Manager, Clinical Supplies
Responsible for ensuring the clinical supplies required for assigned clinical studies are provided per the project timeline and in accordance with applicable regulatory requirements. This includes management and oversight of the planning, forecasting, sourcing, packaging, labeling, distribution and return of clinical supplies. The successful applicant will collaborate closely as a member of cross-functional study teams that include Project Management, Clinical Operations, Regulatory and Quality. Reports to Director, Clinical Supplies.
- Develop study specific Global Product Supply Plans, contribute to Pharmacy Manuals and supply related training/instructional materials
- Manage supply planning/forecasting to ensure alignment with study activity and timelines
- Monitor inventory levels at sites through the life of a trial proactively avoiding potential issues
- Coordinate procurement, temperature excursions, product complaints and ensure expiry extensions are provided to depot/sites as needed to support continued use
- Collaborate with study team and vendors to assure proper distribution of supplies to study sites
- Manage return and destruction of clinical supplies, with proper documentation of all steps
- Serve as primary point of contact for third party packaging, distribution, and storage vendors
- Manage approval of the packaging and logistics service agreements and study specific plans
- Design/review/coordinate approval of investigational supply label text and proofs to meet specific country language(s), translations and regulatory requirements
- Liaise with appropriate parties to ensure adequate clinical study supply releases are obtained per applicable regulations (Qualified Person Release, Certificates of Analysis/Compliance, etc.)
- Work with cross-functional team to develop study-specific IXRS specifications and requirements documents providing IP management perspective
- Perform unblinded monitoring of IXRS inventory and functionality monitoring to assure resupply generation, etc. occur within defined specifications
- Bachelor’s degree, preferably in a scientific discipline; a combination of relevant education and applicable job experience may be considered.
- 5+ years global clinical supplies experience
- Thorough knowledge of GMPs, GCPs, ICH Guidelines
- Experience with IRT System design, implementation, user testing and monitoring
- Vendor management experience
- Ability to establish and meet multiple concurrent priorities and deadlines
- Willingness and ability to travel domestically and internationally as needed (~10%)
- Effective organizational skills, verbal and written communication, ability to present in group settings, commitment to quality, and the ability to think critically and creatively
The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.
Cidara Therapeutics is an E-Verify Company