- Oversee and support 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, Medical Directors/SRP/SRS, and other business functions (Global Medical Affairs [GMA], Safety, Compliance, supply chain and R&D) to ensure timely execution of IIS, collaborative studies or CSSs
- Actively contribute 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.
- Manage monthly/periodic meetings to monitor/ track ongoing status of assigned studies and assist in IIS/collaborative proposal intake, review, and tracking.
- Collaborate with medical team and Medical Affairs Delivery Unit 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.
- 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.
- Manage study and program level budgets, provide budget projection for Business Planning and work with IETL on strategic priorities.
- Forecast, plan, track and execute on program level drug supply requirements.
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Associate Director, Clinical Project Scientist - Horsham, United States - Johnson & Johnson
Description
Johnson & Johnson, is recruiting for an Associate Director, Clinical Project Scientist, Oncology to be located in Horsham, PA.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 .
We are Johnson & Johnson. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our Credo .
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Associate Director, Clinical Project Scientist, in the US Hematology Medical Affairs organization will be responsible for implementation of Investigator Initiated Studies (IIS), collaborative group studies, 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 Hematology Medical Affairs Oncology teams 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 studies 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 act as point of contact with external Investigators and collaborative groups for protocol intake and review, contract/budget negotiations, track clinical supply demand, manage protocol deliverables, including data generation activities (study reports, manuscripts, congress publications). This candidate will also lead a CPS team with people leadership responsibilities.
In this role you will:
