The Senior Global Medical Affairs Leader (Sr GMAL), Bermikimab, is responsible for leading the clinical-commercial optimization of product development and life cycle management strategies and plans for bermekimab and any other compounds within the Immunodermatology Disease Area Stronghold that are assigned by the Sr GMAL, Immunodermatology. He/she will lead the Global Medical Affairs Team and partner closely with Regional Medical TA/product leaders to develop integrated global Medical Affairs perspectives, strategies and plans. The Sr GMAL will be a member of the pertinent CompoundDevelopment Teams, the Safety Management Teams and Global Commercial Teams, as well as serve as an ad hoc member of the Clinical and Global Market Access Teams. He/she will be responsible for development of global Medical Affairs plans that reflect prioritized regional needs, which are included in the overall compound development plans. In addition, the GMAL will be accountable for global publication plans, global opinion leader relations, global medical education (including symposia, speaker training) and global advisory boards for bermekimab and any other assigned compounds through launch of major life cycle management initiatives (earlier or later as needed). The GMAL will also be responsible for facilitating and ensuring a consistent approach to Medical Affairs programs/activities globally.
Develop global Medical Affairs strategy and plans for bermekimab and any other assigned compounds based on prioritized regional needs; work with the CDT to ensure integration with the overall global compound strategies, resulting in a unified global R&D and Medical Affairs compound development plan; develop Target Product Profiles for key indications representing Medical Affairs global and regional value needs.
Provide a single Medical Affairs voice for the creation of compound development and LCM strategies, plans and trial designs from phase IIa through phase IV.
Assume responsibility for pre-launch medical activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, and coordination of regional activity in these areas.
Contribute as an active member of pertinent CDTs and lead a global Medical Affairs TA Team consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create an aligned Medical Affairs perspective and a “unified” voice on the CDTs.
Collaborate closely with regional Medical Affairs representatives to develop integrated global Medical Affairs strategies and plans and maintain open, two-way communication to ensure regional Medical Affairs teams are up to date on all plans, progress and decisions.
Synchronize input and output of the Medical Affairs plan with the strategic and business plan calendars
Assume responsibility for the development and execution of the global publication plans for bermekimab and any other assigned compounds, as well as review and approval of abstracts, posters and manuscripts.
Manage the ReCAP process (review of all Medical Affairs-sponsored clinical trials and Investigator-Initiated Sponsored studies) for bermekimab and any other assigned compounds.
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 bermekimab and any other assigned compound. Perform Medical impact assessments as required.
Assume responsibility for ensuring that all global activities follow J&J Compliance principles (e.g. Health Care Compliance).
- A minimum of an MD degree is required; specialty training and certification in Dermatology is preferred.
- Extensive clinical and/or pharmaceutical experience in Immunology or Dermatology is required. Experience in dermatology disease areas and an established network with medical experts/opinion leaders in dermatology (i.e., atopic dermatitis, hidradenitis suppurativa) is highly preferred
- 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 desireable.
- Knowledge of both J&J and competitor products in the Therapeutic Area is required.
- A demonstrated track record leading highly matrixed, cross-functional work teams comprised of high-level managers and executives is required.
- A demonstrated track record of success within Medical Affairs and/or clinical R&D is essential.
- A global mindset and direct experience in multiple markets, as well as a proven ability to partner cross-culturally/regionally is required.
- In-depth knowledge of study methodology, and study data reviews and analysis is essential.
- Excellent knowledge of study execution, benefit risk management and regulatory affairs
- A highly innovative mindset with the ability to drive a complex and changing environment, and effectively manage and resolve issues within the TA is required.
- Proven ability to act as a medical spokesperson for external audiences is required. Also required is strong experience developing and managing strategic relationships with medical experts/opinion leaders.
- A proven track record on ethics and Credo principles is required.
Janssen Global Services, LLC (6085)