Senior Medical Strategy Manager; Remote

Remote

RTP, NC

Remote- US

Full time

R05317

California, US residents  () .

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

You are a strategic Medical Affairs professional who combines scientific expertise with operational excellence to drive evidence generation and advance patient care. You thrive in cross-functional environments, leading investigator-sponsored and strategic studies, building trusted relationships with investigators and KOLs, and translating complex data into meaningful insights that shape medical strategy and support innovative therapies.

The Senior Medical Strategy Manager will 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). Additionally, 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

Minimum 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…