Janssen Scientific Affairs, LLC is recruiting for an Associate Director- Clinical Project Scientist, Neuroscience . This position will be located in Titusville, NJ. The position may require up to 15% domestic and international travel.
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 Associate Director, Clinical Project Scientist role is a key interface role in collaboration with the CNS Medical Affairs leadership to act as a liaison between therapeutic strategy and the clinical and operational implementation of company-sponsored or investigator-initiated studies conducted through in-sourced, out-sourced or matrixed organizations . The CPS will be responsible for project management activities that support Phase IIIb - Phase IV clinical trials, investigator-initiated studies, scientific communications/publications, and other research-related activities to ensure strategic and tactical level plans are executed in a timely and compliant manner. The CPS will also participate in protocol development, interpretation of results, and preparation of scientific communications.
Key Responsibilities Include:
R esponsible for global strategic oversight of multiple projects for CNS Medical Affairs such as clinical trials, non-interventional research activities, post-marketing research programs, publications, and other activities such as steering committees, data safety monitoring boards, investigator meetings, and division meetings.
Provides strategic oversight and active contributions to the planning and development of research protocols, as well as provide direction and oversight across all CNS Medical Affairs research projects, and other research-related activities.
Assists in the management of clinical studies, interpretation of results, and preparation of oral and written communications for internal and external presentations, including FDA or health authority submissions as well as external review bodies. Assists in the development, management, and tracking of project budgets, and in budget and contract development.
Strategically aligns and partners with individuals and groups within and outside CNS Medical Affairs (e.g., GCO, LSO/GMS, PGSM, GMA, Regulatory Affairs, QA, Health Care Compliance, and the Law Department) for resolution of critical issues related to CNS Medical Affairs research programs and operations, tracks compliance with training requirements, and assists in audits.
Oversees franchise clinical initiatives (program quality, tracking against financial targets, timelines, clinical processes, etc.) in collaboration with functional leadership. May lead cross-functional teams for evaluating new product ideas, implementing franchise business strategies, and/or developing and monitoring strategies for clinical process effectiveness. Responsible for management of adverse event data collection for PSUR, PADER and other annual regulatory obligations. Interfaces with Global Medical Safety and other safety personnel.
Co-manages and is accountable for CNS Medical Affairs financial budgets across the entire portfolio, and acts as a primary liaison with business and finance units. Responsible for budget and contract development with third party vendors.
A minimum of a Bachelor's Degree is required, and an advanced or professional degree in healthcare or neuroscience is preferred.
A minimum of 8 years of clinical trial experience within the pharmaceutical industry is required, with significant experience in overseeing or managing Phase IIIB - IV clinical trial programs and other research-related activities.
Neuroscience/CNS/Mental health experience and/or exposure is highly preferred.
Strong leadership, interpersonal, and oral/written communication skills are required.
The ability to operate in a matrix environment and experience with cross-functional alliances is required.
People Leadership experience is highly preferred.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Primary Location: North America-United States-New Jersey-Titusville