Clinical Research Scientist - Neurology Business Group
Eisai - Woodcliff Lake, NJ
Employment Type : Full-Time
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 Description Summary:
The Senior Clinical Scientist will assist the Clinical Lead/Study Director/Medical Monitor in the planning, implementation, execution, and day to day management and reporting of assigned clinical trial activities with minimal to moderate level of supervision. Additional responsibilities include: Supporting the analysis of clinical trial data to support future development activities; assisting with the preparation of the clinical trial synopses, Protocols, protocol amendments, drug development plans, clinical research forms, Investigator Brochure, Clinical Study Report.; CRA training on protocol and processes; assisting with the preparation of clinical sections of Regulatory documents; assisting with database cleaning (eligibility listings, patient profiles, listings, laboratory results, etc.); and assist with the preparation of publications (abstracts, articles, etc.) pertinent to the study.
Position Responsibilities:
- Responsible for implementation, planning, and execution of assigned clinical trial activities.
- Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision
- May support clinical development planning (collaboration with Clinical Development Lead/Clinical Study Director for provision and analysis of data to support future planning)
- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting internal/external team members as necessary
- Support the implementation study startup/conduct/close-out activities as applicable
- Aids in design, execution, and oversight of clinical studies.
- Supports the scientific aspects of the implementation and conduct of a clinical trial (e.g., investigator meeting presentations, safety review and medical monitoring activities), in collaboration with the Clinical Lead/Study Director/Medical Monitor
- Ensures that clinical research program design meets scientific objectives. May serve as the scientific representative on the clinical study team.
- Lead protocol, protocol amendment, and ICF development with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (in collaboration with Medical Writing and the Study Team)
- Site-facing activities such as training and serving as primary contact for clinical questions as appropriate
- Participate in activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
- Monitor for clinical data trend identification in collaboration with Study Director and Medical Monitor.
- Review development of site and CRA training materials and presentations at SIV and Investigator meetings
- Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses) in collaboration with Clinical Lead/Study Director/Medical Monitor
- Collaborate and serve as primary liaison between external partners for scientific advice as appropriate
Essential Functions
Study Management:
- Assist the Clinical Lead and/or Study Director in the planning and implementation, execution, day to day managing and reporting of clinical trials
- Develops and reviews clinical study documents, including CRFs, ICFs, IRB/EC responses
- Assist with database cleaning (eligibility listings, patient profiles, listings, laboratory results, etc.)
Clinical Development Program:
- Develops Protocol Concept Sheets, Protocols, protocol amendments, drug development plans, clinical research forms, Investigator Brochure, Clinical Study Report, etc.
Clinical Research Expert:
- Contributes to risk resolution by monitoring clinical study data and escalating projects risks
- Makes recommendations for improving resources (tools, systems, vendors, etc.) needed by the team.
Education Requirements:
- Bachelor’s degree with 7+ years; or MS with 5+ years; or PhD with 2 years relevant career experience
- Degree in the Life Sciences or significant experience in clinical development (> 11 years)
- 5+ years of experience in clinical science, clinical research, or equivalent
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
- Knowledge of medical, scientific and clinical research techniques in assigned therapeutic area.
Required Experience and Skills:
- Pharmaceutical and/or clinical drug development experience.
- Excellent oral (including presentation) and written communication, computer/ database management and project management skills
Preferred Experience and Skills:
- Neuroscience experience, preferably in Neurodegenerative
• Ability to effectively communicate and collaborate across functions and job levels • Ability to assimilate technical information quickly
- Routinely takes initiative
- Strong sense of teamwork; ability to lead team activities
- Proficient in Medical Terminology and medical writing skills
- Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
- Proficient critical thinking, problem solving, decision making skills
- Adaptable / Flexible with ability to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
- Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review, or similar data reporting tools
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.