US Medical Affairs Director for Women's Health Leadership Role

4 days ago


Charleston, West Virginia, United States Lifelancer Full time

Unlock Your Potential as a Medical Affairs Director at Lifelancer

About the Opportunity

We are seeking an exceptional Medical Affairs Director to lead our US operations in Women's Healthcare. As a key member of our team, you will play a vital role in shaping our medical strategy and driving business growth.

Job Summary

The Medical Affairs Director will be responsible for directing and participating 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, post-marketing activities of currently approved and/or marketed products, and new clinical indications of existing drugs.

Key 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
  • 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 educational materials, monitoring of published literature, addressing and resolving international, regional, and local issues related to products under their responsibility
  • 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
Requirements
  • M.D. Degree or equivalent required
  • Clinically relevant or independent research experience or equivalent experience in the pharmaceutical or related industry or of extensive collaboration with 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 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
What We Offer

We offer a highly competitive salary range of $208,835 to $313,252, depending on your qualifications and experience. Additionally, you can expect a comprehensive benefits package, including health care, vision, dental, retirement, PTO, and sick leave.



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