Executive Medical Director, MD - Cardio Renal
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Location: Whippany, New Jersey, 07981, United States
Job ID: 51513202
Position Title: Executive Medical Director, MD - Cardio Renal
Company Name: Bayer
The Executive Director Medical Affairs develops Medical Affairs strategy, directs and participates in the planning and administration of activities concerned with the clinical evaluation of drugs in development for the purpose of obtaining an approved IND or NDA, post-marketing activities of currently approved and/or marketed products, and new clinical indications of existing drugs. Provide strategic direction and advice within the field of medical expertise and specialization to cross-functional teams and Global Medical Affairs teams. Actively manage the individual drug projects or portfolio of projects, which are assigned. Actively manage direct reports and teams.
Provide strategic direction and oversight with active participation and effective interaction with Global teams to ensure appropriate US and Global direction of the company's research and marketing efforts relative to the US environment as well as responsible for the design, planning and execution of an overall medical strategy including creating, organizing and leading Advisory Boards.
Provide strategic guidance, support and medical expertise to US and Global cross-functional teams within the Business Unit regarding development of educational materials, monitoring of published literature, addressing and resolving international, regional and local issues related to products under their responsibility and provide input to company documents to ensure scientific accuracy as well as implement the Medical Affairs Brand Plan, communication and publication programs with approved budgets
Support completion of annual NDA reports for respective brands through evaluation of clinical data and literature and provide USMA input in the preparation of key medical documents for INDs and NDAs.
This includes ensuring appropriate USMA input in interactions with the FDA, or global HAs and providing appropriate medical leadership for any interactions.
Chairs the scientific review meetings of investigator initiated and Phase IV studies and be answerable medically for the clinical studies under their direction as well as directing the design, conduct, analysis and reporting of Phase IV US clinical trials. This also includes providing key strategic US input for clinical development plans (Phase I - IV) and reviewing and co-approving clinical study protocols.
Participate in the Grant Review and Advisory Committees
Explore and evaluate new product ideas to assist in identifying new marketing opportunities and perform medical evaluations and due diligence on pharmaceutical products for in-licensing in the US
Interface with both internal and external (KOLs, advisors, consultants) experts and medical organizations in order to develop and maintain productive contacts
Provide feedback with the respective line manager in the recruitment, development and performance management of appropriate team members (including cross-functional partners) as well as managing performance and development planning of all direct reports including adhesion to all training and compliance policies.
Other financial magnitudes:
The position will be responsible for managing medical programs and projects related to product(s) within a given portfolio and therapeutic area with a medical budget of up to $15 million.
Qualification & Competencies:
M.D. Degree or equivalent, with US Board certification and licensure (active) highly preferred. Specialization in nephrology is required.
5+ years of clinically relevant or independent research experience or equivalent OR 5+ years' experience in the pharmaceutical or related industry or of extensive collaboration with the industry
(eg, lead PI and consultant, FDA employee or advisor)
Proven ability to lead, develop, communicate and execute strategic direction and vision
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 including contractors and consultants as well as performing successfully under stringent timelines and with competing priorities.
Proven ability to achieve timely approval of dossiers and regulatory submissions and to be able to develop highly successful clinical strategies and program
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