Associate Director, Clinical Supplies
Provides strategic and operational cross-functional leadership of all aspects of clinical trial material supply. Actively manages the forecasting, planning, scheduling, coordination, packaging and distribution of clinical supplies for multiple global projects. Directs material schedules, generates budgets, plans and coordinates the efficient movement of clinical trial materials through the development and execution of operational strategies for the designated programs. Reports to VP, CMC.
- Develops and maintains forecast models and budget for supplying clinical studies through study completion.
- Collaborates across the company in the evaluation and selection of clinical packagers, labelers, and distributors worldwide to ensure the timely supply of clinical trial material to enrolled sites.
- Manages CROs for clinical packaging/depot. Works in collaboration with the Clinical team to draft the clinical supplies section for protocols, to develop the clinical supplies plan and to create clinical packaging and labels.
- Responsible to develop, implement, and maintain IVRS in collaboration with Clinical Manager.
- Determines requirements for randomization and material codes and ensures the packaged drug products are consistent with the code assignments.
- Prepares, plans and obtains internal approvals to implement labeling and packaging in a cost efficient and timely manner to ensure supply of released, packaged products for clinical use. Works with Regulatory to define label contents and text (English, translated languages) for clinical supplies. Works with Quality to ensure supplies are prepared in compliance with cGMP and GCP regulations that meet US and global regulations.
- Ensures budgets, schedules and performance requirements are met. Works closely with accounting to review and approve invoices, and works closely with suppliers when invoices are disputed. Ensures timely review and disposition of suppliers’ invoices.
- Manages Purchase Orders and monitors supplier’s performance against each contract, including cost tracking for each PO/contract. Ensures each clinical packaging and distribution project is managed within budget.
- Coordinates the day-to-day fulfillment of drug shipment requests for all products under clinical development in a cost effective manner and in compliance with cGMP and GCP requirements.
- In collaboration with colleagues, understands product stability data and defines acceptable practices and procedures for handling any excursions or deviations from recommended storage and handling conditions. Point person to receive reports of excursions or deviations which may occur during shipment, handling, and storage of products. Resolves excursions or deviations in collaboration with Quality and defines and implements corrective/preventive actions to minimize future occurrence.
- Establishes and maintains a tracking system to document the genealogy and detailed usage history of all drug lots for each clinical trial.
- Manages the return and destruction of drug product in accordance with GMP regulations.
- Works with Regulatory to provide clinical supply information for INDs, IMPDs, NDAs, WMAs and ARs and provides input to other documents as necessary.
- Responsible for developing Pharmacy Manuals and associated training materials in coordination with appropriate stake holders.
- Develops appropriate clinical trial material blinding schemes to meet the needs of the clinical protocol.
- Manages comparators for clinical trials, including the development of a strategy for blinding; the manufacture, labelling and clinical packaging of blinded comparator supplies; and the manufacture, labelling, and clinical packaging of placebo supplies.
- In conjunction with Clinical, manages Pharmacy monitors.
- Bachelor’s Degree in engineering, science or business; a combination of relevant education and applicable job experience may be considered.
- 10 years of progressive experience in a clinical supply chain organization within the pharmaceutical industry and at least 5 years in a leadership position.
- Knowledge and understanding of areas impacting clinical supply management and the supply chain such as finance, quality, regulatory, and manufacturing.
- Thorough experience and familiarity with cGMP practices and knowledge of FDA CFR, ICH Annex 13 guidelines for storage, handling, and distribution of drug products.
- Experience developing and maintaining IVRS systems.
- Knowledgeable in global import/export logistics and regulations.
- Strong initiative, highly motivated, and able to work in a fast-paced, dynamic environment.
- Ability to organize and assimilate data/information, to prepare contingency plans and future strategies; to be proactive; to initiate continuous improvement projects.
- Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences.
- Ability to travel up to 10% domestically and internationally as needed.
- Advanced degree.
- Demonstrated ability to build a successful operational organization.
- Sustained track record of achievement.
- Experience in launching and commercializing new products.
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 EEO/AA/Disability/Vets Employer and an E-Verify Company