Associate Director, Clinical Project Scientist

About this role

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Project/Program Management Group

Job Sub Function: Project/Program Management

Job Category: Professional

All Job Posting Locations: Horsham, Pennsylvania, United States of America, New Jersey (Any City), New York (Any City)

Job Description: About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a The Associate Director, Clinical Project Scientist to be based in Horsham, PA.

Purpose: The Associate Director, Clinical Project Scientist, is responsible for implementation of Investigator Initiated Study(ies) (IIS), collaborative group study(ies), and company sponsored studies (CSS), including both interventional and registry studies. In this role, the individual will be required to work in collaboration with US Medical Affairs Oncology staff as well as Global Development partners to review submitted IIS/collaborative proposals and execute, track, manage and oversee approved IIS/collaborative protocols. In support of company sponsored studies, the candidate must ensure timely and compliant execution of the study(ies) in partnership with functional leads. The focus of this candidate is to ensure appropriate execution to deliver data that will support evidence generation needs in the US. Additionally, candidate will need to act as point of contact with external Investigators and/or collaborative groups for protocol intake/review, contract/budget negotiations, track clinical supply demand, manage and track protocol deliverables, including data generation activities (study reports, manuscripts, congress publications). Considered by peers as a clinical trials expert, technically proficient, intelligent, and results oriented. Able to think creatively, critically, and proactively, with strong problem solving skills. Collaborative and flexible in personal interactions at all levels of the company.

Key Responsibilities: • Oversees and supports all aspects of internal review and approval of IIS, collaborative clinical studies and company sponsored studies. May oversee and support other medical affairs activities, such as data safety monitoring board, investigator meetings and steering committees. • Collaborate with Investigators/staff, Medical Directors/SRP/SRS, GD and other business related colleagues (Global Medical Affairs [GMA], Safety, Compliance, supply chain and R&D) to build relationships to ensure timely execution of IIS, collaborative studies or CSSs • Actively contributes to protocol/Informed consent planning and development. Collaborates with TA lead, Medical Directors and counterpart in Global Medical Affairs, as needed, to understand asset strategy and data generation priorities across an asset or number of assets. May include interpretation of results and preparation and/or review of internal/external presentations. • As appropriate, manage monthly/periodic meetings to monitor/ track ongoing status of assigned studies and may assist in IIS/collaborative proposal intake, review, and tracking. • Collaborate with medical/GD personnel to assist with execution of clinical studies; interpretation of results; preparation of oral and written internal/external presentations; development, management, and tracking of trial budgets; and budget and contract development with Investigators and, as needed third party vendors. • Proactively interface with internal and external stakeholders to resolve contract/budget negotiation issues. Development and implementation of risk mitigation strategies as well as study timeline management. • Assist with tracking and managing adverse event data collection across trials (IIS and company sponsored); and where appropriate, incorporation into obligatory regulatory documents. Interface with GCO Safety personnel and Global Medical Safety. • Execute and/or oversee franchise clinical initiatives (program quality, tracking against financial targets, timelines, clinical processes, etc) in collaboration with TA 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 • Ensure compliance with internal J&J SOPs including local and global health authority regulations and guidelines

Required Qualifications: • A minimum of a Bachelor's Degree is required, and advanced degree is preferred; knowledge of Oncology therapeutic area is highly preferred. • A minimum of 7 years of experience within the pharmaceutical industry is required with significant experience in

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