J&J Family of Companies Senior Global Medical Affair Leader, Maternal Fetal Medicine & Benign Hematology (Sr GMAL, MFM/BH) in Cambridge, Massachusetts
As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.
Janssen is looking for a Senior Global Medical Affair Leader, Maternal Fetal Medicine & Benign Hematology (Sr GMAL, MFM/BH). This role can be located in Horsham, PA or Cambridge, Massachusetts.
The Sr GMAL, Maternal Fetal Medicine &Benign Hematology (Sr GMAL MFM/BH) is responsible for leading the clinical-commercial optimization of product development and life cycle management strategies and plans for the assigned marketed compounds and compounds in clinical development within the Immunology TA. The Sr GMAL MFM/BH will report directly to the VP, Global Medical Affairs (GMA) , Immunology. He/she will lead the MFM & Benign Hematology group within Immunology Global Medical Affairs and will manage the GMAL(s) and Director, Global Patient Advocacy within the group. Sr GMAL MFM/BH will represent GMA on the assigned Disease Areas Stronghold (DAS) and/or Pathway Areas Strongholds(PAS). The Sr GMAL MFM/BH and/or direct reports will lead Global Medical Affairs Teams (GMATs) and partner closely with Regional Medical TA/product leaders to develop integrated global medical affairs perspectives, strategies and plans. The Sr GMAL MFM/BH and/or direct reports will be a member of one or more Compound Development Teams (CDTs), Safety Management Teams, Global Commercial Teams and Global Market Access Teams and will be responsible for development of the global medical affairs plan that reflects prioritized regional needs and which are included in the overall Compound Development Plan. In addition, his/her group will be accountable for the global publications plans, global opinion leader relations, global medical education (including symposia, speaker training) and global advisory boards for products starting in early development (phase IIA) and through launch of major life cycle management initiatives (earlier or later as needed).
Lead the GMA Maternal Fetal Medicine & Benign Hematology group in Immunology GMA, managing 1 or more GMALs (directors or senior directors) and Dir, Global Patient Advocacy within the group
Sr GMAL MFM & Benign Hematology and his/her team will:
Develop GMA strategy and plan for the assigned compounds based on prioritized regional needs. Work with the CDT 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.
Lead patient advocacy initiatives and strategy in applicable autoantibody diseases by driving, building and enhancing strategic alliances with key national and international stakeholders, including patient advocacy groups, physician advocacy groups, academic organizations and other relevant stakeholders in response to patient needs and in support of Janssen’s global patient advocacy objectives and related strategic goals responsibility for Janssen’s patient advocacy landscape assessment and engagement strategy.
- Lead/participate in the GMAT(s), consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one medical affairs perspective and one “unified” voice on the CDT.
- Provide single Medical Affairs voice into the creation of compound development and LCM strategies, plans and trial design from phase IIa through phase IV.
- Lead pre-launch medical activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, coordination of regional activity in these areas.
- 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.
Lead development and execution of the global publication plan as well as review and approval of publications and scientific congress displays for marketed products and specified compounds in clinical development
- Manage the ReCAP process (review of all medical affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for applicable products.
- Support development of the company risk management strategy and plan as well as author and review specific sections of the Periodic benefit-risk assessment report for compounds. Perform Medical impact assessments as required.
A minimum of a Ph.D or MD degree (or equivalent) is required
A minimum of 10 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required
At least five years in the Medical Affairs environment is highly desirable.
A demonstrated track record of success within Medical Affairs and/or clinical R&D is required
A demonstrated track record leading highly matrixed, cross-functional work teams comprised of high-level managers and executives is required.
Proven ability to act as a medical spokesperson for external audiences is required
Strong experience developing and managing strategic relationships with medical experts/opinion leaders is required
Experience in disease area and an established network with medical experts/opinion leaders in maternal fetal medicine or hematology is highly preferred
Experience in rare disease area is highly preferred
Experience in patient advocacy and engagement is highly desirable
Proven track record on ethics and Credo principles
Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues within the TA.
Excellent knowledge of study execution, benefit risk management and regulatory affairs
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-Horsham-800/850 Ridgeview Drive
Janssen Global Services, LLC (6085)
J&J Family of Companies
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