Job Details

Supervise the review, approval and conduct of U.S. investigator-led Phase IV studies for products and ensure that all Phase IV studies are consistent with the approved global medical Phase IV strategy
Provide medical leadership oversight to Clinical Communications, Scientific Affairs and the U.S.-based Data Generation and Observational Studies staff, strategies and tactical plans to influence the medical community regarding products and ensures the timely publication of study results
Represent Bayer Medical Affairs to key opinion leaders, medical organizations and media with respect to products
Collaborate with copromotion/co-development partners on the medical input on safety issues and LCM strategy
Provide medical oversight to the review and approval of advertising and labeling copy to ensure its medical accuracy and compliance with ethical standards
Be responsible for performing medical evaluations and due diligence on products for regional in-licensing
Be responsible for providing U.S. medical input for FDA interactions
Lead the preparation of key medical summary documents for U.S. INDs, NDAs and sNDAs on products
Lead the medical interaction with FDA on issues relating to INDs and NDAs (e.g. directs the preparation of briefing documents/presentations) for products
Provide key strategic input on the global clinical development plans (Phase I-III) for general medicine and diagnostic imaging compounds
Be responsible for the recruitment, development and performance management of U.S. Medical Science Physicians, who participate on U.S. and global clinical teams to conduct studies on compounds, with the goal of achieving timely product registration for new indications and commercial success
Direct the U.S. Medical Science Physicians to perform medical reviews on clinical trials of compounds (Phases II-IV) conducted in the U.S.
Manage and direct the review and approval of educational grant requests and CME programs
Be responsible for the recruitment, development and performance management of U.S. Medical Science Liaison team, including MSLs and MSL management, in the TAs.

• M.D. or equivalent, with U.S. Board certification and licensure (active)
• At least five years of clinically relevant or independent research experience or equivalent or at least five years of experience in the pharmaceutical or related industry or of extensive collaboration with the industry (e.g. lead PI and consultant, FDA employee or advisor)
• Proven ability to identify and resolve complex problems
• A solid understanding of clinical study design, analysis and interpretation as well as the principles of observational studies and health economics
• Ability to collaborate with a variety of teams and personnel as well as a proven ability to interact effectively with key opinion leaders
• Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills
• Ability to work well on teams as well as ability to assume leadership of a team
• Strong negotiation and influencing skills
• Proven ability to implement successful clinical strategies and programs
• Effective communicator with strong oral and written communications skills
• Demonstrated success in leading both internal and cross functional project teams
• Advanced medical knowledge in nephrology
• Understanding of global regulations and guidelines
• Experience of participating in cross-functional teams
• Experience of working across and building effective working relationships between functions
• Proven ability to interact with and influence key opinion leaders, as well as medical organizations
• Strong negotiation and influencing skills.

Reference ID - GH/JC//02072020//91464/VP US Medical Affairs MD Cardiovascular and Renal Medicine