Senior Global Medical Affairs Leader, Bladder Cancer

Johnson & Johnson Innovative Medicine • Raritan, NJ

4d • $196,000 - $342,700 • Onsite

About The Position

The Senior Global Medical Affairs Leader (Sr. GMAL) for bladder cancer leads clinical-commercial optimization of product development and life-cycle management strategies and plans for products and compounds within the disease area or therapeutic area. The role partners with the Compound Development Team, Global Commercial Strategy & Operations, and regional Medical Affairs leaders to develop integrated global Medical Affairs perspectives, strategies, and plans.

The leader develops global Medical Affairs strategy and plans based on regional needs, integrates Medical Affairs input into compound development and life-cycle strategies, plans, and trial design from phase IIa through phase IV, and coordinates pre- and post-launch medical activities. The role also leads global publication planning, patient advocacy strategy and initiatives, the ReCAP review process for applicable trials and studies, risk-management activities, and pre-approval access strategy.

The position is based in Raritan, New Jersey, and requires a minimum of 30% international travel. The anticipated base pay range is $196,000 to $342,700. Eligible employees may participate in the company’s pension and 401(k) savings plans and long-term incentive program, and may receive paid leave benefits subject to applicable plans and policies.

Requirements

• An advanced scientific or medical degree, such as an MD, PhD, PharmD, MPH, or other master’s-level degree.
• At least 10 years of combined relevant experience in a medical or clinical environment and/or a scientific function in the pharmaceutical industry.
• Demonstrated track record of success in Medical Affairs, a clinical environment, and/or a scientific function.
• Ability to drive work in complex and changing environments and effectively manage and resolve issues.
• Global mindset and ability to partner across cultures and regions.
• Demonstrated track record leading highly matrixed, cross-functional teams comprising high-level managers and executives.
• Experience developing and managing strategic relationships with medical experts and opinion leaders.
• Ability to act as a medical spokesperson for external audiences.
• Ethical decision-making track record.
• Ability to travel internationally at least 30% of the time.

Nice To Haves

• MD or DO degree.
• Experience in bladder cancer.
• At least five years in a Medical Affairs environment.
• Established network with bladder cancer medical experts or opinion leaders.
• In-depth knowledge of study and clinical methodology, including study and clinical data review and analysis.
• Knowledge of study execution, benefit-risk management, and life-cycle management.
• Experience in patient advocacy and engagement.

Responsibilities

• Lead development of the Global Medical Affairs strategy and plan for assigned compounds based on prioritized regional needs.
• Collaborate with Compound Development Teams to integrate Medical Affairs with the global compound strategy and create a global R&D and Medical Affairs development plan, including a Target Product Profile that represents global and regional Medical Affairs value needs.
• Lead W-MAST, comprising regionally designated Therapeutic Area Medical Affairs Leaders, to create a unified Medical Affairs perspective and voice on the Compound Development Team.
• Provide Medical Affairs input into compound development and life-cycle management strategies, plans, and trial design from phase IIa through phase IV.
• Lead pre- and post-launch medical activities, including global advisory boards, medical symposia, and congress activities, and coordinate regional activities in these areas.
• Partner with regional Medical Affairs representatives to develop integrated global strategies and plans and maintain two-way communication about plans, progress, and decisions.
• Lead development and execution of global publication plans and review and approve publications and scientific congress displays for marketed products and specified compounds in clinical development.
• Lead patient advocacy initiatives and strategy, building and enhancing strategic alliances with national and international stakeholders in support of patient needs and company objectives; assess the patient advocacy landscape and develop an engagement strategy.
• Manage the ReCAP process for review of applicable Medical Affairs-sponsored clinical trials and investigator-initiated sponsored studies.
• Support development of company risk-management strategy and plans; author and review relevant sections of periodic benefit-risk assessment reports and perform Medical impact assessments as required.
• Lead pre-approval access strategy for assigned compounds.

Benefits

• Company consolidated retirement plan (pension).
• 401(k) savings plan.
• Long-term incentive program eligibility.
• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year, with specified higher amounts for eligible Colorado and Washington residents.
• Holiday pay, including floating holidays: 13 days per calendar year.
• Work, Personal and Family Time: up to 40 hours per calendar year.
• Parental leave: 480 hours within one year of a child’s birth, adoption, or foster care placement.
• Bereavement leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
• Caregiver leave: 80 hours in a 52-week rolling period.
• Volunteer leave: 32 hours per calendar year.
• Military spouse time off: 80 hours per calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior