Senior Medical Strategy Manager

United Therapeutics Corporation•RTP, NC, NC

12d•Hybrid

About The Position

United Therapeutics (Nasdaq: UTHR) is a publicly-traded biotech/pharmaceutical company with a public benefit purpose to provide a brighter future for patients through the development of novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. Founded in 1996, the company has six FDA-approved therapies for PAH, PH-ILD, and neuroblastoma. Their pipeline focuses on PAH and PF, and they are also developing manufactured organs to address the organ transplant shortage. The company is seeking a strategic Medical Affairs professional with scientific expertise and operational excellence to drive evidence generation and advance patient care. This role involves managing investigator-sponsored studies, leading cross-functional teams, and translating complex data into meaningful insights to shape medical strategy.

Requirements

Doctor of Philosophy (PhD), Doctor of Pharmacy (PharmD) or MD
5+ years of pharmaceutical/biotech company experience in Medical Affairs or a post-doc fellowship in Medical Affairs; Alternative pharma experience may be taken into consideration
Excellent written and oral communication skills
Excellent team building
Ability to initiate and lead projects
Record of accomplishment and increasing responsibility in scientific, clinical and/or pharmaceutical industry setting
Solid working knowledge of word processing, spreadsheet, email and presentation software (MS Office suite)
Ability to travel up to 35%

Responsibilities

Manage and oversee day-to-day operational and scientific activities within medical affairs and ensure assigned Investigator Sponsored Studies (ISS) and data query programs are managed appropriately.
Represent medical affairs interests and needs in multi-disciplinary teams (e.g. project teams, clinical study team meetings).
Conduct and oversee small strategic studies by medical affairs.
Oversee the ISS program in partnership with other Medical Affairs staff and provide scientific and operational support to enhance the ISS review, approval, documentation, and tracking processes.
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 small 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.
Prepare and present detailed tactics for phase IV data generation.
Collaborate with cross-functional teams to support products throughout their lifecycle (launch planning, medicine development plans, project team meetings, etc.).
Generate material for Medical Affairs field teams and Advisory Board.
Stay abreast of developments and gather information and insight on Medical Affairs activities to leverage critical data and synthesize information for key stakeholders.
Perform back up 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.