Manager, Pharmacy Services

Syst Immune is a leading and well-funded clinical-stage biopharmaceutical company located in Bothell, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). Syst Immune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. Syst Immune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development.

We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

Syst Immune is seeking a dedicated and detail-oriented Manager of Pharmacy Services to join our dynamic and growing clinical trials team in oncology. This role serves as the Pharmacy Services lead with responsibility for ancillary clinical supply strategy and site pharmacy support and collaborates with Clinical Supply Management on investigational product (IP) distribution activities. The primary focus of this position is to provide pharmacy operational expertise through pharmacy manual development, site pharmacy support, investigational product (IP) preparation, handling and administration guidance, and resolution of pharmacy-related study issues.

This position is critical in ensuring that pharmacy-related activities are conducted in compliance with regulatory requirements and study protocols.

• Manual Development: Develop, maintain, and update comprehensive pharmacy manuals for oncology clinical trials, including guidance on IP handling, storage, preparation, and administration procedures.
• Site Pharmacy Support: Serve as the pharmacy/site-facing point of contact for operational questions related to IP administration and the ancillary components necessary to support IP delivery. Provide ongoing pharmacy operational support to study sites and resolve pharmacy-related study issues.
• IP Preparation, Handling & Administration Guidance: Provide pharmacy expertise related to IP preparation, handling, storage, and administration to support consistent and protocol-compliant study execution.
• Ancillary Supply Strategy & Vendor Management: Lead global ancillary clinical supply sourcing, procurement, forecasting, distribution, and lifecycle management. Identify and qualify vendors capable of supplying study-specific ancillary materials required for investigational product preparation and administration. Manage relationships with ancillary supply vendors and distribution partners. Oversee ancillary supply inventories and distribution strategies to ensure uninterrupted site support. Collaborate with Clinical Supply Management and Clinical Operations to align ancillary supply plans with study enrollment and operational forecasts.
• IP Distribution
  
  Collaboration:
  
  Partner with Clinical Supply Management to support investigational product distribution activities, review site supply needs, troubleshoot supply issues, and provide pharmacy expertise related to investigational product administration.
• Regulatory Compliance: Ensure pharmacy manuals and pharmacy-related activities comply with applicable regulatory guidelines, Good Clinical Practice (GCP), study protocols, and institutional requirements.
• Cross-Functional Collaboration: Work closely with Clinical Supply Management, Clinical Operations, clinical project managers, CRAs, site pharmacists, study sites, and vendors to support pharmacy operations and study execution.
• Training: Provide training and support to pharmacy staff and relevant study teams on pharmacy manuals, IP preparation and administration requirements, ancillary supplies, and updates or changes.