Janssen research & development, l.l.c., a division of johnson & johnson`s family of companies is recruiting for an associate director, clinical project scientist, located in raritan, nj, or possible oportunity for remote work.
At the janssen pharmaceutical companies of johnson & johnson, we are working to create a world without diseaseTransforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires usWe bring together the best minds and pursue the most promising science.
We are janssenWe collaborate with the world for the health of everyone in itLearn more at www.janssen.com and follow us @janssenglobalJanssen research & development, llc is part of the janssen pharmaceutical companies.
The clinical project scientist is a responsible member of a clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound programThe clinical project scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entityThe clinical project scientist provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes responsibility for coordinating completion of clinical study reports and supports preparation of relevant documents for regulatory filingsThis role involves extensive team matrix interactions with colleagues from a number of different disciplinesThe clinical project scientist may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.
You will:
Support the preparation of clinical development plans, trial protocols, and supports the operations group with trial set up and monitoring and assists with completion of clinical study reports
Assist physicians in evaluation of adverse events (pre and post-marketing) for relationship to treatment and supports the interpretation and reporting of results
Assist regulatory affairs in determining requirements for any corrective actions or health authority reporting
Interpret reports and prepare oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
Be responsible for data review in conjunction with other clinical team members
Qualifications
Bachelor`s degree is required, and advanced degree (e.g., ms, rn, rd, phd or pharmd) is preferred.
At least 6 years of clinical research and development experience within the pharmaceutical industry is required
Significant experience with managing/supervising clinical trials, clinical research programs is required.
Experience in cardiovascular, metabolic and/or retinal product development and cross company alliances is preferred.
Experience with cross company alliances is preferred.
Strong interpersonal and communication skills are essential.
Must have the ability to travel annually 5-10%.
Highly preferred that candidate has ophthalmic imaging or reading center experience or ophthalmic research and development experience.
Johnson & johnson is an affirmative action and equal opportunity employerAll 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.
Primary location
United states-new jersey-raritan-920 us highway 202
Organization
Janssen research & development, llc (6084)
Job function
R&d
Requisition id
2105964599w
