Clinical Development Manager

4 weeks ago

Raritan, New Jersey, United States J&J Family of Companies Full time
Job Summary

We are seeking a highly skilled Clinical Development Manager to join our team at J&J Family of Companies. This role will be responsible for leading aspects of clinical research trials in the Oncology Therapeutic Area Development group.

Key Responsibilities
  • Participate in or lead aspects of medical review of clinical trial data, including adverse events, efficacy data, patient screening/eligibility evaluation, PK/PD data, coding, and other data critical to study endpoints
  • Participate or may lead drafting protocol synopsis, sections of full protocols, informed consent documents, review, and development of Case Report Forms (eCRFs), and other data collection tools against draft protocols and central vendor scope of work
  • Participate in the start-up and day-to-day management of one or more global clinical studies, in compliance with department safety practices, policies, and procedures
  • Partner or lead Cross Functional Trial Team to mitigate issues in initiation and management of one or more clinical trials and participate in review of Monitoring Guidelines, SET/IDMC charter, Statistical Analysis Plan, Data Management, and Safety Management Plans
  • Perform medical monitoring/reporting, evaluates ongoing clinical trial data
  • Liaise with external vendor laboratories and clinical research organizations to develop charters where applicable and ensure the collection and quality of data critical to study endpoints
  • Liaise with Translational Research (pharmacokinetic operations & biomarker operations) to ensure robust sample collection, processing, and tracking
  • Participate in the creation and maintenance of a robust Medical Review plan, medical review forms, and liaise with Integrated Data Analysis & Reporting in set-up, implementation, and maintenance of data visualization tools/medical review interface
  • Participate in or lead aspects of training the central study team, local study team, site personnel or external vendors on protocol, disease evaluation criteria, or other specific aspects of the clinical study
  • Participate and lead aspects of data review and drafting documents for submission to Health Authorities
  • Actively participate in mentorship and training opportunities to expand clinical development knowledge, therapeutic area expertise, and leadership capabilities
Requirements
  • Minimum of a bachelor's degree in a scientific discipline required, with advanced degree (i.e., A minimum of 4 years of experience in a related clinical research position, spending at least part of the time within the pharmaceutical industry with leadership experience is required)
  • Significant knowledge of basic scientific research including clinical oncology research is highly preferred
  • High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards
  • Successful work experience in a matrix team, environment with global cross-functional teams is required
  • Fluent in written and spoken English with excellent oral and written communication skills
  • Working knowledge of the use of Microsoft suite of software products
  • Knowledge of Good Clinical Practices ICH/GCP, drug development process, regulatory requirements for the conduct of high-quality oncology clinical trials including protocol development, medical review, oversight of safety, study conduct, and data quality
  • Ability to travel approximately 10-20% domestic/international travel is required
What We Offer

We offer a highly competitive compensation package, including a base salary range of $135,000 to $232,300, and an annual performance bonus. We also offer a comprehensive benefits package, including medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

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