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Senior Director-Clinical Review, Neuroscience
Titusville, New Jersey
Clinical Research MD
Requisition ID: 8950180119
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Director-Clinical Review, Neuroscience to be located in Titusville, NJ.
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 primary role of the Senior Director Clinical Review is to assure independent review of assigned pharmaceutical clinical study protocols. As such the Senior Director serves as Chair of the Protocol Review Committee and Subcommittee (PRC/S) for Neuroscience therapeutic area and Established Products. This involves coordinating the reviews, facilitating the meetings, and providing recommendations as formal minutes that are archived. Collectively the primary responsibility of the Chair and the PRC/S is to ensure scientifically valid designs and protection of human subjects in pharmaceutical clinical studies. In addition, the PRC/S considers adherence to issued templates, and global guidance(s) and regulatory expectations. The Chair is the process owner of the relevant SOP(s). The Chair also contributes to development of global protocol templates as a member of the Protocol Community of Practice. Secondary roles include serving on cross-pharma and cross-company initiatives including but not limited to providing clinical and study design expertise to the global Labeling Committee and the Cardiovascular Safety Group. The role also involves supporting Neuroscience development teams by reviewing consistency between clinical development strategy and study protocols.
Main Responsibilities include:
- Chair review and approval of new Neuroscience study protocols for early and late development studies
- Chair review and approval of new Established Products study protocols
- Review and provide guidance to development strategy documents for Neuroscience early and late development projects
- Represent Pharm Clinical Development Function in Global Labelling Committee
- Represent Pharm Clinical Development in Cardiovascular Safety Group
- Create, chair and maintain Pharm wide quality control and improvement initiatives and committees for protocol and other critical SOP development and harmonization efforts
Qualifications for the Sr. Director include:
- An MD or MD/PhD is required
- Ten years' clinical research including 5+ years of pharmaceutical industry experience is required
- Previous supervisory experience is highly preferable
- Advanced training in Neuroscience basic research is an asset
- Board Certification in Neurology, Psychiatry or Internal Medicine is preferred
- A record of publications in peer-reviewed journals is an asset
- Strong leadership skills with the ability to influence without direct authority is preferred
- May require 10-15% annual travel (domestic and international)
United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)
Clinical Research MD