Associate Director, Clinical Project Scientist

3 weeks ago

Spring House, United States Johnson & Johnson Full time

Johnson & Johnson is recruiting for an Associate Director, Clinical Project Scientist, Oncology. The position can be located in Spring House, PA; Raritan, NJ; High Wycombe, UK; Beerse, Belgium; Breda, Netherlands. Remote work options within the United States, United Kingdom and European Union may be considered on a case-by-case basis and if approved by the company.

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 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 preferred
- Experience with drug development in hematologist malignancies 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

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