Apex Systems
Associate Director-Sr. CTM - Cell Therapy-Biologics
Apex Systems, Cambridge, Massachusetts, us, 02140
Associate Director-Sr. CTM - Cell Therapy-Biologics
Location:
Cambridge, MA (Hybrid)Science/ Focus:
Cell TherapyJob Overview:
This role will lead early-stage, global clinical trials, ensure high standards and efficiency, and manage vendor relationships.Primary Job Responsibilities:Oversee clinical trials, ensuring quality from start to finish.Enhance communication and workflow, ensuring risk management and accurate timelines.Act as the key contact for external partners, aligning internal and external expectations.Lead in developing trial documents and managing study dynamics for optimal outcomes.Primary Job Requirements:Bachelors in life sciences with 5-10+ years of clinical operations experience specifically with early-stage biotech.Biologics or cell therapy background with expertise in early-phase clinical trials and IND/CTA submissions.Proficient in clinical operations best practices and versed in GCP/ICH regulations with strong interpersonal skills.Independent, detail-oriented problem solver with a history of delivering quality outcomes.
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Location:
Cambridge, MA (Hybrid)Science/ Focus:
Cell TherapyJob Overview:
This role will lead early-stage, global clinical trials, ensure high standards and efficiency, and manage vendor relationships.Primary Job Responsibilities:Oversee clinical trials, ensuring quality from start to finish.Enhance communication and workflow, ensuring risk management and accurate timelines.Act as the key contact for external partners, aligning internal and external expectations.Lead in developing trial documents and managing study dynamics for optimal outcomes.Primary Job Requirements:Bachelors in life sciences with 5-10+ years of clinical operations experience specifically with early-stage biotech.Biologics or cell therapy background with expertise in early-phase clinical trials and IND/CTA submissions.Proficient in clinical operations best practices and versed in GCP/ICH regulations with strong interpersonal skills.Independent, detail-oriented problem solver with a history of delivering quality outcomes.
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