Johnson & Johnson Careers
Development Safety Excellence Leader
Titusville, New Jersey; Raritan, New Jersey; Spring House, Pennsylvania; Horsham, Pennsylvania
Requisition ID: 7900180725
Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Development Safety Excellence Leader to be located in Titusville, NJ, Raritan, NJ, Horsham, PA or Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The GMS Development Safety Excellence Leader is responsible for ensuring implementation of optimal development safety strategy across all compounds in development. In addition, the Leader oversees clinical trials safety data monitoring process and various internal expert safety groups such as Hepatic Safety Group, CV Safety Group and Renal Safety group. The Leader also chairs the Janssen Safety Assessment Committee (SAC) evaluating anticipated events per FDA regulation.
The leader oversees training and mentors Medical Safety Officers to implement optimal development safety strategy for all early- and late-phase development products. The development safety strategy focuses on proactive and efficient steps that can be taken ensure appropriate clinical trials subject protection, reduce product development risk, and positively impact benefit-risk to patients.
The leader oversees clinical trials safety data monitoring process to ensure Janssen meets highest clinical trial patient protection and ethical standards and plays an essential role in drug development and regulatory process. The leader also oversees internal expert safety groups, which provide consultations to safety management teams on the most challenging issues across our development pipeline.
As chair of the Janssen SAC, the leader serves with other senior members of functions including Biostatistics, Epidemiology and Clinical Development to ensure appropriate safety monitoring of anticipated events across all functional areas, and adherence to FDA requirements. The leader collaborates with internal partners (e.g. Discovery Sciences, Global TA, Medical Safety, Biostatistics, Epidemiology) and external partners (e.g. academic experts, global health authorities) to continually advance development safety science and strategy.
The GMS Development Safety Excellence Leader makes important critical decisions as chair of the SAC on clinical trials safety issues. The decisions could alter benefit-risk to clinical trials subject, as well as impact the conduct or continuation of clinical trials. Thus, the decisions made by the leader will have great impacts to patients and new product development.
• A Medical Doctor with a minimum of 10 years of clinical or product development experience is required
• Additional Medical safety experience is preferred
• Significant experience leading and influencing teams and/or organizations is required
• Experience working across multiple therapeutic areas is required
• Subspecialty medical training is preferred
• Experience coaching and mentoring others is preferred
• This position will be located in Titusville, NJ, Raritan, NJ, Horsham, PA or Spring House, PA and may require up to 10% travel including international.
United States-New Jersey-Titusville
North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)