Senior Director, Clinical Leader Ophthalmology
Janssen Research and Development, L. L. C , a member of Johnson and Johnsons Family of Companies, is recruiting for a Senior Director, Clinical Leader Ophthalmology to be located in Raritan, NJ. 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 Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture celebrating the uniqueness of our employees and committed to inclusion.
- Serve as a Clinical Leader in the Cardiovascular/Metabolism/Retina (CVMR) Translational & Experimental Medicine Group, with a focus on drug development for retinal projects. Provide strategic, clinical, and scientific leadership of Phase 0 through Ph2a clinical trials, including mechanistic studies and clinical pharmacology studies.
- Provides active medical and scientific contribution to a matrixed cross-functional Compound Development Team and the Clinical Team, among others. Team matrix interactions may include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology and other scientific and business related disciplines.
- Accountable for the design of the Clinical Development Plan
- Accountable for the development of the Translational Early Development Plan which describes the overall clinical development strategy for early stage compound(s) in collaboration with CVMR Discovery, Biomarkers, Development, and other functional partners.
- Leads the Clinical Team, responsible for the timely completion, content, and quality of key deliverables including protocols, clinical study reports and submissions to health agencies
- Accountable for the medical oversight, conduct, and analysis of the appropriate first in human (FIH), proof of pharmacology (POP), proof of mechanism (POM), and proof of concept (POC) studies for NME early development programs and mechanistic trials and clinical pharmacology studies supporting all phases of development for the CVMR portfolio.
- Provides strategic leadership on managing/addressing specific project/program-related issues and presenting to and negotiating with the CVMR and Janssen leadership teams on development plans or program-related issues.
- Presents and/or responds to questions at meetings with Health Authorities, including FDA advisory committee meetings and/or CHMP presentations.
- Provides key input into diligence activities.
- Participates or leads cross-departmental or cross-functional projects with broad Janssen impact.
- Authors abstracts and manuscripts for publication based on clinical trial data.
- Builds credible relationships with opinion leaders and may act as company spokesperson regarding publication of research findings and presentations to relevant health authorities and consultant/advisory meetings.
OTHER RESPONSIBILITIES / DETAILED DUTIES:
- Participate on and may lead cross-functional teams for evaluation of new scientific opportunities, disease areas, product ideas, implement franchise business strategies, etc.
- Assess external clinical research proposals involving company products relevant to company's mission
- Reviews medical literature and related new technologies
- May be asked to assess medical publications emerging from the Team and its affiliates
- MD (or equivalent) in relevant area with appropriate post-doctoral training and certification
- Board certification in Ophthalmology is preferred, but other clinical training with prior experience in Ophthalmology will be considered.
- Detailed and thorough understanding of ophthalmologic disorders, in drug development, and in methodology relevant to clinical research is required.
- Requires at least 5 years of experience in early development clinical research and development (including Phase 0-2a studies) or academic clinical research. Drug development experience is preferred.
Technical Knowledge and Skills:
- Fluent in written and spoken English
- Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
United States-New Jersey-Raritan-
Janssen Research & Development, LLC (6084)