Senior Medical Director, Contraception, USMA

Bayer•Tulsa, OK

19h•Remote

About The Position

The Senior Medical Director, Contraception, USMA, WHC is responsible for developing and leading medical strategy for pre-commercial and marketed programs. The Senior Medical Director will lead the development of strategy and tactical execution of activities across the portfolio, while engaging and aligning with US and global cross-functional teams. Under the guidance of the TA VP, lead the development of strategy for marketed assets, the primary responsibilities of this role, Senior Medical Director, Contraception, USMA, WHC, are to: Lead the execution of associated tactical activities specifically related to all current and future LCM activities; 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; Participate as a medical and clinical expert in BD and L activities as appropriate; Review and evaluation of products relative to current standard of care and alternative treatments; 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; Plan, lead and execute advisory meetings to gather feedback on relevant question identified for assigned products; Active participation and effective interaction with global teams to ensure and support appropriate US direction of LCM strategy; Interface with both internal and external (KOLs, advisors, consultants) experts and medical organizations to develop and maintain productive contacts, develop collaborative research projects, and publish scientific papers with high clinical impact; Engage members of USMA WHC team to assist with completion of assigned responsibilities, as needed Contributes directly to the generation and disclosure of scientific and clinical data on pipeline and marketed products to appropriate health care stakeholders; Collaborate with internal and external partners/customers including: US and Global Cross-Functional Partners Key Opinion Leaders Clinical Trial Investigators Medical Affairs and Commercial Senior Management MSL’s and Field Senior Directors

Requirements

M.D. Degree or equivalent (DO or MBBS) is required
Previous experience in data generation, management, and publications
Clinically relevant or independent research experience or equivalent or experience in the pharmaceutical or related industry or of extensive collaboration with the industry (e.g., lead PI and consultant, FDA employee or advisor)
A solid understanding of clinical study design, analysis and interpretation as well as the principles of observational studies and health economics
Proven ability to identify and resolve complex problems
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 within 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
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)

Responsibilities

Lead the execution of associated tactical activities specifically related to all current and future LCM activities
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
Participate as a medical and clinical expert in BD and L activities as appropriate
Review and evaluation of products relative to current standard of care and alternative treatments
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
Plan, lead and execute advisory meetings to gather feedback on relevant question identified for assigned products
Active participation and effective interaction with global teams to ensure and support appropriate US direction of LCM strategy
Interface with both internal and external (KOLs, advisors, consultants) experts and medical organizations to develop and maintain productive contacts, develop collaborative research projects, and publish scientific papers with high clinical impact
Engage members of USMA WHC team to assist with completion of assigned responsibilities, as needed Contributes directly to the generation and disclosure of scientific and clinical data on pipeline and marketed products to appropriate health care stakeholders
Collaborate with internal and external partners/customers including: US and Global Cross-Functional Partners, Key Opinion Leaders, Clinical Trial Investigators, Medical Affairs and Commercial Senior Management, MSL’s and Field Senior Directors