Eisai US

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 Director, Clinical Pharmacology actively contributes to multi-disciplinary teams by providing innovative and progressive thinking on projects and where appropriate, offers guidance to other team members.

In addition to possessing the scientific expertise, the incumbent must be capable of analyzing and interpreting study data and effectively communicating findings to a broad audience. The Director, Clinical Pharmacology will be relied upon to act independently, within a highly-matrixed clinical development organization and must have the experience and conviction to provide sound input on Clinical Pharmacology activities to a variety of project teams.

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%

Eisai Salary Transparency Language:

The base salary range for the Director, Clinical Pharmacology is from:$200,200-$262,700

Under current guidelines, this position is eligible to participate in: Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. 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.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Right To Work

E-Verify Participation