Director Study Leader, Cell Therapy

The Director Study Manager, Cell Therapy supports the delivery of cell therapy clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the nature of the clinical program or study.

You Will:

• Contribute to the development of study documents and any updates/amendments, ensuring template and version compliance.

• Lead the preparation of country-specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.

• Manage the set-up of third-party vendors, assessing initial statement of work and budget and the change order process.

• Provide input to data management documents and interface with data management representatives and sites to help deliver study data.

• Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and help track spend against approved budget.

• Ensure the supply of study materials by partnering with external service providers.

• Oversight of third-party vendors, global / local internal staff, and investigator sites to support delivery of a study

• Provide oversight of and support study patient recruitment and data delivery and risk mitigation strategies.

• Support the clinical trial insurance process, track approvals, revisions, and renewals of certificates.

• Monitor study conduct and progress, identifying issues which may impact delivery of the study to the necessary quality, timelines, or budget.

• Support risk management and quality efforts to ensure study compliance.

• Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.

• Support the study team in the implementation of audits and regulatory inspections.

• Contribute to review of new/amended/unique SOPs and guidance documents.

• Ensure the supply of study materials and ensure the appropriate allocation of a pheresis/manufacturing slot availability by collaborating with Cell Therapy Operations (CTO) or external service providers.

You Have:

• University degree / Bachelor’s degree in medical or biological science, or discipline associated with Clinical Research, or equivalent experience

• Minimum of 3-4 years of clinical trial experience

• Bachelor’s Degree and 3+ years of experience, Associate’s degree plus7+ years of experience or High School plus 11+ years of experience• Experience working with and delivering through strategic partners and 3rd party vendors• Excellent knowledge of ICH-GCP principles• Team oriented coordinate and prioritize multiple tasks and deliverables• To achieving study goals • Demonstrated verbal and written communication skills• Some travel may be required

• Desired • Early phase oncology clinical trial experience• Experience in autologous or allogeneic therapies• Clinical Study Management experience

Our Benefits:

The annual base salary for this position ranges from $162,566 to 243,849.

However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

#celltherapy #LI-Onsite