PRIMARY OBJECTIVE: The candidate will bring a strong understanding and demonstrated expertise with leadership of clinical data management and successful CRO oversight. His/her functions will include but are not limited to oversight of outsourced clinical data management activities, development of clinical trial data management documents, and shaping further development of the data management function . The successful candidate will be responsible for serving as the subject matter expert for clinical data management 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 performance of vendors for outsourced functions
- Responsible for delivering actionable clinical data from assigned clinical program(s)
- Establishes metrics for data management, oversees vendor performance relative to expectations, and devises operational efficiencies where needed
- 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
- 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 data management in either a Sponsor or CRO organization
- 7 years of experience in a leadership role within clinical data management
- Experience overseeing CROs and/or other vendors on a clinical trial
- Experience with cell therapy clinical trials
- Experienced in hematologic malignancies and corresponding clinical data
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.