Quality Recruiting. Established Experts.

Head of Medical Affairs

Reference Number: 3038
Location: NJ

Our client is a rapidly growing, specialty pharmaceutical company.  They have asked us to assist them in their search for a Head of Medical Affairs.

Major tasks and responsibilities will include:

  • Provides medical/clinical expertise to internal (marketing, manufacturing, managed care, regulatory affairs, R&D, and legal) and external (healthcare professionals, patients, advocacy groups, etc.) customers.
  • Works with key stakeholders to develop and execute the medical affairs plan for existing products and compounds in development (as necessary) in the US. Key aspects of this plan will include:  Publications, educational grants of interest (IME), guideline strategy, and life cycle management (IST/Phase III/IV studies).
  • Leads/Supports US launch-readiness activities for compounds in development.
  • Leads US Medical Science Liaison (MSL) program. Develops goals, targeting and tools and manages the performance and compliance of MSL team.
  • Supports Sales team with therapy area and drug related training and educational updates, as well as ad hoc representative support where specific medical/scientific input is needed.
  • Supports business development, potential product evaluation and due diligence.
  • Develops and manages budgets required to implement US Medical Affairs plans, and regularly reports progress to stakeholders.
  • Responsible for the US Medical Information Service. Ensures a compliant and effective Medical Information request and response system is in place. Drafts and maintains responses to medical information inquiries.
  • Fosters and facilitates Investigator Sponsored Trial submissions/review and execution/reporting of approved projects.
  • Develops and manages clinical advisors.  Assists in the selection of outside experts and maintains key relationships of mutual interest around clinical trials, guidelines and advisory boards.
  • Identifies relevant medical meetings and congresses; determines appropriate participation (Med Affairs station, abstracts, posters, etc.).
  • Develops and delivers scientific and medical presentations, organizes and leads medical advisory boards, participates in investigator meetings, provides medical support to commercial advisory boards.
  • Represents Medical Affairs on US Leadership Team, Brand Teams, Project Teams and LCM Teams to provide insight on products, patient treatment trends, scientific activities as well as report on status of Med Affairs initiatives.
  • Represents Medical Affairs on Legal, Medical, Regulatory Review Committee. Reviews/approves advertising and promotional, as well as scientific and educational materials.
  • Supports speaker bureau by assisting commercial team with identifying educational needs, content development, speaker identification, training and ongoing evaluation.
  • Provides clinical support to Managed Markets team.
  • Conforms to company policies and US guidelines on medical affairs including: IME, publications, Investigator sponsored trials, interaction with internal sales/marketing and interactions with health care professionals.
  • Works with the drug development function as needed on US based clinical trials (i.e., identifying investigators and supporting ongoing studies through investigator and site contact).
  • Must be familiar with the US drug safety process and assist in the follow up and evaluation of specific US drug safety issues, when needed.

We seek candidates with the following qualifications:

  • Doctorate Degree (PharmD, MD, or PhD) required.
  • At least 10 years of experience working within medical affairs.
  • A solid background in scientific and clinical methodology with knowledge of oncology or orphan diseases, pharmacology and therapeutics.
  • Oncology or orphan disease experience strongly preferred.
  • Prior experience hiring and leading teams.
  • Excellent verbal and written communication skills with internal and external customers.
  • Strong presentations and teaching skills.
  • Ability to work independently and strategically.
  • Capability to accept and initiate change in a dynamic environment.
  • Experience of working in matrix organizations and providing informal or direct leadership.
  • Eager to learn and develop personal skills; takes the initiative in staying abreast of scientific and industry advances in the relevant therapy areas.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3038. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.