Global Medical Affairs Leader, Maternal-Fetal Immunology

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Job Function: Medical Affairs Group

Job Sub Function: Medical Affairs

Job Category: Scientific/Technology

All Job Posting Locations: Horsham, Pennsylvania, United States of America

Job Description:

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We are searching for the best talent for Global Medical Affairs Leader (GMAL), Maternal-Fetal Immunology (MFI), in our Global Commercial Strategic Organization (GCSO) based in Horsham, PA.

Purpose:

The Global Medical Affairs Leader (GMAL), Maternal-Fetal Immunology (MFI) is a Director level individual contributor role responsible for leading the execution of medical affairs strategy for the clinical-commercial optimization of product development and life cycle management. GMAL will partner closely with several cross functional and cross regional stakeholders including the Regional Medical TA/product leaders, global commercial and market access leaders, Clinical Development Leaders, Compound Development Leaders, other R&D colleagues, GMA Operations Leader, etc., to develop integrated global medical affairs perspectives, strategies, and plans.

You will be responsible for:

1. Contribute to the development and lead the execution of the Global Medical Affairs (GMAF) strategy and plan for MFI based on prioritized global and regional needs.
2. Collaborate with the Compound Development Team(s) (CDT) to ensure MAF integration with the overall global compound strategy. Provide single Medical Affairs voice into the creation of compound development and LCM strategies, plans and trial design from phase IIa through phase IV.
3. MFI External Engagement: build and maintain relationships with key MFM specialists and adjunct HCP specialists, present MFI data and strategies to global KOLs through MAF core communication channels, and provide medical leadership with external stakeholders including professional and patient organizations, HA bodies, and the broader MFM community.
4. 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.
5. Lead development and execution of the MFI global publication plan, review and approval of publications and scientific congress presentations, lead ongoing updates to MFI Scientific Communications Platform, and initiation and co-leadership of Publication Steering Committees to prepare for and execute Phase 3 trial data dissemination.
6. Collaborate closely with Global Director of Advocacy and Engagement to build and maintain key strategic alliances with medical, patient, and academic organizations.
7. Develop Global Integrated Evidence Generation Plan (IEGP), including RWE strategy and objectives, ensuring alignment with overall GMAF and Brand strategy for MFI, coordinating with regional and cross-functional stakeholders to build and periodically update evidence catalogues.
8. Lead Global medical training on MFI indications, including development of novel training resources, ensuring pull-through of key concept and messages by regional and cross-functional stakeholders.
9. Co-lead the asset specific cross regional medical affairs strategic discussions (MAST) and cross regional knowledge transfer and scientific exchange meetings (WISE) for MFI.
10. Manage the ReCAP process (review of all medical affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for MFI studies.
11. Support routine safety reporting and collaborate with safety monitoring team (SMT).

Qualifications / Requirements:

1. An advanced scientific/medical degree (e.g. MD, PhD, PharmD) is required.
2. Experience in Maternal-Fetal Immunology, Rare Diseases or Autoantibody Diseases is highly preferred.
3. A minimum of 8-10 years of combined relevant experience in a medical/clinical/scientific function in the pharmaceutical industry is required.
4. Medical Affairs experience is highly preferred.
5. Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues is required.
6. Global mindset and ability to partner cross culturally/regionally is required.
7. In-depth knowledge of study/clinical methodology, study/clinical data reviews and analysis is preferred.
8. A demonstrated track record leading highly matrixed, cross-functional work teams comprised of high-level managers and executives is required.
9. Experience developing and managing strategic relationships with medical experts/opinion leaders is required.
10. Proven ability to act as a Scientific Matter Expert for external audiences is required.
11. Excellent knowledge of study execution, benefit risk management and life-cycle management are preferred.
12. Proven track record of ethical decision making is required.
13. Experience in patient advocacy and engagement is highly desirable.
14. A minimum of 20% travel, including global travel, is required.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.