Global Medical Director, Povetacicept

Role Summary

The Global Medical Affairs Strategy Medical Director will provide medical leadership for the Povetacicept programs, focusing on gMG with potential involvement in IgAN and pMN. Responsible for developing and executing the medical strategy and plans under the direction of the Global Medical Affairs Lead/Executive Director, and ensuring alignment with cross-functional teams and patient/community input.

Responsibilities

• Main focus will be on gMG Medical Affairs activities, but may contribute to activities for the kidney indications for pove (i.e., IgAN and pMN), as needed.
• Develops medical affairs plans, including Launch and Life Cycle Management plans
• Critically interprets scientific data, determines the potential impact of new research on clinical practice, and uses scientific and clinical data to formulate frameworks and disease management approaches
• Provides input from medical community into clinical development and commercial strategies
• Effectively communicates scientific data through presentations and publications
• Ensures country/regional insights and needs are considered in global medical strategies and activities
• Provides scientific input and expertise as a medical reviewer and supports the development of global medical, commercial, regulatory, and reimbursement documents
• Performs/oversees medical/scientific training for Medical, Commercial, and other internal stakeholders
• Reviews investigator-sponsored study (ISS) proposals and other research grants

Qualifications

• M.D. degree or equivalent (e.g., MBBS, D.O.)
• Strong immunology and/or neurology background preferred, as role will focus on gMG
• Requires at least 3 years of experience working in the biotech/pharma industry or the equivalent combination of education and experience. Experience working on asset(s) in highly competitive disease area(s) is a plus.
• Requires experience in a Medical Affairs function and in the analysis of research (pre-clinical or clinical) data and publications; working knowledge of biostatistics as well as scientific and clinical research methods, and clinical study design.

Skills

• Deep understanding of global medical, regulatory and commercial (including payer) environments
• Excellent understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with key external stakeholders (e.g., healthcare providers, payers, advocacy bodies)
• Deep understanding of market access in key countries
• Excellent written and oral communication skills to influence others internally/externally
• Ability to develop relationships in a highly matrixed environment, as well as external relationships with global, regional and local thought leaders and industry experts
• Ability to engage in positive dialogue and resolve conflicts in a constructive manner

Education

• M.D. degree or equivalent (e.g., MBBS, D.O.)
• Strong immunology and/or neurology background preferred, as role will focus on gMG
• Requires at least 3 years of experience in biotech/pharma industry or equivalent; experience with asset(s) in competitive disease areas is a plus
• Experience in Medical Affairs with analysis of research data and publications; knowledge of biostatistics and clinical study design