Associate Scientific Director/Scientific Director, Medical Strategy

United Therapeutics•Rtp, NC

15h•Hybrid

About The Position

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 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

Requirements

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 (for Associate Scientific Director)
10+ 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 (for Scientific Director)
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%

Nice To Haves

2+ years of oncology experience
2+ years of pulmonary experience

Responsibilities

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 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