Director, Medical Affairs

US-NJ-Princeton
Category
Medical Affairs
Type
Regular Full-Time

Position Summary

Reporting to the Vice President, Medical Affairs and Pharmacovigilance, the Director, Medical Affairs is responsible for providing medical support to the Company’s product development strategy and post marketing commitments, while supporting Medical Affairs strategy related to the Investigator Sponsored Trials (IST) program. This individual will interface with physicians, clinical investigators, regulatory agencies and internal departments.  The Director, Medical Affairs must possess an in depth knowledge of oncology products, agents in the pipeline, and all associated disease areas. This position will provide leadership within Medical Affairs and may represent the department at key internal and external meetings.  This position will include providing input on marketing programs and representing the company at scientific, clinical and business development meetings.

Responsibilities

  • Responsible for direct management of projects and project associated personnel.
  • Responsible for the development of an IST working plan for appropriate products or therapeutic areas.
  • Responsible for providing medical input into development, execution and interpretation of Phase I, II, III and IV clinical protocols. This includes review of draft IST protocols, reports and manuscripts.
  • Oversee clinical registries and evaluate safety issues associated with products and promotional activities for the company’s products in accordance with respected regulatory requirements.
  • Assist in critically evaluating study results in statistical and final reports and ongoing reviews with study investigators, resolving problems arising in the course of clinical investigations and preparing reports to the management and medical community.
  • Responsible for direct interaction with investigators, KOLs and the research community to support company initiatives.
  • Responsible for representing the company at scientific, clinical and business development meetings.
  • Direct medical writing activities associated with Medical Affairs to ensure accurate execution of product dossiers, product related slide decks, standard response letters, FAQs as well as corporate abstracts, posters, oral presentation and manuscripts when appropriate.
  • Promote effective communication between internal and external groups regarding Medical Affairs initiatives.
  • Act as a key member of the GMAC, PRC and MRC.
  • Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources.
  • Interact in collaborations with strategic partners.

Qualifications

Educational Requirements:  

  • Must be a Physician (MD)
  • Board Certified in Oncology, preferred but not required.

 

Experience:

  • 10+ years experience in pharmaceutical or biotech industries.
  • 5 years Medical Affairs experience required, with a minimum of 5 years of comprehensive oncology experience.
  • Intellectual strength, analytical ability and high professional standards in designing, conducting and evaluating clinical research.
  • 5+ years as a medical monitor on company sponsored trials is preferred.
  • Clinical trial and publication experience essential.
  • Knowledgeable and current in GCP guidelines in US and ROW.
  • Outstanding leadership, team, presentation, written and oral skills required.
  • Collaborative and flexible in personal interactions at all levels of the company.
  • Ability to work proactively and effectively, with exceptional creative problem solving skills.
  • 30-50% travel requirement and may include weekends.

 

Other Skills and Abilities:

  • Operational knowledge of outlook, MS Word, Power Point and Excel are required.

 

Language Skills:

  • Ability to read, analyze and interpret scientific and technical information and data.
  • Excellent English communication skills, both verbal and written and presentation skills.

 

Physical Demands:

  • While performing the duties of this job, the employee is frequently required to sit and stand.
  • The employee is occasionally required to walk.
  • There may be occasional domestic and international travel includes spending time at cancer trial sites/institutions, conference centers, offices and hotels.

 

 Work Environment:

  • The noise level in the office work environment is usually quiet.

 

 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

The incumbent in this position may be required to perform other duties, as assigned.

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