Senior Global Medical Affairs Leader, Bladder Cancer

Responsibilities

• Lead the development of the Global Medical Affairs (GMAF) strategy and plan for the assigned compound(s) based on prioritized regional needs.
• Collaborate with the Compound Development Team(s) (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 W-MAST (formerly GMATs) 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- and post-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.
• Lead relevant patient advocacy initiatives and strategy 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.
• 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.
• Lead pre-approval access strategy for compound(s).

Job Qualifications

• An advanced scientific/medical degree (e.g. MD, PhD, PharmD, MPH or other masters level degree) is required.
• A M.D. or D.O. is preferred.
• Experience in bladder cancer 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 preferred.
• Having an established network with medical experts/opinion leaders in bladder cancer is highly preferred.
• A demonstrated track record of success within Medical Affairs, clinical environment and/or scientific function is required.
• Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues is required.
• Global mindset and ability to partner cross culturally/regionally is required.
• In-depth knowledge of study/clinical methodology, study/clinical data reviews and analysis is preferred.
• A demonstrated track record leading highly matrixed, cross-functional work teams comprised of high-level managers and executives is required.
• Experience developing and managing strategic relationships with medical experts/opinion leaders is required.
• Proven ability to act as a medical spokesperson for external audiences is required.
• Excellent knowledge of study execution, benefit risk management and life-cycle management are preferred.
• Proven track record of ethical decision making is required.
• Experience in patient advocacy and engagement is highly desirable.
• A minimum of 30% international travel is required.