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