[Hiring] Senior Medical Director @Bayer

Role Description

The Senior Medical Director, Menopause, 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.

YOUR TASKS AND 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.
• Plan, lead and execute advisory meetings to gather feedback on relevant questions 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

Qualifications

• 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.

Requirements

• 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 (e.g., lead PI and consultant, FDA employee or advisor).

Benefits

• Employees can expect to be paid a salary of between $248,000 to $372,000.
• Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.