Director Medical Affairs, Legacy Therapeutics

Bayer•Tulsa, OK

7h•Remote

About The Position

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. This role provides advice within the field of medical expertise and specialization to cross-functional teams and actively manages legacy therapy projects.

Requirements

M.D. Degree or equivalent (DO or MBBS).
Clinically relevant or independent research experience or equivalent 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 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 programs.

Nice To Haves

US Board certification and licensure (active) highly preferred.
8+ years of relevant experience.

Responsibilities

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 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 communication and publication programs.
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).
Ensure appropriate USMA input in interactions with the FDA and providing appropriate medical leadership for any interactions.
Providing key strategic US input and reviewing and co-approving clinical study protocols.
Participate Advisory Committees.
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.