Overview
Founded in 2000, the WuXi AppTec Group is the leading global pharmaceutical, medical device open-access capability and technology platform company with more than 22,000 employees across 25 locations globally. The WuXi platform is enabling more than 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi AppTec Group’s dream that “every drug can be made and every disease can be treated.”
WuXi Oncology is a division of WuXi Clinical, dedicated to accelerating and transforming clinical research operations for our clients focused on Oncology clinical research.
Summary: The Director of Feasibility, WuXi Oncology, participates in the development of strategies for assigned clients, This role will manage feasibility proposals and reports for business development activities, strategies for country and site selection, budgets and project outcomes. The incumbent is responsible for conducting research and analysis of competitive intelligence, writing robust client proposals, and oversight of efficient operations. Will represent WuXi Oncology at bid defenses meetings. Oversees Investigator strategy and site coordination, will set priorities for workload and deliverables, and manage the feasibility process with stakeholders, including: Regulatory, Medical Affairs, Project Management and Clinical Operations.
Responsibilities
- Works with Medical Monitors and Clinical Operations leadership on trial conduct and protocol review
- Conducts research of patient populations, therapeutic areas and relevant clinical trials identifying regions of disease prominence across multiple oncology indications
- Budgetary responsibility for Feasibility function
- Process improvement of patient enrollment process
- Represent WuXi Oncology at global and regional events and attendance at client bid defenses
- Develops and delivers training for the Feasibility team
- Collaborate with Regulatory on strategy and timelines
Qualifications
- MS preferred, with a minimum of a BS degree, in a life sciences or health related discipline
- Minimum of 10-15+ years of demonstrated clinical research experience, including Feasibility experience of 7+ years within a global CRO organization
- Experience with Oncology clinical trials required
- Strong expertise in the preparation of feasibility proposals
- Familiarity with proprietary and government/international databases
- Strong QA experience in Feasibility operations
- Solid knowledge of FDA regulatory guidelines; knowledge of international regulatory guidelines highly desired
- Strong experience in the international standards affecting clinical trials (ICH, GCP, etc.)
- Exceptional communication and presentation skills, verbally and written, and ability to articulate ideas and vision clearly
- Demonstrated leadership experience, including fostering development, training and mentoring of staff
- Exceptional skills in leading projects and teams
- Demonstrates extreme professionalism, flexibility in a dynamic environment
- Travel – willingness to travel both domestically (US) and Overseas
Our Values:
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi Oncology provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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