J&J Family of Companies ASSOCIATE DIRECTOR CLINICAL RESEARCH in San Diego, California
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director, Clinical Program Scientist, WAVE Early Development Unit, located in San Diego, CA.
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.
Within Janssen Research & Development, LLC, the WAVE unit is a biotech-like Early Development group that progresses novel compounds from first-in-human through initial Proof of Concept studies. WAVE focuses on addressing key compound developability questions across therapeutic indications, providing data that enable robust decision-making.
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. Proud to be an equal opportunity employer.
The Clinical Program Scientist (CPS) will have broad responsibilities, as a key member of a clinical team responsible for the development and execution of clinical strategies and the clinical and operational implementation of compound clinical programs. The CPS provides active scientific contribution to a cross-functional clinical team developing a molecular entity. The CPS provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, takes responsibility for coordinating completion of clinical study reports and supports preparation of relevant documents for regulatory filings. The CPS will collaborate with Project Physician(s) in monitoring of clinical trial conduct. This role involves extensive team matrix interactions with colleagues from a number of different disciplines.
The Clinical Program Scientist (CPS) will:
Lead and/or manage protocol development, including coordination of protocol-related reviews and writing of protocol; author significant sections of and coordinate writing of IB, CSR and other clinical documents and support scientific discussions with consultants
Serve as the primary contact person for study management
Supervise the initiation, execution and reporting of Phase I and IIa clinical trials
Assemble and coordinate the activities of clinical trial team representatives from supporting clinical departments (Biostatistics, Data Management, Global Clinical Operations, Medical Writing, Regulatory Affairs, Clinical Supplies, Programming, etc.) to ensure all clinical study objectives are achieved.
Provide strategic leadership to manage/address specific project/program-related issues.
Assist with data review and medical monitoring/reporting activities, in concert with the Study Responsible Physician (SRP)
Lead study-related working group meetings and clinical team meetings as needed, including preparation of agenda, minutes, and action items
Support regulatory and EC/IRB submissions and work with regulatory team to consolidate clinical response to regulatory or EC/IRB questions
Coordinate data visualization/DMC activities as well as provide study updates to team members and management
Work with the team to: manage study timelines, oversee study budgets and review recruitment plan, track study progress, coordinate trouble shooting and issue resolution, develop ICF and CRFs, select vendors, review vendor budgets, scope of work and training manuals
Provide input and feedback for: country/site feasibility evaluation and country/site selection, mitigation and contingency plans, and trial plans, monitoring guidelines, data management plan, and other clinical trial documents
Work with SRP to: develop content and plan for investigator meetings, including protocol/compound training, and review incoming study data for trends and issues, review protocol deviations, provide retraining to sites and monitors, work with data managers and vendors to reconcile data discrepancies
Review statistical analysis plan, review data listings and tables, contribute to data mining strategy, interpret study results, and review clinical study report, in addition to being point person for vendor contract negotiation, and execution
Travel up to 10% (domestic and international) may be required.
PhD in a biomedical field and at least 4 years industry experience, or a Master’s degree with a minimum 8 years industry experience is required, or the equivalent training/experience required.
3 or more years previous industry experience with human trial conduct with pharmaceuticals is required.
Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings is required.
Excellent English oral communication and technical writing skills are required.
Excellent interpersonal skills are required.
Proficiency in the use of Microsoft suite of software products including Excel, Powerpoint and Word is required.
Experience leading a multidisciplinary project team is strongly preferred.
A track record of publication in peer-reviewed journals as corresponding author is preferred.
Ability to travel up to 10% (domestic and international) preferred.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-California-San Diego-
Janssen Research & Development, LLC (6084)
J&J Family of Companies
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