Job Description
Our client is focused on the discovery and development of novel and differentiated therapeutic products, to address high unmet needs amongst various targeted patient populations. Their strategy will be to leverage an asset-rich in-licensing environment, with a focus on areas of high unmet need, utilizing a team with a strong track record of execution in immunology, inflammation, fibrosis and oncology.
The Clinical Supply Manager will be responsible for insuring the clinical supplies needed for assigned clinical studies are provided on time and in accordance with protocol and applicable regulatory requirements. This includes management and oversight of the full clinical supply lifecycle: planning, forecasting, sourcing, packaging, labeling, distribution, return, and destruction. The successful applicant will collaborate closely as a member of cross-functional study teams that include CMC, Project Management, Clinical Operations, and RA/QA.
Job Spec
- Develop study specific Investigational Product Supply Plans and contribute to Pharmacy Manuals and supply related training/instructional materials
- Manage supply planning/forecasting in collaboration with other GMP-supporting functional lines (e.g. Product Development, Analytical, QA, RA) to ensure alignment with study activity and timelines
- Design/review/coordinate approval of investigational supply label text and proofs to meet specific country language(s), translations and regulatory requirements
- Provide packaging campaign requirements to vendors & approve associated GMP records with QA
- Liaise with appropriate parties to ensure adequate clinical study supply releases are obtained per applicable regulations (Qualified Person Release, Certificates of Analysis/Compliance, etc.)
- Collaborate with study team and vendors to assure proper distribution of supplies to study sites
- Monitor inventory levels at sites through the life of a trial proactively avoiding potential issues
- Identify supply accountability tracking and ensure Master, Pharmacy, Subject Logs are appropriate
- Address temperature excursions, product complaints and ensure expiry extensions are provided to depot/sites as needed to support continued use
- Manage return and destruction of clinical supplies, with proper documentation of all steps
- Ensure appropriate documentation of IP supply activities is provided to the Trial Master File
- Work with cross-functional team to develop study-specific IRT specifications and requirements documents providing IP management perspective
- Perform un-blinded monitoring of IRT inventory and functionality monitoring to assure resupply generation, etc. occur within defined specifications
Person Spec
- Bachelor’s Degree in health or life sciences or equivalent with 5-7+ years’ experience in the pharmaceutical/ biotechnology industry and 3 years of international clinical supply experience
- Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives
- Experience with Interactive Voice/Web Response System (IXRS) design, implementation, user testing and monitoring
- Proficiency in Microsoft applications, collaborative platforms (e.g., SharePoint, eRooms, Drop Box, Skype for Business), Electronic Data Capture systems, and Inventory Management systems
- Ability to establish and meet multiple concurrent priorities and deadlines
- Willingness and ability to travel domestically and internationally as needed
- Effective organizational skills, verbal and written communication, ability to present in group settings, commitment to quality, and the ability to think critically and creatively
Cv to gerry@rftgroup.ie