Senior Director, Clinical Trial Supply

Senior Director, Clinical Trial Supply reports directly to VP, Clinical Operations Oncology. Managing clinical trial supplies for assigned studies as Senior Director, Clinical Trial Supply; ensures compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), relevant standard operating procedures (SOPs), and regulatory requirements.

Key Responsibilities

• Responsible for all aspects of the Clinical Trial Supply Chain from CMOs to clinical sites (Phase 1-3) in accordance with regulatory, cGMP and cGDP requirements
• Responsible for participating in trial team meetings
• Planning and forecasting of supplies in collaboration with internal stakeholders e.g. CMC, Trial Management, Regulatory Affairs
• Oversight, coordination, and collaboration with subcontractors and CMOs to ensure delivery of IMP and related materials at the right time and quality level
• Reviewing and approving documentation from subcontractors and CMOs
• IRT system user as well as reviewing and approving URS and UAT
• Preparing and reviewing internal SOPs, deviations, complaints and CAPAs
• Responsible for reporting to and involving line manager in any time critical and quality issues occurring during the setup phase and/or during trial conduct
• Responsible for supporting QA in any relevant matter during conduct of the clinical trials
• Responsible for supporting other CTS teams as applicable
• Planning, sourcing, preparing, surveillance and facilitating of IMP and related materials for clinical trials (Incl. production, storage, distribution, monitoring, accountability, handling of returns and maintaining of PSF)
• Elaboration and review of label text in accordance with regulatory requirements
• Elaboration of pharmacy manuals and other documents relevant to clinical trials
• Elaboration and review of internal documentation (Protocol, instructions, manuals, e.g.) used in the conduct of the clinical trials
• Participation and collaboration in internal and external teams as relevant for the clinical trials and related activities

• Planning, sourcing, preparing, surveillance and facilitating of IMP and related materials for clinical trials (Incl. production, storage, distribution, monitoring, accountability, handling of returns and maintaining of PSF)
• Elaboration and review of label text in accordance with regulatory requirements
• Elaboration of pharmacy manuals and other documents relevant to clinical trials
• Elaboration and review of internal documentation (Protocol, instructions, manuals, e.g.) used in the conduct of the clinical trials
• Participation and collaboration in internal and external teams as relevant for the clinical trials and related activities

Requirements

• Master’s Degree, Bachelor’s Degree (or equivalent) level of qualification in Pharmacy, Life Sciences, Medicine, Nursing or related field equivalent
• 15+ years of experience from a similar position a pharmaceutical, biotechnology company or contract research organization (CRO) in clinical trial supplies management
• Strong knowledge of Good Manufacturing Practices, Good Distribution Practices, Good Clinical Practice and ICH guidelines, and other applicable regulatory requirements
• Strong organizational skills
• Strong ability to manage time and work independently
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade
• Ability to travel up to 20% of the time domestically and internationally

Estimated compensation: 240-260K/year

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance