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. The successful candidate will be responsible for serving as the subject matter expert for clinical development operations for the assigned program(s).
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
Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.