Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since then we have rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.
Eisai recognizes that we are the Company’s greatest asset. To this, Eisai is committed to providing us an enabling and empowering work environment that allows us to grow and thrive. In our diverse organization, we adhere to a strict commitment to our values of Integrity, Respect, Professionalism, Quality and Teamwork. We therefore invite you to explore this job opportunity or any others that may match your qualifications and interests.
Eisai is searching for a creative, resourceful, integrative thinker to lead Translational Science research through desiging and executing Clinical Pharmacology activities in the development of innovative drugs in the neuroscience portfolio. This Associate Director/Director role will provide direction, planning and execution of the Clinical Pharmacology programs integrating novel translational biomarkers and quantitative modeling/simulation in the clinical development programs. The candidate is expected to be an active contributor to the cross-functional teams, providing innovative and progressive thinking to projects and where appropriate provide guidance to other team members. This person will be relied upon to act independently, within a matrixed clinical development organization and must have the experience and conviction to provide sound input to various project teams with regard to clinical pharmacology, translational and quantitative activities. The candidate must be self-motivated, able to work in cross-functional global teams and have a strong work ethic and integrity. Additionally, the incumbent must possess outstanding verbal and written communication skills and be able to build relationships and influence decision-making, while managing tight-timelines.
Additional responsibilities include but are not limited to:
* Driving the development and execution of the Clinical Pharmacology strategy for small and large molecules in drug development and delivering key components of the Clinical Development Plan.
* Providing scientific leadership on Clinical Pharmacology strategy and translational science to cross-functional project teams. Working with clinical development and/or program teams to achieve program goals and provide deliverables in approved timeframes.
* Designing and implementing Clinical Pharmacology studies that allow early go/no-go decisions, incorporate innovative clinical development strategies and support competitive drug labels. Leading the integration of modeling & simulation (PK/PD) and PGx activities in the Clinical Pharmacology programs.
* Serving as a Study Director/Clinical Pharmacology lead and driving the execution of the protocol concept to final report including interpretation of clinical data.
* Creating and maintaining internal and external networks to maintain cutting edge knowledge of Clinical Pharmacology approaches and to implement novel designs in the clinical trial.
* Representing and leading clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings, Type C, NDA meetings. Leading the resolution of clinical pharmacology queries from drug regulatory agencies and taking a lead role in writing and reviewing responses to regulatory queries.
* Providing recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the clinical and project teams and in regulatory documentation
* Maintaining extensive scientific awareness and presence in Clinical Pharmacology, Publishing multiple manuscripts and posters, and Presenting at Scientific Conferences and other scientific forums.
Job Requirements: * MD or PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, or other related field. * Associate Director: 5-7 years of relevant experience; Director: 7-10 years of experience in pharmaceutical or biotechnology industry with a broad and proven understanding of drug development. * Experience interacting with regulatory agencies including being directly involved in the review process. Must have been directly involved with successful major regulatory filings. * Expertise in providing CRO and consultant oversight. * Experience in neuroscience and translational science is not required but strongly preferred. Experience internal medicine, pediatric indications is also preferred. *Embrace and model EISAI core values. *Travel: Less than 20%
Here at Eisai, we are rewarded with highly competitive salaries, incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, and other great programs.
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, pregnancy, 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 from tblHiringOrgDefaults