Associate Director Clinical Project Scientist - 2406161364W

　　Description

　　Johnson & Johnson is recruiting for an Associate Director, Clinical Project Scientist, Oncology. The position will be located in High Wycombe, United Kingdom; Beerse, Belgium; Breda, Netherlands; or Allschwil, Switzerland. Remote work options within the United Kingdom and the European Union may be considered on a case-by-case basis and if approved by the company.

　　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.

　　We are Johnson & Johnson. 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 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.

　　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 closeoutAssists 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

　　Required /preferred:

　　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 preferred

　　Ability to work 5 days a week

　　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 equal opportunity employer, 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.

　　Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse

　　Other Locations Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Switzerland-Basel-Country-Allschwil, Europe/Middle East/Africa-Netherlands-North Brabant-Breda

　　Organization Janssen Research & Development, LLC (6084)

　　Job Function Clinical Development & Research - Non-MD

　　Req ID: 2406161364W