Associate Director, Translational Medicine Study Responsible Physician- Immunology

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

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Spring House, Pennsylvania, United States of America, US064 CA San Diego - 3210 Merryfield Row

Job Description:

About Innovative Medicine

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.

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

 About Immunology

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 Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Johnson & Johnson is recruiting for an Associate Director, Study Responsible Physician (SRP) Immunology Translational Sciences and Medicine (TSM) to be located in Spring House, PA, Cambridge, MA, San Diego, CA.

The primary focus of this Associate Director, Study Responsible Physician (SRP) position within the Immunology Translational Science and Medicine (TSM) department is to lead the safety strategy; develop the medical review and oversight plans and conduct medical surveillance and interpretation of safety findings for clinical pharmacology (CPP) and Early Development (ED) studies as outlined in the asset clinical development plan (CDP) to ensure patient safety, data integrity, and protocol compliance.

For TM Accountable studies the TM SRP will provide medical leadership to the study teams, including leading the design and execution of clinical trial protocols, the strategy for medical review and conduct medical surveillance and interpretation of safety findings and communication of results to TSM leadership, and CDT (compound development team) as needed.  For CPP accountable studies, the TM SRP will partner with the CPP lead, overseeing the clinical aspects of study design, protocol development and execution, being accountable for the medical monitoring and safety strategy of these trials. 

This work is at its core a deep collaboration between Disease Area experts, CPP, Clinical and Non-Clinical Safety, Translational Science (Biomarker), Translational Medicine (Clinical) experts, Immunologic Pathway experts and other relevant stakeholders at the CDT. The TM SRP collaborates with Global Development Operations (GDO) and the entire Trial Team to operationalize studies efficiently and effectively.

PRINCIPAL RESPONSIBILITIES:

• Medical Monitoring (MM): Provide medical oversight for clinical trials. Functions as the clinical lead with SRP and/or MM role responsibilities on clinical pharmacology and other ED studies, as needed.
• Eligibility Reviews: Manages actions to be taken during a study as they relate to subject eligibility and safety. Ensure that participant eligibility meets study criteria and provide guidance on any medical issues that arise.
• Lab Reviews: Assess laboratory data and pharmacodynamics results to identify any safety signals or concerns
• Data Review: Review clinical data, adverse events, and adverse drug reactions in collaboration with the clinical
• Safety Oversight: Identifies and assesses medical risks and mitigation plans prior to and during clinical trials. Provide medical guidance on p