Category: Scientific & Clinical
Title: Director, Clinical Research - Oncology
Hours: Full Time, M-F
Location: Woodcliff Lake, NJ
- Providing the medical input and medical oversight for early or late stage Oncology clinical development programs.
- Design and execution of clinical development plans for oncology products from preclinical research, First in Man studies through Phase I/II/III Clinical Trials.
- Successfully lead clinical trials Phase I - III, develop and author the necessary documents (e.g. NDA/CTA submissions, study protocols, Investigator Brochures, regulatory briefing books and regulatory response documents, clinical study reports, etc.) and provide expert clinical oncology input and review of the study data as well as lead publication of documents required.
- Directing and implementing clinical research plans and programs according to established design principles
- Directing the integration of the Clinical Development Plan (CDP) and the Drug Development Plan
- Leading the development of Clinical Protocols to meet CDP objectives
- May serve as Study Director and drives the execution of the study from protocol concept to final report including interpretation of clinical data
- Serving as the Medical Monitor for a study or clinical program, reviews and monitors study safety data
- Implementing strategies to identify, monitor and resolve clinical/program trial issues
- Serving as the clinical/medical team expert to provide direction to all project team functions, organizing Advisory Board meetings (e.g., agenda setting), and identifying and liaising with KOL regarding program strategy and scientific advice
- Interpreting study data and developing integrated summaries for safety and efficacy. Contributing clinical expertise and content to regulatory documents (e.g. briefing books, NDAs, etc.)
- May represent Clinical team in discussions with Health Authorities
- Setting key deadlines and project milestones within function
- Making appropriate budgetary allocations to targeted opportunities
- Reviewing 3rd party (contractors, consultants and vendors) work product and deliverables to approve payment of invoices and resolves issues
- Leading by example to encourage others to prioritize personal and professional development.
- Complying with all applicable laws/regulations of each country in which we do business
- Demonstrating high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians
- Medical Degree
- Board Certification or Eligibility in Oncology is preferred; will consider candidates with industry Oncology Clinical Development experience in lieu of Board Certification.
- Oncology Clinical Trial experience in academics (3-7 years post fellowship experience) with significant clinical trial experience (as a PI on multiple studies) and/or medical practice experience OR industry setting with a minimum of 2 years of related experience and demonstrated experience and involvement in clinical trial design or execution
- Depending on experience candidates may serve as Study Director/Medical Monitor; prior experience working with the FDA or EMEA on responses to inquiries for study related information is required. Prior supervisory experience preferred
- Clinical trial experience in the setting of pharmaceutical industry with demonstrated experience and involvement in clinical trial design or execution is a plus
- Clinical experience and academic track record in solid tumors or hematologic malignancies is preferred
- Must be able to demonstrate the ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
- Able to engage in domestic and international travel to the degree appropriate to support project and business needs
- Innovative and inquisitive with a hands-on, practical approach to achieving deliverables.
- Must be a self-starter, self-motivated and must also be effective in influencing others
- Must be able to provide guidance to Medical Monitors/ Clinical Scientists
- Experience in writing trial synopsis, protocols, IB and study reports; Proficient with MS Office programs (PowerPoint, Excel & Word)
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.