Medical Director, Safety Risk Management

California, US residentsclick 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
• 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.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

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

United Therapeutics  Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.