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Development Safety Excellence Leader
Requisition ID: 6116180315
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 Horsham, PA or one of our local NJ offices.
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 Data Safety Monitoring Committee (DSMC) 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 DSMC process to ensure Janssen meets highest clinical trial patient protection and ethical standards. DSMC 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 15 years of clinical, product development and/or medical safety experience, including 5 years in medical safety is required
- Significant experience leading teams and/or organizations is required
- Experience working across multiple therapeutic areas is required
- Subspecialty medical training is preferred
- Clinical development experience is preferred
- Experience teaching or mentoring others is preferred
North America-United States-New Jersey
Janssen Research & Development, LLC. (6084)
Drug & Product Safety Science