Role Description
The Director Medical Affairs MD, Legacy Therapeutics will direct and participate in the planning and administration of activities concerned with the clinical evaluation of legacy products for the purpose of advising on post-marketing activities and maintenance of therapies. Provide advice within the field of medical expertise and specialization to cross-functional teams. Actively manage legacy therapy projects.
Your Tasks and Responsibilities
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Active participation and effective interaction with Global teams to ensure appropriate US direction of the companyβs research and marketing efforts relative to the US environment.
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Responsible for the design, planning, and execution of an overall medical strategy including creating, organizing, and leading Advisory Boards.
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Provide support and medical expertise to US cross-functional teams regarding development of materials, monitoring of published literature, and addressing and resolving international, regional, and local issues related to products.
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Provide input to company documents to ensure scientific accuracy as well as communication and publication programs.
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Support evaluation of clinical data and literature and provide USMA input in the preparation of key medical documents for external communication (e.g., regulatory agencies).
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Ensure appropriate USMA input in interactions with the FDA and provide appropriate medical leadership for any interactions.
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Providing key strategic US input and reviewing and co-approving clinical study protocols.
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Participate in Advisory Committees.
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Interface with both internal and external (KOLs, advisors, consultants) experts and medical organizations to develop and maintain productive contacts.
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Provide feedback with the respective line manager in the recruitment, development, and performance management of appropriate team members.
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Manage performance and development planning of all direct reports including adherence to all training and compliance policies.
Qualifications
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M.D. Degree or equivalent (DO or MBBS).
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Clinically relevant or independent research experience or equivalent experience in the pharmaceutical or related industry.
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Proven ability to identify and resolve complex problems.
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A solid understanding of clinical study design, analysis, and interpretation as well as the principles of observational studies and health economics.
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Ability to collaborate with a variety of teams and personnel.
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Proven ability to interact effectively with key opinion leaders.
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Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills.
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Ability to work well on teams as well as assume leadership of a team.
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Strong negotiation and influencing skills.
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Proven ability to implement successful clinical strategies and programs.
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Effective communicator with strong oral and written communications skills.
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Demonstrated success in leading both internal and cross-functional project teams.
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Proven ability to achieve timely approval of dossiers and regulatory submissions.
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Ability to develop highly successful clinical strategies and programs.
Requirements
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US Board certification and licensure (active) highly preferred.
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8+ years of relevant experience.
Benefits
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Salary range: $180,400 to $292,000.
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Additional compensation may include a bonus or commission.
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Health care, vision, dental, retirement, PTO, sick leave, etc.
Company Description
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s).
Bayer is an Equal Opportunity Employer/Disabled/Veterans.
Bayer is an E-Verify Employer.