
- Lead safety discussions with DMC/DSMB; review study protocols and safety-impacting documents (CIBs, ICFs, IB, COR docs).
- Collaborate with investigators/medical monitors on emerging safety issues and mitigation measures.
- Lead and write safety responses to regulatory authority requests.
- Support MARC/ISS/PAP/EAP activities; lead/plan observational studies using safety data.
- Train/educate CRO and other teams on product safety risks; act as medical expert as needed.
Minimum Requirements:
- MD.
- 5+ years patient safety (clinical/medicinal product) experience.
- 5+ years clinical practice experience.
- 3+ years international pharmaceutical industry experience (clinical research, drug safety, medical affairs, medical monitoring).
- Ability to analyze data to draw medical conclusions.
- Excellent oral/written communication for Health Authority responses & HHE.
- Strong interpersonal/time management; independent problem-solving; flexibility; ability to build cross-functional relationships; self-starter.
Preferred Qualifications:
- 5+ years industry experience in R&D, leading clinical studies, or as PI.
- 2+ years matrix team experience.
- 5+ years ICSR medical review/interpretation.
- MD with state physician licensure.
- Ability to influence stakeholders and reach consensus.
Job Location/Work Setup:
- Durham, NC office; hybrid (3 days in office; option 2 days/week remote). Travel up to 10%; relocation assistance may be available.
- Provide pharmacovigilance, regulatory, and medical expertise for assigned UT product(s)/program(s across the lifecycle.
- Support safety and pharmacovigilance deliverables to meet regulatory obligations and enable clinical development (e.g., ICSR medical review, aggregate reports/line listing, RSI [dCSI/CCSI & IB], NDA/BLA/IDE/PMA support, dRMP/RMP, REMS, safety variations, routine/ad-hoc signal detection, regulatory questions).
- Update Benefits: Risk (B:R) Assessment and documentation; review blinded clinical trial data.
- Perform medical review/assessment of ICSRs for product assignment (including spot checking CRO review for consistency and trend/signal identification).
- Review/document safety findings; analyze data listings to identify trends/signals.
- Write HHE for quality issues and/or patient impact.
- Support FMEA and MDR determination for drug-device combinations/standalone devices.
- Lead safety discussions with DMC/DSMB; review study protocols and safety-impacting documents (CIBs, ICFs, IB, COR docs).
- Collaborate with investigators/medical monitors on emerging safety issues and mitigation measures.
- Lead and write safety responses to regulatory authority requests.
- Support MARC/ISS/PAP/EAP activities; lead/plan observational studies using safety data.
- Train/educate CRO and other teams on product safety risks; act as medical expert as needed.
Minimum Requirements:
- MD.
- 5+ years patient safety (clinical/medicinal product) experience.
- 5+ years clinical practice experience.
- 3+ years international pharmaceutical industry experience (clinical research, drug safety, medical affairs, medical monitoring).
- Ability to analyze data to draw medical conclusions.
- Excellent oral/written communication for Health Authority responses & HHE.
- Strong interpersonal/time management; independent problem-solving; flexibility; ability to build cross-functional relationships; self-starter.
Preferred Qualifications:
- 5+ years industry experience in R&D, leading clinical studies, or as PI.
- 2+ years matrix team experience.
- 5+ years ICSR medical review/interpretation.
- MD with state physician licensure.
- Ability to influence stakeholders and reach consensus.
Job Location/Work Setup:
- Durham, NC office; hybrid (3 days in office; option 2 days/week remote). Travel up to 10%; relocation assistance may be available.