Medical Director, Safety Risk Management

United Therapeutics•Rtp, NC

8d•Hybrid

About The Position

United Therapeutics (UT) is seeking a Medical Director, Safety Risk Management to provide pharmacovigilance, regulatory, and medical expertise for assigned products/programs throughout their lifecycle. This role is crucial for ensuring favorable benefit-risk balance and supporting business operations by overseeing all safety and pharmacovigilance responsibilities. The Medical Director will contribute clinically and medically to various teams, supporting signal detection, aggregate reports, labeling, risk management, and clinical R&D. They will lead and drive medical safety strategy for post-authorization safety studies (PASS) or post-authorization epidemiological studies (PAES) and observational studies in collaboration with other product/program leads and teams. Additionally, this role is responsible for supporting and defending the company's pharmacovigilance and medical safety positions across the product lifecycle. The Medical Director will provide medically and clinically sound support for all drug safety/pharmacovigilance deliverables required to meet regulatory obligations and support clinical development strategies with quality and timeliness. This includes, but is not limited to, ICSR medical review, aggregate reports/line listings, RSI (dCSI/CCSI & IB), NDA/BLA/IDE/PMA submissions, dRMP/RMP, REMS, safety variations, routine and ad-hoc signal detection, and responding to regulatory questions. The role also involves providing updates to Benefit:Risk (B:R) Assessments and supporting documentation, including reviewing blinded data from clinical trials. The Medical Director will perform medical reviews/assessments of ICSRs for product assignment, including spot-checking medical reviews performed by CRO medics for consistency and trend/signal identification. They will review and document safety findings, analyze data listings to identify safety trends or signals, and write Health Hazard Evaluations (HHE) for quality issues or patient impact assessments. The position supports the development of Failure Mode and Effects Analysis (FMEA) and Medical Device Reporting (MDR) determinations for drug-device combinations or standalone devices. The Medical Director will lead safety discussions with Data Monitoring Committees (DMCs)/Data Safety Monitoring Boards (DSMBs) in collaboration with other product or program leads. They will review and provide input to study protocols, Investigator Brochures (IBs), Informed Consent Forms (ICFs), and Clinical Outcome Reports (COR) development documents that impact patient safety for trials or programs. Collaboration with study investigators is key to clarify and gather further understanding of potentially emerging safety issues/trends or potential safety concerns through specific queries or discussions. The role also involves collaborating with medical monitors to develop safety mitigation measures for enrolled patients and leading/writing safety responses to regulatory authority requests. The Medical Director will support Marketed Product, Investigator Sponsored Studies (ISS), Patient Assistance Programs (PAP), and Expanded Access Programs (EAP) activities across UT and its partners for assigned products. They will lead, plan, and support observational studies using safety data in alignment with overall UTC goals. The role requires staying current on other business deliverables to ensure business and procedural compliance, and training/educating CROs and other teams on assigned products, communicating/educating core safety risks. As required, the Medical Director will serve as a medical expert for other business activities and perform other duties as assigned.

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

Nice To Haves

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

Responsibilities

Provide pharmacovigilance, regulatory and medical expertise for assigned United Therapeutics (UT) product(s)/program(s) across lifecycle.
Support all safety and pharmacovigilance responsibilities to ensure favorable benefit-risk balance and business operations.
Contribute clinically and medically to teams, supporting signal detection, aggregate reports, labeling, risk management, and clinical R&D.
Lead and drive medical safety strategy in collaboration with other product/program leads & teams for PASS or PAES and Observational Studies.
Support and defend 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.
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.
Serve as medical expert for other business activities.
Perform other duties as assigned.