Global Medical Affairs Leader (GMAL), Director, Gastroenterology
- Horsham, PA
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Global Medical Affairs Leader (GMAL) Gastroenterology. The position will be located in Springhouse or Horsham, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Global Medical Affairs Leader (GMAL) Gastroenterology, under direction of the Senior GMAL Gastroenterology, 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. He/she will lead or be a key participant in the Global Medical Affairs Team (GMAT) and partner closely with Regional Medical TA/product leaders to develop integrated global medical affairs perspectives, strategies and plans. The GMAL will be a member of the Compound Development Teams, the Safety Management Teams and Global Commercial Teams as well as an ad hoc member of the Clinical Team and Global Market Access Team and will be responsible for development of the Global Medical Affairs (GMA) plan that reflects prioritized regional needs and which are included in the overall Compound Development Plan. In addition, the GMAL will be accountable for the global publication plans, global opinion leader relationships, and global advisory boards. The GMAL will also be responsible for facilitating and ensuring a consistent approach to Medical Affairs programs/activities globally. The GMAL will be responsible to ensure all global activities follow J&J Compliance principles, eg. Health Care Compliance, etc.
The GMAL will be responsible for but not limited to the following:
- 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.
- Provide single Medical Affairs voice into the creation of compound development and LCM strategies, plans and trial design from phase IIa through phase IV.
- Responsible for pre-launch medical activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, coordination of regional activity in these areas.
- The GMAL will be an active member of the CDT and will lead/participate in the GMAT, consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one Medical Affairs perspective and one unified voice on the CDT.
- 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.
- Responsible for the development and execution of the global publication plan as well as review and approval of publications and 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 Evaluation Report for compounds. Perform Medical Impact assessments as required.
- A minimum of a PhD or MD degree (or equivalent) is required with specialty training and certification in gastroenterology 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, with at least 3 years in the Medical Affairs environment is highly desirable.
- Extensive clinical and/or pharmaceutical experience in Immunology or gastroenterology is required.
- A demonstrated track record of success within Medical Affairs and/or clinical R&D is required.
- Proven ability to act as a medical spokesperson for external audiences is required with superior communication skills oral and written. Also required is strong experience developing and managing strategic relationships with medical experts/opinion leaders.
- In-depth knowledge of study methodology, study data reviews and analysis is highly preferred.
- Excellent knowledge of study execution, benefit risk management and regulatory affairs is highly preferred.
- An established network with medical experts/opinion leaders in inflammatory bowel disease is highly preferred.
- Knowledge of products, both J&J and competitors, in the Therapeutic Area is highly preferred.
- A proven track record on ethics and Credo principles.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Janssen Global Services, LLC (6085)
Back to top