Johnson & Johnson Careers

Global Medical Affairs Leader, Hepatitis B

Raritan, New Jersey; Beerse, Belgium
Medical Affairs


Job Description

Requisition ID: 00001F40

The Global Medical Affairs Leader (GMAL) Hepatitis B will be responsible for leading the clinical optimization for the product development and life cycle management strategies and plans for multiple products. S/he will partner closely with the GMA Operations Leader, Regional Medical TA/product leaders and Clinical Development Leaders to develop an integrated global medical affairs perspectives, strategies and plans.

 

The GMAL will be an integral member of the late stage development Compound Development Teams and a member of the DAS core team (Disease Area Stronghold). In addition, s/he will participate on the Global Commercial Team and as an ad hoc member of the clinical team. The GMAL will also be a core member of the Safety Management Team. The GMAL will be responsible for the development of the global medical affairs plan that reflects prioritized regional needs, which are included in the overall Compound Development Plan. In addition, the GMAL will be accountable for the leading the global publication plans, global opinion leader relations, global medical education (including symposia, speaker training) and global advisory boards through launch of major life cycle management initiatives.  The GMAL partners closely with the Market Access lead to co-develop an integrated evidence generation plan for the therapeutic area and the assets in development. The GMAL will also be responsible for facilitating and ensuring a consistent approach to Medical Affairs programs/activities globally.

 
Key Responsiblities
 
  • Develop global medical affairs strategy and plan for the compound based on prioritized regional needs.
  • Partner closely with the Vice President of Global Medical Affairs and other GMAF Leaders to ensure one franchise strategy.
  • Work with the CDTs to ensure integration with the overall global compound strategy, resulting in one global R&D and Medical Affairs compound development plan, inclusive of developing a Target Product Profile representing medical affairs global and regional value needs.
  • Provide single Medical Affairs voice into the creation of compound development and DAS strategies, plans and trial design for assets in development  from phase IIa through phase IV.
 
  • Be responsible for medical activities of new indications including Therapeutic Area global advisory boards, medical symposia and congress activities, in collaboration with functional leads of regional activity in these areas.
  • The Global Medical Affairs Medical Leader will be an active member of the core product CDTs and will lead a global Medical Affairs Team consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one medical affairs perspective and one "unified" voice on the CDT. They will collaborate closely with the regional medical affairs representatives to develop integrated global medical affairs strategies and plans and maintain open, two-way communication to ensure regional medical affairs is up to date on all plans, progress and decisions.
  • Synchronize input and output of the Med Affairs plan with the strategic and business plan calendars.
  • Lead global publications planning process oversight (with vendor support) including manuscripts, abstracts, posters and papers as well as pre-launch global KOL communications & speaker development. Review of manuscripts to ensure alignment with strategy and effective communication/presentation in internal and external audiences (e.g. Symposia).
  • The GMAL will co create integrated evidence generation strategy with Market Access,  and will be responsible for review and approval of all proposed evidence generation activities within Medical Affairs for Hepatitis .
  • Responsible to ensure all global activities following J&J Compliance principles, e.g. Health Care Compliance, etc.


Qualifications
  • A minimum of a Ph.D. or PharmD is required
  • An MD or a DO is preferred.
  • Experience in the infectious diseases, hepatology or gastroenterology therapeutic area is required
  • Prior experience in a Global or Regional Medical Affairs role is preferred
  • A minimum of 5 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required
  • A demonstrated track record leading highly matrixed, cross-functional work teams or similar experience comprised of high-level managers and executives is preferred
  • Proven ability to partner cross culturally/regionally is preferred 
  • In-depth knowledge of clinical methodology, clinical data reviews and analysis is preferred. Knowledge and experience in epidemiological studies and real world evidence is a plus  
  • Excellent knowledge  of study execution, benefit risk management and life-cycle management are preferred
  • Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues is required
  • Experience in developing and managing strategic relationships with medical experts/opinion leaders and other stakeholders (patients, advocacy groups)  is required. 
  • This position will be located in Raritan, NJ or Beerse, BE  and will require up to 30% domestic and international travel.

Primary Location
United States-New Jersey-Raritan-
Other Locations
Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization
Janssen Global Services, LLC (6085)
Job Function
Medical Affairs
Requisition ID
00001F40