Global Medical Affairs Director- Oncology

Location
Cambridge, MA, United States
Posted
Dec 06, 2018
Ref
R-01274
Hotbed
Genetown
Required Education
Associate Degree
Position Type
Full time
Title:
Global Medical Affairs Director- Oncology

Company:
Ipsen Bioscience, Inc.

Job Description:

Purpose of the position

Support the Global Brand Plan, product development and lifecycle management, in driving late-stage projects and global trials, coordinating local ones and providing medical guidance and expertise across organization and externally, on a specified scope of products/projects.

Responsibilities

Drive and/or coordinate post-approval studies in close cooperation with Clinical operations & the USA team
  • Ensure GCPs, Ethics and medical compliance are applied within all programs, set-up and coordinate appropriate monitoring processes, in coordination with regions
  • Participate and contribute to the Brand Strategy definition in close cooperation with the Marketing
  • Provide / integrate Medical insights within the Project Team
  • Ensure liaison and coordination with Servier Medical Affairs
    • Ensure common guidance for CSS and ISS
    • Participate and contribute to JDC and publication teams with Servier
  • Coordinate and follow-up local, in close cooperation with the USA medical team :
    • Define guidelines for local medical functions to design local clinical trials
    • Provide medical expertise to Medical Affairs Review Board on affiliate proposals
    • Provide support for centers selection
    • Approve protocol synopsis and objectives
    • Follow-up and support until completion


Provide medical expertise, guidance and support in the global articulation the medical strategy
  • Build and drive implementation of medical affairs action plan for his scope, within the 5-years Brand Plan
  • Support Medical Head in TPP definition and review
  • Prepare and drive medical activities to support launch of new products / new indications
  • Review medical enquiries for his/her scope upon request
  • Contributes tothe medical / product plan in providing insights on medical opportunities for further data generation in post-approval developments, label extension ...
  • Provide medical expertise to Market Research, Market Access activities (HEOR...)
  • Actualize his personal expertise through relations with internal / external medical experts
  • Ensure due diligence for products opportunities within Business Development activities


Provide guidance and content for medical training on assigned products & projects
  • Track and dispatch relevant publications in cooperation with Scientific information
  • Participate in training needs assessment and training plan guidelines definition - for his scope of products/projects
  • Create and/or validate product training content: medical educational materials, disease / product training packs, FAQs ...
  • Follow-up and support local training functions in the set-up of programs implemented by local / regional medical team


Develop relationships with scientific societies and collaborative groups to support Ipsen external visibility
  • Prepare and/or carry-on interventions in symposia / seminars or other external / internal events
  • Suggest participation in key medical events at global and local levels
  • Identify key collaborative groups or scientific societies to associate in line with GMA strategy, in cooperation with countries / regions and TAs in Development, and set-up action plans
  • Develop strong and sustainable relationships with KOLs, in line with the global KOL management plan.

Experience / Qualifications
  • MD or PhD with 5-10 years of industry experience
  • Oncology experience
  • International experience, Medical Affairs experience


IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.