Director Medical Affairs WHC, Contraceptives

Overview

Director Medical Affairs WHC, Contraceptives

Director Medical Affairs Women’s Health Care (WHC), Contraceptives, will direct and participate 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 advice within the field of medical expertise and specialization to cross-functional teams.

Actively manage the individual drug projects which are assigned.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Director Medical Affairs WHC, Contraceptives, are to:

• Active participation and effective interaction with Global teams to ensure appropriate US 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 support and medical expertise to US 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 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 adherence to all training and compliance policies.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• M.D. Degree or equivalent (DO or MBBS) is required;
• Clinically relevant or independent research experience or equivalent OR experience in the pharmaceutical or related industry or extensive collaboration within the industry (eg, 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…