Director, Global Medical Affairs Lead - Pre-Approval Access

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine

The Director, GMAL Pre‑Approval Access – Study Responsible Physician (SRP) is accountable for providing medical and scientific leadership for Oncology Pre‑Approval Access (PAA) programs globally, serving as the primary Study Responsible Physician for PAA activities. In addition to core PAA responsibilities, this role will assume supplementary SRP responsibilities for select Global Medical Affairs (GMAF) clinical trials, ensuring scientific integrity, operational excellence, and compliance across assigned Medical Affairs studies.

Primary Responsibilities – Pre‑Approval Access (PAA) SRP

·       Serve as Study Responsible Physician (SRP) for assigned PAA programs and conduct medical review of individual patient requests.

·       Review HCP submissions to determine patient eligibility based on protocol criteria and benefit–risk considerations.

·       Partner with GMALs and CDTLs on complex or exceptional eligibility cases.

·       Maintain expertise in clinical trial protocols, treatment guidelines, and PAA criteria.

·       Collaborate with Post Approval Delivery Unit colleagues to track cases in the Global Trial System.

·       Ensure compliance with SOPs, GCP, regulatory requirements, and internal PAA policies.

·       Partner with regional Medical Affairs teams to obtain additional clinical context as needed.

Supplementary Responsibilities – GMAF Clinical Trial SRP

·       Provide medical and scientific oversight for assigned GMAF-sponsored clinical trials.

·       Review and approve study protocols, informed consent forms, and medical review plans.

·       Serve as primary medical contact for investigators and internal study teams.

·       Support regulatory, safety, and compliance activities.

·       Contribute to analysis, interpretation, and dissemination of study results.

·       Ensure alignment with the Integrated Evidence Generation Plan (IEGP).

Qualifications

·       MD (or equivalent medical degree) required

·       Oncology clinical experience required

·       Board certification in Oncology preferred

·       Minimum 5 years experience in Medical Affairs or clinical research

·       Prior experience as SRP strongly preferred

Additional Information

Approximately 10% domestic and international travel may be required. This role is remote-based with periodic travel to global meetings.

The anticipated base pay range for this position is $199,000 -