Director Clinical Science and External Research Johnson & Johnson Irvine

Job description
This leader is accountable for leading the Franchise CR&D external research collaborations including the IIS process, ensuring compliance with company policies and legal requirements. This individual is responsible for establishing and maintaining a strong partnership with the Clinical R&D Franchise leader and aligning with the Clinical team to manage the IIS programs, manage external research, e.g., external registries, connection to the Enterprise Epidemiology Group, manage a robust review process for the evidence generation strategies for NPD projects and legacy products and manage the evidence dissemination review process within the Franchise.

Under the general direction of the Leader of Clinical R&D for the Franchise and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position: Leads the investigator-initiated study (IIS) review, implementation and management, and partners with Franchise leaders to align and integrate the IIS evidence strategy with the larger global evidence plan for the Franchise. Connects with the appropriate internal and external experts to develop a strategy to determine when and how to utilize internal data and external data, research, and registries to support evidence needs to demonstrate the value of new and existing products. Provides independent review and input into development of clinical trial protocols and dissemination, as needed. Supports review of clinical evidence generation strategies developed across platforms within the Franchise to ensure robust scientific review with appropriate partners within CR&D Franchise, Operations, BSDM, Medical Affairs, etc. (Depending on the Franchise, this may include conducting strategic assessments (e.g., gap analysis) via literature review and providing clinical/scientific support to developing claims, pre- and post-market clinical strategy, scientific communication and publication plan for key products in development and for legacy products). Working with Clinical Science and External Research counterparts in other Franchises, creates a community of practice to assess proposed new / amendments to policies / regulation / guidance documents for the CR&D COE as well as monitor and influence external activities related to registry development, analysis and data usage. Provides technical leadership to support both internal and external taskforces involved in the development of new / proposed amendments to policies, regulations, etc. Connects with research community to understand and translate advances in clinical science into the franchise clinical research strategies and protocols. Possesses advanced understanding and maintains current knowledge of regulatory requirements and industry standards on scientific communication and publication development. Serves as an internal SME on these topics and will collaborate with counterparts in the other Franchises as well as with US and EMEA Regulatory partners. Develops and maintains relationships with internal and external customers (e.g., key opinion leaders, vendors, etc.) for long-term business opportunities and to understand and communicate customer needs. Additional responsibilities that may be required within a particular Franchise: Independently, or in collaboration with Franchise associates, perform monthly journal review, may manage regular evidence compendia and scientific platform generation, may maintain centralized evidence library and search platform. Collaborate with Franchise leaders to support strategic publication planning and execution. Act as a liaison to the J&J enterprise committees around publications to stay abreast of J&J policies and regulations.

A Bachelor’s degree, Master’s degree, PhD or other advanced degree in Biological Science or related discipline, with a minimum of 10 years related scientific / technical experience, including leadership / management roles within Clinical Research is required. Strong experience in medical devices, especially in clinical and surgical research science, is essential. Relevant industry certifications are preferred (i.e., CCRA, RAC, CDE). A minimum of 3 years supervisory experience is a must. Experience with medical writing and systematic literature review highly preferred. A deep expertise with medical device clinical development is essential. The ability to understand and distill complex scientific information and knowledge of medical device research processes is required. Additional knowledge/experience with pharmaceutical research processes is a plus. The ability to work in a collaborative and multi-disciplinary environment is needed. Additional requirements include: people management experience, excellent written and oral communication/presentation skills, ability to use PC and associated software such as Microsoft PowerPoint, Excel and Word. This position is located in Irvine, CA and will require up to 20% travel.

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