Janssen Scientific Affairs, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Director, Clinical Operations to be located in Horsham, 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 Scientific Affairs, LLC is dedicated to providing medical information and consultative support to the Janssen pharmaceutical companies.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Director, Clinical Operations role is a key interface role accountable to the therapeutic area leadership working across multiple therapeutic areas. The Director, Clinical Operations in collaboration with various operational counterparts in GCDO (internal Clinical Operations partners) as well as R&D, will ensure therapeutic strategy development and the clinical and operational implementation of company sponsored studies, investigator initiated studies and post marketing risk management research programs, through in sourced, outsourced or matrixed organizations. This individual will focus on Phase IIIB and IV studies, post marketing risk management research programs and IIS trials to ensure strategic level plans are executed in a timely and compliant fashion for achievement of Medical Affairs’ research goals. He/she will strategically plan and track various deliverables and projects across Medical Affairs. The Director, Clinical Operations will supervise between 2-6 Clinical Project Scientists.
The Director, Clinical Operations will:
• Provide strategic oversight and active contribution to individual protocol planning and development, as well as provide direction and oversight across all clinical/post marketing research projects. Responsible for managing internal and external study registries.
• Support execution of clinical studies/post marketing research programs, interpretation of results, and preparation of oral and written internal/external presentations, including FDA or Regulatory body submissions as well as external review bodies (e.g., co-license partners and Jansen affiliates); assist in the development, management, and tracking of trial budgets, and in budget and contract development with third party vendors.
• Strategically align and partner with individuals and groups within and outside Medical Affairs (e.g., GCDO, R&D, Global Medical Affairs, Regulatory Affairs, Clinical Compliance) for critical issues resolution related to clinical and outcomes programs and operations, compliance with training requirements, and audit.
• Responsible for strategic oversight for multiple therapeutic area products across portfolio for conduct of all Medical Affairs clinical trials/post marketing research and other Clinical Affairs activities such as steering committees, data safety monitoring boards, investigator meetings, and division meetings.
• Oversee franchise clinical initiatives (program quality, tracking against financial targets, timelines, functional resource allocation in alignment with franchise strategy, clinical processes etc.) in collaboration with functional leadership. May lead cross-functional teams for developing and monitoring strategies for clinical process effectiveness.
• Oversee operational activities associated with the management of educational grants. Ensure all documentation for educational grants is collected in compliance with company SOPs and alignment with TA strategic goals.
• Active participant managing and planning Business Plan and Strategic Plan processes with VP, Medical Affairs. Lead strategic initiatives for Medical Affairs (cross-TA, cross-sector) as assigned.Qualifications
• A minimum of a Bachelor's degree is required
• An advanced degree (i.e. Master's, PhD, etc.) is preferred
• A minimum of 10 years of clinical research and/or project management experience within the pharmaceutical industry is required
• Previous leadership experience in overseeing clinical research and outcomes research programs is required
• Immunology therapeutic area experience is preferred
• Experience developing strategy as well as business goals and objectives across a portfolio is preferred
• Experience managing finances (both clinical and administrative) for a trial/program and across a portfolio is required
• Strong leadership, interpersonal, and communication skills are required.
• Ability to operate in a matrix environment and experience working with cross-functional alliances is required
• Considered by peers as a clinical trials and drug development expert, technically proficient, intelligent, and results oriented.
• Must be a high-performing individual with ability to think creatively, critically, and proactively, with strong problem solving skills.
• Must be able to prioritize, work independently, and have ability to be flexible and manage multiple priorities.
• Experience in real-world evidence trial management is preferred
• This position will be located in Horsham, PA and will require up to 10% domestic and international travelPrimary Location
Janssen Scientific Affairs, LLC (6120)Job Function
Medical AffairsRequisition ID
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