Senior Director, Clinical Research - Oncology
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The Senior Director, Clinical Research - Oncology within the Clinical Development Department is responsible for providing the medical input and medical oversight for early or late stage Oncology clinical development programs. Strategic responsibilities include design and execution of clinical development plans for oncology products from preclinical research, First in Human studies through Phase I/II/III Clinical Trials. The incumbent will also be responsible for 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.
The incumbent will be accountable for leading and mentoring a team of direct reports, in addition to cross functional study teams, providing coaching, training, career development and effective feedback.
This will be a key senior position in the Clinical Development group. The position carries operational and strategic level responsibilities for providing the clinical development, scientific and medical input , oversight and leadership for Eisai Oncology clinical development programs, with a focus on Early stage clinical development. Strategic accountabilities may include program leadership at IPT level, IPT lead role, design and execution of clinical development plans for oncology products from preclinical research.
The role also incorporates higher responsibilities in Senior Stakeholder Management, Regulatory interactions, and being able to provide input at wider R&D level for the company, acquire adhoc various senior level responsibilities and assignments and contribute to licensing opportunities.
Responsibilities will include but not be limited to:
• 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
• Serving as Study Director and driving 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, reviewing and monitoring 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, organizes Advisory Board meetings (e.g., agenda setting), and identifying and liaising with KOLs 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 the 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. Resource and financial management
- MD Required, Oncology Board Certified or Board Eligible, US or equivalent non-US preferred
- Clinical, Medical or Pediatric Oncologist with solid knowledge and experience of overall and early clinical development with at least 5 years of relevant pharmaceutical industry clinical development experience in cancer clinical research. and involvement in clinical trial design or execution.
• Clinical experience and academic track record in solid tumors or hematologic malignancies is preferred
- A Demonstrated competence and track record at Study Director/ Clinical Lead level. Experience with FDA or EMA regulatory agencies handling responses to inquiries and requests for study related information desired.
- Prior supervisory experience required
- Candidates should have experience and understanding of running clinical studies with substantial interaction with other Clinical Development functions such as Clinical Operations, Regulatory and Data Management.
- The ability to be a self-starter, self motivated and effective in influencing others.
- The ability to provide guidance to Medical Monitors/ Clinical Scientists. Reporting into: Group Head, Executive Director.
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