Clinical & Medical Affairs Manager

ROLE TYPE: Hybrid Working,
The Global Medical Affairs Director leads the medical strategy & tactics for a key program/indication, ensuring the US and International medical perspective is reflected.
They will develop, own and drive the execution of the Integrated Evidence Plan (IEP), ensuring the right evidence is available at the right time to enable access and clinical adoption of our assets.
They will also act as a strategic partner to Biomedical Research (BR), Development, International Medical Affairs, US Medical Affairs, Strategy & Growth and Commercial.
Development and execution of high quality medical strategy for the asset/ indication and vision throughout its lifecycle at global level.
Creation and execution of the integrated evidence plan addressing US and International top market needs and supporting clinical adoption of the asset, incl. various evidence generation vehicles, e.g. interventional trials, RWE, data mining, IITs etc.
Design, set-up and execution of interventional clinical trials
Serves as disease area medical expert for internal stakeholders from different line functions as well as external customers.
Partners with Development, Strategy and Growth (S&G), US and International cross-functions to diversify evidence to achieve broad access at launch and to enhance impact on clinical practice for the asset.
Financial tracking to ensure timely development & execution of medical activities.
Prepare Specification Review Committee (SRC) submissions for Therapeutic Area (TA) assets within remit.
Represent GMA around prioritized portfolio with internal and external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners.
Provide proactive input to asset lifecycle management on potential new therapeutic indications to consider.
Ensures GMA activities are designed and executed in compliance with company policy guidelines and highest medical quality standards.
MD or equivalent (preferred), PhD, or PharmD degree required
5+ years in Pharmaceutical Industry experience in Medical Affairs and/or Clinical Development
~ Successful development and execution of innovative medical strategies, a broad of range of medical tactics and Integrated Evidence Plans
~ Track record of successful high-quality evidence generation projects
~ Firm working knowledge in Good Clinical Practice (GCP), evidence generation activities, such as interventional or non-interventional studies and Real World Evidence (RWE) projects, including scientific communication of their results
~ Deep understanding of health care systems and key external stakeholders such as Health Care Professionals (HCPs), payers, medical societies and guideline committees
~ Understands unmet medical needs, generates the right evidence to effectively address them, uses innovative, multichannel communication formats for effective evidence dissemination
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