Associate Director, Clinical Development Operations

Location
Gaithersburg, MD
Posted
Oct 20, 2020
Required Education
Masters Degree/MBA
Position Type
Full time

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.

MAIN ACCOUNTABILITY:

  • 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

PREFERRED QUALIFICATIONS:

  • 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