VP US Medical Affairs MD - Specialty Medicine
Employment Type: Full-Time
The primary purpose of this position is to lead the Therapeutic Area Medical Affairs (TA MA) group in General Medicine, including Cardiopulmonary, Hematology and Neurology, and to be responsible for the medical strategy and accountable for providing expertise for the General Medicine Business Unit in order to ensure the successful development and commercialization, and maximize the value to patients of products within the BUs.YOUR TASKS AND RESPONSIBILITIESThe primary responsibilities of this role, VP US Medical Affairs MD - Specialty Medicine, are to: Leads the medical strategy for Phase IV studies to support the commercial success of products;This includes: Directs the design, conduct, analysis and reporting of Bayer-sponsored US Phase IV clinical trials; Supervises the review, approval and conduct of US investigator led Phase IV studies for products and Ensures that all Phase IV studies are consistent with the approved global medical Phase IV strategy;Provides medical leadership oversight to Clinical Communications, Scientific Affairs, and HEOR staff (US based), strategies and tactical plans to influence the medical community regarding products and ensures the timely publication of study results;Represents Bayer Medical Affairs to key opinion leaders, medical organizations and media with respect to products;Collaborates with co-promotion/co-development partners on the medical input on safety issues and LCM strategy;Provides medical oversight to the review and approval of advertising and labeling copy to ensure its medical accuracy and compliance with ethical standards;Responsible for performing medical evaluations and due diligence on products for regional in-licensing;Responsible for providing US medical input for FDA interactions. This includes the following: Leads the preparation of key medical summary documents for US INDs, NDAs and sNDAs on products; Leads the medical interaction with FDA on issues relating to INDs and NDAs (e.g. directs the preparation of briefing documents/presentations) for products and Leads the preparation of the medical sections of Bayer’s US IND and NDA annual reports for compounds;Provides key strategic input on the global clinical development plans (Phase I-III) for general medicine and diagnostic imaging compounds;Responsible for the recruitment, development and performance management of US Medical Science Physicians, who participate on US and global clinical teams to conduct studies on compounds, with the goal of achieving timely product registration for new indications and commercial success. This includes the following: Assigns and supervises US Medical Science Physicians in their role as medical experts on Bayer sponsored clinical trials of compounds (Phases II-IV), and Directs the US Medical Science Physicians to perform medical reviews on clinical trials of compounds (Phases II-IV) conducted in the US Manages and directs the review and approval of educational grant requests and CME programs;Responsible for the recruitment, development and performance management of US Medical Science Liaison team, including MSLs and MSL management,in the Cardiopulmonary, Hematology, and Neurology TAs.WHO YOU AREYour success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:Required Qualifications:Education: M.D. Degree, with clinical research experience as well as Board certification/eligibility;Experience:Candidate should have at least 8-10 years directly related pharmaceutical industry experience involving clinical development (including experience with IND and NDA submissions) and/or Medical Affairs experience. (exceptional academic medical experience may be substituted for up to 50% of this requirement);Incumbent must have demonstrated originality in problem solving as applied to drug development and have skills and experience in dealing with government officials in the U.S. and abroad;The incumbent must have had significant successful interactions with key opinion leaders;Competencies:Deep Disease/Therapeutic knowledge and understanding of drug development process;Experience of using clinical trial methodology and technology;Highly effective communicator with strong written and oral communication skills;Experience of developing and delivering presentations and publications in English and local language;Experience of managing departmental budgets;Experience of strategic planning and project management;Understanding of global regulations and guidelines;Experience of regularly interacting with regulatory agencies;Experience of effectively managing risk and compliance issues;Line management experience;Experience of managing teams across cultures and geographies;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;Proven ability to achieve timely approval of dossiers and regulatory submissions;Strong negotiation and influencing skills;Proven leadership abilities and a successful track record of directing clinical teams in a global matrix environment;Highly developed ethics and integrity, with demonstrated ethical medical decision making skills;Proven ability to identify and resolve complex problems;Proven ability to perform successfully under stringent timelines and with competing priorities.Country: United StatesState: New JerseyLocation: WhippanyReference Code: 65337Functional Area:Medical Affairs & PharmacovigilanceEntry Level : Job Starter
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