At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

The Senior Director, ClinicalDevelopment - Oncology within theOncology Business Groupis 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 be responsible for leading Phase I-III clinical trials , developing and authoring the necessary documents (e.g. NDA/CTA submissions, study protocols, Investigator Brochures, regulatory briefing books and regulatory response documents, clinical study reports, etc.) , reviewing study data and providing expert clinical oncology input.

The incumbent will be accountable for leading cross functional study teams, providing coaching, training, career development and effective feedback. This will be a key position providing Medical Leadership on the Global Clinical Development Team. 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 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 datal 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

Job Qualifications:

• MD Required, Oncology Board Certified or Board Eligible, US or equivalent non-US preferred. - MD Required. Prefer board certified or board eligible, US or equivalent non-US, Medical or Pediatric Oncologist with solid knowledge and experience of overall and early clinical development in particular.
• Fiveor more years of relevant pharmaceutical industry clinical development experience in cancer clinical research. Absence of oncology board certification not an exclusion criteria per se, however must be compensated by significant additional clinical development experience in oncology.
• Medical or Pediatric Oncologist with solid knowledge and experience of overall and early clinical development with at least 2 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, with completion ofan oncology fellowshipis 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.
• 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 the Vice President.

Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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