Associate 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.
The Associate Director, Clinical Pharmacology candidate is expected to be clinical pharmacology lead on at least 3 projects and is expected to have such experience in previous job function in pharmaceutical industry. The candidate should have the appropriate education (PhD or MD/PhD) and worked at least 3 years in a similar capacity in the pharmaceutical industry. The candidate is expected to be an active contributor to the multi-disciplinary project teams, providing innovative and progressive thinking to projects and where appropriate guidance to other team members.
This person 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 various project teams with regard to clinical pharmacology related activities. In addition to the scientific, technical skillset required, the incumbent must also be capable of analyzing and interpreting study data to then effectively communicate such findings to team members and non-scientific personnel alike. The candidate is also expected to have a thorough understanding of the global regulatory requirements on clinical pharmacology and biopharmaceutical aspects of drug development. A prior perience in the therapeutic areas such as epilepsy, neurodegenerative diseases, autoimmune disorders, or metabolic disorders is considered as a plus but not a requirement.
Study Management 30%
* Serves as Study Director/Clinical Pharmacology Lead for selected trials and delivers final protocol, implementation strategy, and clinical data review plans.
Clinical Pharmacology Expert 30%
* Serves as SME to provide input to project teams across functions, presents at Advisory Board meetings, and liaises with identified Key Opinion Leaders (KOLs) regarding protocol/study strategy and issues.
CP and TM components of CDP Development and Management 10%
* Assists the project team clinical lead in the planning, implementation, managing and reporting of CDPs and programs.
Clinical Research Protocols 10%
* Develops Clinical Protocols to meet the objectives of the CDP
Data Integration Analysis 10%
* Interprets study data and develops integrated summaries of Clinical Pharmacology data as it relates to Safety and efficacy, under supervision of more experienced Clinical Pharmacology staff.
Resource Management 5%
* Obtains and manages resources (tools, systems, vendors, etc.) as appropriate
* Assists in setting deadlines and related milestones within department
* Delegates activities to team members to focus on more complex issues and provide opportunity for employee development.
* Manages contractors and ensures that contractors, consultants and vendors complete assigned work according to agreed timelines.
* Complies with all applicable laws/regulations of each country in which we do business
* Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors patients, or physicians
* Reports legal, compliance and ethical violations in a timely manner.
* MD: Experience in Clinical Research methods and processes
* PhD/PharmD: Experience in Clinical Research methods and processes in industry setting required
* A minimum of 3 years industry-related experience is required.
* Candidates possessing only PharmD credentials must also show evidence of successful completion of a CP fellowship experience.
* Experience in neuroscience, internal medicine, pediatric indications and translational medicine is not required but preferred.
* Minimal travel required (<10%)
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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