Director, Clinical Pharmacology

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.

Essential Functions

• Directs and Implements clinical pharmacology plans and programs according to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug Development Plan (DDP)
• Leads the development of Clinical Protocols to meet CDP objectives.
• Serves as Study Director/Clinical Pharmacology Lead and drives the execution of the study from protocol concept to final report including interpretation of clinical data.
• Serves as Medical Monitor (where applicable) to review and monitor study data.
• Implements strategies to identify, monitor and resolve clinical program/trial issues.
• Interprets study data and develops integrated summaries of Clinical Pharmacology data as it relates to safety and efficacy.
• Contributes to Clinical Pharmacology expertise and content to regulatory documents (e.g. briefing books, INDs, NDAs etc.) and represent Clinical Pharmacology in discussions with Health Authorities.
• Reviews 3rd party work products and deliverables to approve payment of invoices and resolve discrepancies.

Requirements

• A PhD, MD or PharmD degree with at least 5 years of pharmaceutical industry related experience as a Clinical Pharmacology Project Lead.
• A thorough understanding of global regulatory requirements on the Clinical Pharmacology and Translational Medicine aspects of drug development.
• A thorough understanding of standard Clinical Pharmacology computational programs.
• Experience in oncology, pediatric development and translational medicine is preferred but not required.
• Strong inter-personal skills are required since the job requires substantial interaction within the assigned Business Group as well with other Pre-clinical, Modeling, and Translational Science Groups.
• Complies with all applicable laws/regulations of each country Eisai does business in.
• Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients or physicians.
• Minimal travel required: less than 10%
• Hybrid Work Arrangement: Tuesdays, Wednesdays and Thursdays in Nutley, NJ

Eisai Salary Transparency Language:

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://us.eisai.com/careers-at-eisai/benefits.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

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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