California, US residentsclick here.

The job details are as follows:

The Medical Director, Safety Risk Management role will provide pharmacovigilance, regulatory and medical expertise for assigned United Therapeutics (UT) product(s)/program(s) across lifecycle. This role will support all safety and pharmacovigilance responsibilities to ensure favorable benefit-risk balance and business operations.

The Medical Director will contribute clinically and medically to teams, supporting signal detection, aggregate reports, labeling, risk management, and clinical R&D, and lead and drive medical safety strategy in collaboration with other product/program leads & teams for PASS or PAES and Observational Studies. Additionally, they will be responsible for supporting and defending Pharmacovigilance & medical safety position across product lifecycle.

• Medically and clinically support all drug safety/pharmacovigilance deliverables required to satisfy regulatory obligations and support clinical development strategies with quality deliverable & timeliness. This includes, but is not limited to, ICSR medical review, aggregate reports/line listing, RSI (dCSI/CCSI & IB), NDA/BLA/IDE/PMA submission, dRMP/RMP, REMS, safety variation, routine and ad-hoc signal detection, regulatory questions etc.
• Provide updates to Benefits: Risk (B:R) Assessment and supporting documentation, including review of blinded data from clinical trials
• Perform medical review/assessment of ICSR for product assignment, including spot checking of medical review performed by CRO medics for consistency and trend/signal identification
• Review and document safety findings, and analyze data listings, to identify safety trends or signals for assigned product/program
• Write HHE for quality issues or patient impact assessment
• Support development of FMEA and MDR determination for drug device combination or standalone device
• Lead safety discussions in collaboration with other product or program leads with DMC/DSMB
• Review and provide input to the study protocol, CIBs, ICFs, IB, and COR development documents impacting patient safety for trials or programs
• Collaborate with study investigator to clarify and gather further understanding of potentially emerging safety issues/trends or potential safety concerns with specific queries or discussions
• Collaborate with medical monitors to develop safety mitigation measures for enrolled patients
• Lead and write safety responses to regulatory authority requests
• Support MARC, ISS, PAP, and EAP program activities across UT and its partners for assigned product(s)
• Lead, plan, and support observational studies using safety data in alignment with overall UTC goals
• Remain current on other business deliverables to ensure business and procedural compliance
• Train and educate CRO and other teams on assigned product(s) and communicate/educate core safety risks for the product of their responsibilities
• As required, serve as medical expert for other business activities
• Perform other duties as assigned

Minimum Requirements

• MD
• 5+ years of professional experience with patient safety at the clinical or medicinal product level
• 5+ years of clinical practice experience
• 3+ years of relevant, international pharmaceutical industry experience (i.e., clinical research, drug safety, medical affairs, medical monitoring)
• Ability to analyze data to draw medical conclusions
• Excellent oral and written communication skills to support responses to Health Authority requests & HHE
• Excellent interpersonal and time management skills, to ensure compliance with firm timelines
• Ability to think outside of the box and present independent, reasoned solutions to identified safety issues & minimizing risk to patients within the program or commercial therapy
• Demonstrated problem solving skills that enact change and drive continuous improvement
• Ability to be flexible, adaptable, and open minded in a constantly changing environment
• Ability to build and manage cross-functional relationships by motivating and inspiring others
• Self-starter with ability to work under minimal direction

Preferred Qualifications

• 5+ years of industry experience with pharmaceutical activities such as R&D, leading clinical studies, or serving as principal investigator (PI)
• 2+ years of experience working in a matrix team environment, including supporting other team members when required
• 5+ years of experience with medical review and interpretation of ICSRs
• MD - Physician - State Licensure
• Ability to influence stakeholders, reach consensus, and meet critical regulatory, safety & business objectives

Job Location

This position will be located at our Durham, NC office with a hybrid schedule of 3 days in office and the option to work 2 days each week from home. In office requirements could change based on business needs. This position may travel up to 10%. Relocation assistance may be available for non-local candidates.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities