Director Medical Affairs WHC, Menopause

About This Role

Direct and participate in the planning and administration of activities concerned with the clinical evaluation of drugs in development for women's health care, particularly menopause. Provide medical expertise to cross-functional teams and actively manage individual drug projects.

Responsibilities

• Participate and interact with Global teams to ensure US direction for research and marketing efforts
• Design, plan, and execute overall medical strategy, including organizing and leading Advisory Boards
• Provide medical expertise to US cross-functional teams within the Business Unit regarding educational materials and literature monitoring
• Address and resolve international, regional, and local issues related to products under responsibility
• Implement the Medical Affairs Brand Plan, communication, and publication programs with approved budgets
• Support completion of annual NDA reports through evaluation of clinical data and literature
• Provide USMA input for INDs and NDAs, including interactions with the FDA
• Chair scientific review meetings of investigator-initiated and Phase IV studies
• Direct the design, conduct, analysis, and reporting of Phase IV US clinical trials
• Provide strategic US input for clinical development plans (Phase I – IV) and review/co-approve clinical study protocols

Requirements

• M.D. Degree or equivalent (DO or MBBS)
• Clinically relevant or independent research experience or equivalent OR experience in the pharmaceutical or related industry or extensive collaboration within the industry (e.g., 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
• 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
• Proven ability to achieve timely approval of dossiers and regulatory submissions

Qualifications

• M.D. Degree or equivalent (DO or MBBS)
• 5+ years of clinically relevant or independent research experience or equivalent OR 5+ years’ experience in the pharmaceutical or related industry or extensive collaboration with the industry

Nice to Have

• US Board certification and licensure (active)
• 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

Benefits