Medical Director, Safety Risk Management

United Therapeutics Corporation•RTP, NC, NC

1d•Hybrid

About The Position

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

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.