Director/Sr. Director, Oncology - China
Submitted by admin on Tue, 03/15/2011 - 16:57
Company: Eisai, Inc. /Eisai China, Inc.
Title: Director/Sr. Director, Oncology ¨C China
Reports to: US Senior Vice President, Clinical Development
Oncology Product Creation Unit (PCU)
Country: China: Shanghai or Beijing
A COMPREHENSIVE APPROACH TO CANCER THERAPY AND GROWING GLOBAL COMMITMENT NOW EXPANDS TO ASIA-PACIFIC REGION - Eisai¡¯s global commitment to oncology continues to grow and is now keenly focused on the emerging markets in China, Taiwan and Korea. We are seeking an individual that is a self starter and looking for the opportunity to bring energy and enthusiasm to expanding Eisai¡¯s oncology portfolio into this region.
Eisai is an agile, entrepreneurial organization managed by experienced leadership, backed by the strength, stability and historical successes of their parent company, Eisai Co., Ltd., Japan. Effective July 1, 2009 Eisai changed their approach to Research. They now approach Research with Entrepreneurial Product Creation Units (PCU¡¯s). Takashi Owa, PhD leads the Oncology Product Creation Unit and is responsible for the full cycle of development, from discovery through regulatory approval.
Position Summary: China has been identified by the Eisai CEO office as a major corporate priority. This is a newly created position responsible for establishing Eisai¡¯s oncology clinical studies in China, Taiwan and South Korea to speed the time to global registration into this region and to expand their development opportunities into the key countries of China Taiwan and South Korea. This physician will be the key interface with the local Eisai China Company (ECI), and the Asian operations unit in Singapore with responsibility for clinical oversight of oncology studies being conducted in Asian region (excluding Japan). The Director/Sr. Director will handle all aspects of running studies including writing protocols, identifying principal investigators and working with key opinion leaders in the region. Additionally the Director/Sr. Director will be working with Asian, US and EU regulatory bodies in order to conduct studies and prepare related documentation for submissions.
Eisai¡¯s oncology pipeline: 13 pipeline compounds that address cancer from multiple directions: targeted agents, cytotoxics, monoclonal antibodies, supportive care and therapeutic vaccines.
This position will be responsible for clinical development for all their oncology portfolios ranging across Phase I-III with initial accountability for:
¡¤ oral multitargeted tyrosine kinase inhibitor - E7080 ¨C Phase II heptocellular carcinoma cancer (HCC) program with focus in China, Korea and Taiwan.
¡¤ Eribulin Mesylate (E7389), a cytotoxic chemotherapy for the treatment of patients with solid malignancies including breast cancer and NSCLC. Eisai Inc. announced on 11/15/2010 that the United States Food and Drug Administration (FDA) has approved Halaven™ (eribulin mesylate) Injection for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.
¡¤ Ontak: Phase II study for melanoma.
Responsibilities:
¡¤ Assumes accountability for oncology/hematology programs
¡¤ Develops and implements medical aspects of clinical plans for oncology compounds
¡¤ Interact with clinical investigators and KOL to plan, initiate, and conduct clinical trials within China, Taiwan and South Korea
¡¤ Develop and/or review protocols for clinical trials.
¡¤ Monitor safety reports and implement appropriate pharmacovigilance actions, if necessary.
¡¤ Provide support for global regulatory reports.
¡¤ Defines therapeutic area function/project vision and strategy for achieving that vision, and engages and motivates team to buy into vision and execute strategy through clear and persuasive communication skills
¡¤ Contributes to Development results by providing therapeutic area leadership and assuming a supervisory and/or ¡°subject matter expert¡± role with regard to therapeutic area issues
¡¤ Brings external market perspectives and shares insight and knowledge regarding therapeutic areas with groups within own department and across Eisai as appropriate
¡¤ Ensures that the therapeutic area group has information required to achieve the group¡¯s business objectives
QUALIFICATION AND EXPERIENCE:
- Position requires Medical Degree. Prefer candidate to be a medically trained Oncologist.
- Must have 3 to 5 years clinical experience and 3 to 5 years pharmaceutical industry experience as clinical lead in Phase 1 ¨C 3 studies in China, Taiwan or Korea.
- Must be fluent in writing and speaking Chinese and English. Ideal candidate will also be familiar with speaking Japanese.
- Must have current experience working with FDA or EMEA and Asian regulatory agencies handling responses to inquires and requests for study related information.
- Prefer individual with broad experience and understanding of running clinical studies with experience in Clinical Operations, Data Management.
- Must be effective working independently (a self starter) and must also be effective influencing others and working closely and collaboratively with colleagues in Japan.
- Requires relocation to China.
For consideration contact:
Moira Newbanks
Vice President, Oncology
The Chase Group, Inc.
#913-696-6331
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