Associate Director, Clinical Development (INTO)

Job Description - Associate Director, Clinical Development (INTO) (2406226647W) Associate Director, Clinical Development (INTO) - 2406226647W Description Johnson & Johnson is currently seeking an Associate Director, Clinical Development to join our Interventional Oncology team in North America (Spring House or Horsham, PA; Titusville, NJ; Boston MA; Raritan, NJ) or EMEA (Beerse, Belgium; High Wycombe, UK). Remote based positions within the USA may be considered on a case-by-case basis and if approved by the company. The Associate Director, Clinical Development will actively participate and may lead aspects of the development, oversight, and execution of Ph I-IV clinical research trials working closely with Study Responsible Physicians, Clinical Leaders, and other Clinical Project Scientists. The position reports to a more senior Clinical Project Scientist. Essential Functions: In collaboration with the Study Responsible Physician and Clinical Leader, will actively 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. Participates 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. Performs 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. Qualifications: Minimum of a bachelor’s degree in a scientific discipline required, with an advanced degree (i.e., MSc, Ph.D., or Pharm D) highly preferred. 6 years or more of clinical research and development experience, spending at least part of the time within the pharmaceutical industry with leadership experience is required. Experience in Oncology Clinical Development is preferred. Significant knowledge of basic scientific research including clinical oncology research is highly preferred. Required Technical Knowledge and Skills: 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. 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.

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