Eisai Director, BA/PK, Clinical Pharmacology Science (Remote) in Woodcliff Lake, New Jersey
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 responsibility of Director of Bioanalysis and Pharmacokinetics (BA/PK) is to lead the design, analysis, interpretation and reporting of pharmacokinetic data from clinical studies in utilizing state-of-the-art technology. This includes performing pharmacokinetic and pharmacodynamics (PD) data analysis, contributing to PK/PD related regulatory documents and drafting PK/PD sections in support of clinical development, and providing PK/PD perspective on cross-functional teams. Additional responsibilities include assisting in preparing and reviewing bioanalytical plans, protocols and reports to meet regulatory requirements and management of bioanalytical activities (budgeting, auditing CROs, setting up agreements etc).
The incumbent will participate in regulatory interactions as needed. In addition, as most senior BA/PK person on site at ESI, the Director BA/PK will provide managerial oversight for all clinical bioanalytical work and all clinical non-compartmental PK analysis performed in the US or assigned region. Furthermore, the role encompasses liaising on all matters of BA/PK with PCU and CFU staff members both locally and globally.
Conducting PK and PK/PD data analysis; Interpreting PK and PK/PD results for the project teams. 25%
Managing BA activities locally and globally: developing BA global strategy to meet future needs and improve efficiency; reviewing bioanalytical plans and reports to ensure that the reports meet current/future regulatory requirements. 25%
Maintaining (and improving) BA and PK service deliverables PCUs. Assuring quality and timeliness to project teams. 10%
Manage all BA/PK personnel who are part of the CCLO in US office. 10%
Oversee BA/PK services for outsourced studies - in particular to maintain consistency across outsourced CROs. 10%
Improve systems and process as appropriate for optimal efficiency and quality for all global clinical BA and PK work. 10%
Contributing to Global BA/PK Leadership team; joining/contributing to meetings, sharing ideas on innovation in technology, methodology which can improve timelines, quality or cost-effectiveness in the BA/PK area. 10%
Ph.D. in Pharmaceutical sciences, Pharmacokinetics or related discipline or advanced degree with considerable relevant industry or academic experience.
Must have in depth knowledge of PK and analysis tools (eg Phoenix, PKS etc).
Must have good understanding of bioanalytical technology/methods both for small and large molecules.
Must have excellent organization skills and be highly regarded in the in BA/PK area with a strong publication record.
Must have well-grounded experience in drug development concepts - data driven decision making, functioning of project teams/sub-teams, development of protocols, CSRs etc.
Must have understanding and experience of regulatory requirements in the 3 main regions (US, Japan and EU) related to the job and comply with those regulations.
Must have excellent written and oral communication skills. This role will be highly visible in the organization, and influencing skills and the ability to effectively present complex issues will be important assets.
Must have the ability to work in a dynamic team oriented environment as demonstrated by participating in and contributing to cross functional teams is necessary.
Experience in building an internal network of collaborators is desired.
Demonstrate high ethical behavior at all times, whether dealing with colleagues, vendors, patients or physicians and to maintain Eisai's hhc policy.
Minimal travel - less than 10%.
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 state 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 due to a medical condition (including p regnancy-related), or because of your 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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Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai’s policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, p regnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law. Eisai is an Equal Opportunity Employer - Minority / Female / Disability / Vet