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.
Job Summary:
The responsibilities of the Director of Clinical Pharmacology, Bioanalysis, and Pharmacokinetics (BA/PK) are both to provide direction, planning, and execution of the Clinical Pharmacology programs and to lead the design, analysis, interpretation, and reporting of pharmacokinetic data from clinical studies in utilizing state-of-the-art technology with innovative thinking. This includes serving as a study director of Clinical Pharmacology studies and also performing pharmacokinetic and pharmacodynamics (PD) data analysis, contributing to clinical pharmacology-related documents in support of clinical development, and providing clinical pharmacology perspectives 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. Furthermore, the role encompasses leadership liaising on all clinical pharmacology matters with global cross-functional teams.
Essential Functions:
- Providing scientific leadership on global Clinical Pharmacology (CP) strategy and executing the CP program as CP representative of projects; developing CP part of Clinical Development Plan/Drug Development Plan, identifying CP studies required for NDA/BLA filing, leading CP contributions to all regulatory documents (including authoring CTD module 2.7.2)/reviews/responses while managing strict timelines.
- Designing and directing CP studies as study director; developing protocol concept sheets and protocol, driving the execution of the protocol with close collaboration with study team members, interpreting results, and delivering the clinical study report.
- Conducting PK and PK/PD data analysis; interpreting PK and PK/PD results for the project teams.
- 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.
- Maintaining and improving BA and PK service deliverables to project teams. Assuring quality and timeliness to project teams.
- Oversee BA/PK services for outsourced studies – in particular, to maintain consistency across outsourced CROs.
- Improve systems and processes as appropriate for optimal efficiency and quality for all global clinical BA and PK work.
- Contributing to global CP/BA/PK team; joining/contributing to meetings, sharing ideas on innovation in technology, the methodology which can improve timeliness, quality, or cost-effectiveness in the CP/BA/PK area.
Requirements:
- MD/Ph.D./PharmD in Clinical Pharmacology, 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 a good understanding of bioanalytical technology/methods both for small and large molecules
- Extensive experience in Clinical Research methods and processes in an industry setting required
- Must have excellent organization skills and be highly regarded in the in CP/BA/PK area with a strong publication record.
- Must have well-grounded experience in drug development concepts – data-driven decision making
- Must have understanding and experience of regulatory requirements in the 3 main regions (the 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.
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
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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.
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:
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