Associate Director-Clinical Project Scientist-Oncology
- United States
Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director, Clinical Project Scientist, Oncology, preferably located in Los Angeles, CA, Spring House, PA, or 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 neuroscience, oncology, immunology, 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.
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 program. The Clinical Scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entity. The Clinical 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 filings. The Clinical Scientist will collaborate with Study Responsible Physician(s) in monitoring of clinical trial conduct. This role involves extensive team matrix interactions with colleagues from a number of different disciplines.
- Supports medical monitoring and reporting, evaluates clinical trial adverse events, reviews clinical laboratory results
- Participates in preparation of clinical development plans, trial protocols
Interacts with clinical investigators
- Support Clinical Operations during trial set up, conduct and monitoring
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
- Drafts and coordinates completion of clinical study reports
- 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
- A minimum of a Master's is required; advanced degree (e.g., RN, RD, PhD or PharmD) is preferred
- A minimum of at least 8 years of clinical research and development experience required, preferably within the pharmaceutical industry.
- 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 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-Los Angeles-
United States, United States-New Jersey-Raritan, United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)
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