Medical Director – Clinical Development and Medical Affairs

LOCATION: Ardsley, NY

 

FULL DESCRIPTION:

The Medical Director – CDMA is responsible for providing oversight in the development and life cycle management for assigned products. This individual requires leadership skills necessary for the strategy, development, management and implementation of Phase II-IV studies for assigned products, both within approved indication(s) and as pilot studies for new indications. The Medical Director is extensively involved with development colleagues, regulatory affairs, and the commercial organization. This individual is responsible for ensuring seamless transition of products from early development to late stage research.

 

*Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Serves as medical team leader.
  • Attends scientific meetings and fosters and develops strong relationships with investigators.
  • Contributes to the development of new indications for existing products.
  • Assists with the development and implementation of publication strategies for products in development.
  • Identifies and implements high value strategies for product life cycle development.
  • Participates in multidisciplinary teams including alliance partners for strategic and tactical planning of in-line and products in development.
  • Acts as a team leader for study design, implementation and timely completion of assigned clinical studies and helps address post-marketing research needs.
  • Provides direction, training and follow-up to ensure compliance with department and corporate policies and procedures.
  • Manages aggressive timelines; integrate scientific rigor, medical need and commercial value into clinical plans culminating in successful registration and marketing.
  • Participates in strategic oversight and leadership for clinical development from proof of concept to NDA filing.

 

Supervisory Responsibilities:

  • The Medical Director leads assigned cross-functional teams.

 

Education and Experience:

  • M.D. is required.
  • Strong neuroscience background is required.
  • Board certification in Neurology is preferred.
  • A minimum of three to five years progressive experience in pharmaceutical, biopharmaceutical or biotechnology drug development is required.
  • Excellent understanding of the interdependencies of the various preclinical, clinical, regulatory and commercial disciplines is required.
  • Prior experience in managing clinical trial conduct for neurological disorders is required
  • Strong working knowledge of GCP, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies designated for review by regulatory authorities.
  • A proven ability to build productive relationships and teams both internally and externally and the ability to develop high potential subordinates into leadership roles is critical.
  • Ability to facilitate and merge strong science into commercially viable products.
  • Must be proficient in MS Office Suite.
  • Strong leadership and organizational skills.
  • Excellent oral and written communication skills.
  • Experience leading large projects/organizations.
  • Energetic, flexible, enthusiastic and highly motivated.
  • Able to work effectively with outside service providers.
  • Ability to maintain high level of ethical and compliancy standards.
  • Demonstrated ability to stay abreast of trends and new information in the profession
  • Highly effective teamwork and interpersonal skills and the ability to work across numerous scientific disciplines.

 

  • This position requires travel (including overnight stays); average travel for this position is 25-30% with some variation based upon the demands of business imperatives. Travel is both domestic and international for internal and external business meetings.