Janssen Scientific Affairs, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Director, Clinical Project Scientist 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 Project Scientist role is a key interface role accountable to the therapeutic area leadership for oncology and hematology. In collaboration with various operational counterparts in GDO as well as R&D, this individual will ensure therapeutic strategy development and the clinical and operational implementation of company sponsored studies, investigator initiated studies (IIS) and post marketing risk management research programs, through in-sourced, outsourced or matrixed organizations. He/she will focus on Phase II – Phase 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. The Director, Clinical Project Scientist will manage and be accountable for budgets for oncology and hematology therapeutic areas across the portfolio. This individual will strategically plan and track various deliverables and projects across Medical Affairs. He/she will supervise between 2-6 Clinical Project Scientists and/or Program Managers.
The Director, Clinical Project Scientist will:
• Have responsibility for global strategic oversight of multiple therapeutic area products (hematology / oncology) 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.
• 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 Janssen 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., GCO, R&D, GMA, Regulatory Affairs, Clinical Compliance) for critical issues resolution related to clinical and outcomes programs and operations, compliance with training requirements, and audit
• 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.
• Co-manage and accountable for Medical Affairs financial budgets across entire portfolio, and act as primary liaison with business and finance units.
• Be a leadership role in the preparation of annual goals & objectives across the multiple therapeutic areas in the portfolio; active participant managing and planning Business Plan and Strategic Plan processes with VP, Medical Affairs.Qualifications
• A minimum of a Bachelor’s degree is required
• An advanced degree (i.e. MS, PharmD, 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/or outcomes research programs is required
• Experience within the Oncology / hematology therapeutic area is required
• Experience developing business strategy and goals & objectives across a portfolio is required
• Experience managing finances (both clinical and administrative) across a portfolio is required
• Strong leadership, interpersonal, and communication skills are required
• Demonstrated ability to operate in a matrix environment and be experienced with cross-functional alliances is required
• The ability to think creatively, critically, and proactively, with strong problem solving skills is required
• The ability to prioritize, work independently, and have the ability to be flexible and manage multiple priorities is required
• This position will be based in Horsham, PA and will require up to 15% domestic and international travelPrimary Location
Janssen Scientific Affairs, LLC (6120)Job Function