Janssen pharmaceutical, a member of johnson & johnson`s family of companies, is recruiting for multiple associate director clinical project scientists, solid tumors-clinical development, oncologyThese positions can be remote based within the u.sOr located in any of our janssen locations such as spring house, pa, raritan, nj, or la jolla, ca.
At the janssen pharmaceutical companies of johnson & johnson, what matters most is helping people live full and healthy livesWe focus on treating, curing and preventing some of the most devastating and complex diseases of our timeAnd we pursue the most promising science, wherever it might be found.
We are janssenOur mission drives usOur patients inspire usWe collaborate with the world for the health of everyone in it.
As the associate director, clinical project scientist, you are 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 scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entityThe clinical scientist provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and clinical study reports and supports preparation of relevant documents for regulatory filingsThe clinical scientist will collaborate with study responsible physician(s) in monitoring of clinical trial conductThis role involves extensive team matrix interactions with colleagues from a number of different disciplines.
Primary responsibilities include:
Supports medical monitoring and reporting, evaluates clinical trial adverse events, reviews clinical laboratory results
Participates in preparation of clinical development plans, trial protocols and clinical study reports
Interacts with clinical investigators
Support clinical operations during trial set up, conduct, monitoring, and closeout
Assists data management with the review of clinical data and query resolution
Works closely with quality management & assurance to ensure flawless execution of clinical trials
Assists with drafting responses to questions from ethics committees and health authorities
Supports integrated document development for marketing authorization filing
Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
Supports preparation for the fda advisory committee and eu oral explanation
Assists regulatory affairs in the development of drug regulatory strategies
Support general clinical/medical affairs activities involving product evaluation, labeling and surveillance
Reviews medical literature and related new technologies
May be asked to assess/co-author medical publications emerging from the team and its affiliates
Qualifications
A bachelor’s degree is required; advanced degree (e.g., ms, rn, rd, phd or pharmd) is preferred
A minimum of 6 years of clinical research and development experience preferably within the pharmaceutical industry
Experience in oncology therapeutic area is required
Fluent in written and spoken english
Working knowledge of the use of microsoft suite of software products including excel and word
Experience and knowledge of good clinical practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
Johnson & johnson family of companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Eradicate cancer
Primary location
United states-pennsylvania-spring house-welsh & mckean roads
Other locations
North america-united states, north america-united states-california-la jolla, united states-new jersey-raritan
Organization
Janssen research & development, llc (6084)
Job function
R&d
Requisition id
2105969663w
