Associate Director, Global Clinical Scientist (Cell Therapy)

Position Summary / Objective

Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials

Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision

Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership)

Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members

May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)

Position Responsibilities

Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members

Plan and lead the implementation all study startup/conduct/close-out activities as applicable

Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)

Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)

Site-facing activities such as training and serving as primary contact for clinical questions

Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team

Clinical data trend identification; provide trends and escalate questions to Medical Monitor

Develop clinical narrative plan; review clinical narratives

Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.

Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities

Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)

Collaborate and serve as primary liaison between external partners for scientific advice