Associate Director, Clinical Project Scientist - Spring House, United States - Johnson & Johnson

Johnson & Johnson

Verified Company

Spring House, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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/coauthor 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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