Associate Scientific Director/scientific Director, Medical Strategy

Associate Scientific Director/scientific Director, Medical Strategy Lead cross-functional medical strategy studies across multiple disease states to inform product development Location: North Carolina, United States Job Tags: Strategy & Ops About The Role Associate/Scientific Director, Medical Strategy 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 Associate/Scientific Director, Medical Strategy will manage and oversee day‑to‑day operational and scientific activities within medical affairs. Develop and oversee strategic initiatives within the post‑marketing space to address identified scientific gaps across product franchise. Ensure assigned Investigator Sponsored Studies (ISS) and data query programs are managed appropriately. Represent global medical affairs (GMA) interests and needs in multi‑disciplinary teams (e.g. commercial and development project teams, clinical study team meetings). Conduct and oversee small strategic studies and Phase IIIb/IV tactics led by GMA. Lead Medical Affairs strategic planning, driving, tracking, and coordinating data generation in a timely and compliant manner across UT franchise; cover multiple disease states and/or multiple products (e.g. PAH, PH‑ILD, IPF, PPF, oncology). Develop strong relationships with thought leaders and elicit involvement and feedback on key medical strategies. Communicate with investigators in the ISS program and foster timely execution of newly approved and ongoing studies; lead quarterly data reviews of new data generated from ISS program. Design, execute, and manage strategic studies by medical affairs. Provide operational oversight and manage external vendors/CRO for small strategic studies and non‑interventional, minimal risk studies conducted by Medical Affairs; provide input for clinical operations / product development operations, as needed. Design and implement tactics for phase IIIb/IV data generation. Lead and/or participate in cross‑functional teams to support products throughout their lifecycle (launch planning, medicine development plans, project team meetings, etc.). Identify data gaps across UT franchise; generate and present material for Medical Affairs field teams and Advisory Boards. Stay abreast of developments and gather information, and effectively communicate insight on Medical Affairs activities to leverage critical data and synthesize information for key stakeholders. Perform backup medical technical reviews of promotional materials, sales training materials, and other material for external use (e.g. advisory board content and non‑promotional reprints) by providing medical/scientific input, validation of data, and consistency and compliance with product package inserts, established guidelines, institutional laws, regulations and practices. Collaborate with external HCPs, KOLs, and CROs to author scientific publications that further UT's medical strategy. Minimum Requirements Associate Scientific Director, Medical Strategy Doctor of Philosophy (PhD), Doctor of Pharmacy (PharmD) or MD. 8+ years of pharmaceutical/biotech company experience in Medical Affairs or a post‑doc fellowship in Medical Affairs; alternative pharmaceutical experience may be taken into consideration. Record of accomplishment and increasing responsibility in scientific, clinical and/or pharmaceutical industry setting. Ability to initiate and lead projects. Solid working knowledge of word processing, spreadsheet, email and presentation software (MS Office suite). Excellent written and oral communication skills. Excellent team building skills. Ability to travel up to 25%. Preferred Qualifications 2+ years of oncology experience. 2+ years of pulmonary experience. Location This position will be located in the RTP, NC office of United Therapeutics. Currently this job is a hybrid role requiring at least three days per week in the office. In‑office requirements could increase based on business needs. #J-18808-Ljbffr