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 Vice President, Clinical Research Oncology is responsible for leading the clinical research function for early phase development programs within the Oncology business group. This position will have responsibility and accountability for the clinical development strategy of the respective compounds and will oversee the clinical execution of the associated clinical programs conducted globally. The VP Clinical Research will champion transformational business changes that deliver sustainable outcomes and long-term success, leading and cultivating cross-functional partnerships with key internal stakeholders. The incumbent is expected to be a member of strategic internal and external facing committees and will play a key role in creating clinical & scientific synergies at Eisai. Additionally, this position will need to collaborate effectively with internal and external stakeholders including development partners, opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase II and Phase III studies and prepare related documentation for submissions.This position will lead the oncology early phase clinical research team with approximately 8-10 MD's or PhD's, reporting to this role. The position reports to the EVP, CCLO of the Oncology Business Group at Eisai and will establish a close collaborative working partnerships with Eisai Discovery sites and late phase clinical development leaders.Essential Functions - Leading clinical strategy and executive of key business objectives and projects within the Early Phase oncology group.
- Participation in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect.
- Decision making that can impact overall clinical programs and business goals. Individual will be a full member of CCLO Leadership Team and on occasion represent CCLO at internal/external stakeholder meetings.
- Strategic thinking and the ability to problem-solve complex clinical research problems in which analysis of situations or data requires an in-depth evaluation of various factors.
- Analyzing gaps in current work processes and recommending enhancements.
- Exercising judgment and discretion on a consistent basis within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Interacting with other professionals and internal customers and externally, with peers in other biopharmaceutical companies, federal officials, external customers, vendors, regulatory authorities, etc.
- Expert advisor to CCLO and senior leadership on emerging advances in oncology and innovative study design.
- Leading and supervising a team of professionals or may lead teams within a project setting.
- Designing and providing oversight of clinical programs to include integrated clinical, regulatory, biomarker strategies, in close collaboration with Eisai Discovery sites and late phase clinical development leaders. Also includes input and oversight of business cases, in collaboration with strategic marketing functions.
- Participate and provide clinical leadership in department review and milestone committees and strategic meetings
- Direct program level leadership and oversight of clinical development plans for developmental compounds
- Overseeing and resolving operations aspects of clinical studies in conjunction with project and study teams and in accordance with Eisai SOPs, GCP and regional regulations.
Requirements - Medical Degree required (MD or MD/PhD), medically trained with a solid knowledge of both early and late stage development clinical development is required.
- Minimum 10 years (depending on prior scope of work and achievements) successful track record of pharmaceutical industry clinical development experience within Oncology with knowledge and experience in translational, Phase I, II, and III studies.
- Demonstrated competence as Study Director (or equivalent role) with Global Clinical Lead or Clinical Program Director accountability.
- Experience managing clinical development professionals (physicians, and non-physician employees) across various line functions is essential. Candidates should have strong clinical/project leadership background in a matrix environment having prior experience with a regulatory submission.
- Must have experience working with FDA or EMEA regulatory agencies handling responses to inquiries and requests for study related information.
- Candidates with broad experience and understanding of implementation and execution of clinical studies with exposure to and understanding of Clinical Operations and Data Management are required.
- Demonstrated global development background necessary and confidence to work in a multicultural matrix environment. Must be effective working independently (a self-starter) and must also be effective influencing others and working closely and collaboratively with colleagues in Europe and Japan. Influencing without authority is important.
- Innovative and inquisitive with a hands-on, practical approach to achieving deliverables.
- Travel percentage: Approximately 20-30%, domestic and internationally.
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: Right To Work  |
