Medical Director, Safety Risk Management

California, US residents click here.

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
 

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
 

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.


Who You Are

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