Senior Director, Translational Medicine
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.
Eisai is searching for a creative, resourceful, integrative thinker to lead Translational Science research through designing and executing Clinical Biomarker activities to support the development of innovative drugs in the neuroscience portfolio. We are seeking a Sr. Director, within the Clinical Pharmacology and Translational Medicine, with a strong scientific background in neurodegenerative diseases. They should have a strong track record in developing and implementing clinical translational research strategies across the neurology pipeline with a strong focus on Alzheimer’s Disease (AD). The qualified candidate will work closely with the Discovery Research, Clinical Development, and Clinical Operations groups to direct the translation of preclinical research into clinical applications, to develop, validate and implement biomarkers and pharmacodynamic and mechanism assays in neurodegenerative disease programs. The successful candidate will have the skills associated with the development and approvals in the drug and diagnostic space. This role embraces the principles of a translational medicine mindset, with a focus on operational excellence and deep scientific rigor. The ideal candidate will have a passionate desire to help transform current treatment paradigms for neurodegenerative diseases while working in an innovative and fast-paced environment.
Additional responsibilities include but are not limited to:
- Lead the design of biomarker strategy for clinical studies in neurology programs with attention to pharmacokinetics, pharmacodynamics, proof of mechanism, and patient selection.
- Responsible for the biomarker aspects of clinical protocol design and writing, as well as authoring the biomarker sections of Investigator Brochures, Clinical Study Protocols, and Reports, program documents, regulatory submissions and responses.
- Oversee the development and monitor the quality of pharmacokinetic, pharmacodynamic, and patient stratification biomarker assays to support the advancement of preclinical programs into the clinic.
- Oversee the design and implementation of biomarker analysis in clinical trials, ensuring operational execution by partnering with biomarker labs and data management according to cGCP guidelines.
- Co-author, assist and support the development of publications, abstracts, and presentations.
- Maintain up-to-date knowledge of scientific and clinical published literature in neurodegenerative disease biology and the competitive landscape.
- Establish biomarker analysis plans in collaboration with data scientists, biostatisticians and biomarker laboratories to ensure delivery of high-quality data to support analysis, interpretation, and reports of clinical biomarkers for internal decision-making and Health Authority submissions.
- Identify, contract with, and oversee external vendors to implement, validate, and conduct clinical biomarker assay development.
- Exhibit timely management and delivery of projects/workstreams within the agreed budget
- Ensure efficient implementation of all key deliverables and provides frequent project status updates to the cross-functional development teams
- PhD (or MD) in Molecular Biology or other related field.
- Senior Director: 10-12 years of relevant experience in pharmaceutical or biotechnology industry with a broad and proven understanding of drug development.
- Strong publication record demonstrating relevant experience in clinical trials, early drug development, drug discovery or biomarkers. Experience in neuroscience and translational science is strongly preferred.
- Must have experience coordinating biomarker research with a global clinical trial management team and providing CRO and consultant oversight.
- Experience interacting with regulatory agencies including being directly involved in the review process.
- Embrace and model EISAI core values.
- Travel: Less than 20%
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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