Associate Director, Clinical Project Scientist

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.

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
  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
• 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

Qualifications

REQUIREMENTS

• Bachelor’s degree required. An advanced degree (MS, MSN, RN, PharmD, PhD) preferred.
• A minimum of 6 years of progressively responsible experience in clinical research and development, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) or academia is required.
• Experience in oncology therapeutic area is preferred
• Experience with clinical trials including development of protocols, case report forms, informed consent, study initiation, protocol training, and clinical data monitoring Preferred
• Excellent written communication, oral communication, and presentation skills are required.
• The individual must have demonstrated ability to work and lead in a cross-functional team environment and be flexible and adaptable. Ability to travel up to 10% required.

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.

Eradicate Cancer

Primary Location
Switzerland-Zug-Zug- Organization
Cilag GmbH International (8525)
Job Function
R&D
Requisition ID
2005869273W