Senior Director, Clinical Research - Oncology - Lenvima
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The Sr. 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 Man studies through Phase I/II/III Clinical Trials.
The incumbent will 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.
Primary Responsibilities include but are not 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
• Leading and mentoring a team of direct reports, in addition to cross functional study teams, providing coaching, training, career development and effective feedback
• 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 Oncology Clinical Development experience in lieu of Board Certification.
• 5+ years of Oncology Clinical trial experience within industry; demonstrated experience and involvement in clinical trial design or execution.
• Demonstrated competence as Study Director/Medical Monitor and prior experience working with the FDA or EMEA on responses to inquiries for study related information. Prior supervisory experience preferred.
• Clinical trial experience in the setting of pharmaceutical industry with demonstrated experience and involvement in clinical trial design or execution
• 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)
BENEFITS OF OPPORTUNITY:
• Our Company commitment to the oncology portfolio with establishment of an Oncology Business Group that is responsible for the full cycle of development. Seamless execution of projects via end-to-end accountability from discovery to NDA/BLA/MAA filing.
• “Eisai is a mid-size company with a research mindset, a biotech spirit and flexible, hands-on approach. Employees have the ability to "wear different hats," i.e., they are given diversified job responsibilities and may assume accountability in various functions. As a result, Eisai offers a tremendous opportunity to learn, develop oneself and acquire a unique set of skills. It’s a positive and collaborative work environment. People are excited about their work and genuinely trying to do a good job!”
• Opportunity to lead a global registrational trial in solid tumors
• Autonomous environment that empowers the Oncology Business Group to drive the product portfolio and be accountable for performance; High visibility within Eisai Inc. as the key interface with novel target cancer research.
• Openness to external innovations enhanced by active collaborations with external talents
• Strong demand for innovation mindset with a priority on insight into the “patients” reality
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