Associate Director, Clinical Development Operations
PRIMARY OBJECTIVE: The candidate will bring a strong understanding and demonstrated expertise with leadership of clinical development operations and successful CRO oversight. His/her functions will include but are not limited to operational and financial forecasting, oversight of outsourced activities, development of clinical trial documents, and executing clinical trials.
ABOUT ARCELLX: Arcellx (http://www.arcellx.com/) is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company is located in Gaithersburg, Maryland and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.
- Oversees selection, contracting, and budget-related activities for vendors and clinical trial sites
- Oversees performance of vendors for outsourced functions
- Provides strategic, tactical and operational input to cross functional team
- Translates development goals into relevant, tangible and measurable objectives for the clinical development team and drives optimal delivery
- Oversees and coordinates all budgetary activities for assigned programs including project budget creation, forecasting, accruals reporting and invoice approval
- Engages key stakeholders to ensure expectations of clinical development operations are being met or exceeded
- Bachelor’s degree required, Master’s Degree or greater preferred
- 12+ years of experience in oncology clinical development operations in a Sponsor or CRO organization
- 7 years of experience in a leadership role within clinical development operations
- Experience overseeing CROs and/or other vendors on a clinical trial
- Experience with cell therapy clinical trials
- Experience with financial forecasting and budget management
- Experienced in either early or late phase/pivotal trials