Senior Manager, Pharmacy Support Services

Role Summary

The Senior Manager, Pharmacy Support Services (PSS) serves as a high‑impact subject matter expert in investigational product (IP) management and pharmacy operations across our clinical portfolio. In this role, you will guide best practices for IP handling, preparation, and administration; develop high‑quality pharmacy documentation and training; and support global clinical sites to ensure safe, compliant, and streamlined trial execution. You will partner closely with Formulation Development Group (FDG), Clinical Operations, and CDSL leadership to shape strategy, improve processes, and directly influence the success of our trials.

• Act as the primary SME on investigational product preparation, administration, blinding, and pharmacy‑related ancillary supplies.
• Shape the development of pharmacy manuals, clinical study documents, and training materials supporting biologics and gene therapy programs.
• Partner with Clinical Operations, CROs, and site pharmacy teams to ensure IP readiness, compliance with regulatory requirements, and optimal preparation workflows.

• Lead or contribute to Kick‑Off Meetings, Site Initiation Visits, Investigator Meetings, and IP‑focused training for global clinical teams.
• Support the review and resolution of IP‑related deviations and practice‑based issues to maintain protocol integrity and patient safety.
• Manage ancillary supply compatibility assessments in collaboration with FDG.

• Provide guidance on IP‑related quality assurance issues and support risk mitigation strategies.
• Ensure adherence to GCP, ICH guidelines, and federal/international regulatory standards.
• Identify opportunities to enhance processes and elevate site experience through data‑driven improvements and feedback mechanisms.

• Create engaging training modules for internal teams, monitors, and research sites.
• Play a key role in onboarding new colleagues and fostering a culture of scientific excellence, collaboration, and shared knowledge.

• Expertise in sterile product preparation and infusion‑based drug administration
• Experience with biologics; cell and gene therapy exposure preferred
• Strong understanding of clinical supply chains and clinical trial execution
• Exceptional communication, documentation, and presentation skills
• Ability to manage complex projects and influence cross‑functional teams
• Adaptability, critical thinking, and a continuous‑improvement mindset
• Familiarity with PCAB, FDA, USP, NABP/VPP, and EU CTR guidelines
• Strong analytical, decision‑making, and problem‑solving capabilities

• In order to be considered qualified, a minimum of a bachelor’s degree in pharmacy or nursing with 8+ years of experience in hospital pharmacy, clinical research, or pharma/biotech. Or a Pharm
  
  D with 6+ years of experience in hospital pharmacy, clinical research, or pharma/biotech.