Sr. Global Medical Affairs Leader (GMAL)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Johnson & Johnson is currently seeking a Senior Medical Affairs Leader (Sr. GMAL), daratumumab to join our team in Raritan, NJ. The preferred location for this position is Raritan, N but consideration could be given to other locations.

The Senior Global Medical Affairs Leader (Sr. GMAL), daratumumab, is responsible for leading the strategy for the clinical-commercial optimization of product development and life cycle management strategies and plans for daratumumab in multiple myeloma and plasma cell dyscrasias. S/he will partner closely with Global Commercial and Market Access counterparts, Regional Medical Affairs leaders, and R&D partners to develop integrated global medical affairs perspectives, strategies, and plans.

Responsibilities include:

• Lead the development of Global Medical Affairs (GMAF) strategies and plans 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.
• Partner with regions and global commercial organization to prepare medical-commercial launch strategy and ensure flawless launch execution for line extensions.
• Lead/participate in worldwide medical affairs strategy team meetings, 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 worldwide IEGP process and planning for daratumumab and serve as strategy lead for any Global Medical Affairs company-sponsored studies for daratumumab in closer partnership with Study Responsible Physician(s) and study team(s).
• Lead development and execution of the global publication plan as well as review and approval of publications.
• 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.
• 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

Qualifications

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 hematology and/or multiple myeloma 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 multiple myeloma is preferred
• A demonstrated track record of success within Medical Affairs, clinical environment and/or scientific function is required.
• Demonstrated success in a highly competitive disease area is required
• Experience with launching line extensions and managing worldwide life cycle management strategies is highly recommended
• 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 is required.
• Experience developing and managing strategic relationships with medical experts/opinion leaders 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.

The anticipated base pay range for this position is $187,000 to $322,000.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."