Senior Manager, Pharmacy Support Services Lead

4 weeks ago

Basking Ridge, New Jersey, United States BioSpace, Inc. Full time
Job Summary

The Senior Manager, Pharmacy Support Services Lead is responsible for driving activities related to Investigational Product used in the conduct of clinical research projects to ensure consistent deliverable of program objectives across our portfolio.

This role partners with Formulation Development Group (FDG), as a SME in investigational product handling, preparation, and administration.

The Senior Manager, Pharmacy Support Services Lead drives creation of documentation & training materials to ensure that best practices for IP management are upheld and looks for opportunities to improve the process.

This role focuses on clinical site research pharmacy support in compliance with applicable federal (CFR and ICH E6) and state regulations, international standards and regulations, good clinical practices, and institutional policies and procedures.

The Senior Manager, Pharmacy Support Services Lead provides consultation and lends expertise to Clinical Drug Supply & Logistics Organization (CDSL), the Formulation Development Group (FDG), the Clinical Trial Management Team (CTM), and partner groups on investigational products and medication/device related issues, such as aseptic IP preparation, concomitant medications, Instructions for Use (IFU), and patient compliance/adherence issues.

Key Responsibilities
  • Partners with the CDSL Managers, the Formulation Development Group (FDG), Regulatory Sciences (RS)/ Affairs (RA), as well as members of the Clinical Trial Management team (CTM) including the Clinical Study Lead (CSL), Study Medical Director (SMD) and Clinical Scientist (CS), Quality Management Lead (QML).
  • Provides consultation on various pharmaceutical aspects including site pharmacy operations as pertains to ancillary supplies, investigational product (IP) labeling & design, blinding issues, preparation, and administration of IPs for all REGN-funded/sponsored clinical trials.
  • Provides technical expertise for the development of clinical study documents and pharmacy manuals and will assist in development of admixture, dosing, and administration strategies for complex biologic products and gene therapies.
  • Collaborates with key partners to drive study activities including development of Pharmacy Manuals and associated forms, ensuring research site pharmacy requirements, and provides communication and coordination of pharmacy related activities.
Requirements
  • A minimum of a Bachelors Degree in Pharmacy or Nursing, or PharmD is required, and at least 8 years of relevant experience in Hospital or Clinical Research or equivalent pharmaceutical/biotech industry experience.
  • Strong understanding of drug product infusion via various route of administration.
  • Understanding of Clinical Supplies / Clinical Trial design.
  • Ability to effectively communicate across all levels; analytical problem-solving experience; must be able to develop and present varied and unique ideas; effective influence and negotiation skills.
  • Ability to build successful collaborations with internal and external partners; Must have strong communication skills; verbal, written, and presentation; Must have broad knowledge and cross-functional understanding of clinical trial methodology; Working knowledge of GCP and ICH principles.
  • Knowledge of PCAB, FDA, NABP/VPP, USP 795 & 797, EU CTR guidelines.

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