Manager, Pharmacy Services

SystImmune 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). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune 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.

Job Summary:

SystImmune 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.

Key Responsibilities:

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.

Quality Assurance & Documentation: Conduct regular reviews and updates of pharmacy manuals and maintain accurate records of pharmacy-related documentation, ancillary supply activities

Qualifications:

Education: Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or a related field. Advanced degree (PharmD, MS, or PhD) preferred.
Experience: Minimum of 5 years of experience in a clinical trial, oncology pharmacy, or related pharmacy services setting. Relevant backgrounds may include Clinical Trial Pharmacists, Pharmacy Operations Managers, site-level oncology pharmacists, Pharmacy Services professionals, and experienced Pharmacy Technicians with a strong clinical research background.
Knowledge: Strong understanding of clinical trial processes, oncology treatments, pharmacy operations, IP preparation and administration, ancillary clinical supplies, and applicable regulatory requirements.
Skills: Excellent written and verbal communication skills; strong attention to detail and organizational skills; ability to work independently and cross-functionally; proficiency in Microsoft Office Suite and other relevant software; and experience with clinical trial supply, ancillary supply sourcing/procurement, logistics, or vendor management.

Preferred Qualifications:

Experience developing and maintaining clinical trial pharmacy documentation and pharmacy manuals
Experience supporting site pharmacy operations in oncology clinical trials
Experience with global ancillary supply sourcing, procurement, forecasting, distribution, and vendor oversight; Certification in clinical research (e.g., ACRP, SOCRA) is a plus.
 
Benefits:
Competitive salary and benefits package.
Opportunities for professional development and career advancement.
Work in a dynamic and collaborative environment at the forefront of clinical research.
Contribute to meaningful projects that have the potential to improve patient outcomes and advance medical science.

The hiring pay range for this position is $120,000- $160,000 p er year based on skills, education, and experience relevant to the role.

SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
 
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
 
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.