Director, Clinical Supplies

Role Summary

This position can be 100% remote, but must be located in the United States. The Director, Clinical Supplies is responsible for ensuring investigational medicinal product (IMP) is delivered on time and in alignment with clinical and project plans. This includes oversight of planning, forecasting, sourcing, packaging, labeling, distribution, and return of clinical materials for clinical studies and investigator-initiated research (IIR). This role is a key contributor to clinical development projects and works closely with cross-functional study teams, including Project Management, Technical Operations, Chemistry, Manufacturing and Controls (CMC), Clinical Operations, Regulatory Affairs and Quality.

Responsibilities

• Lead clinical supplies function, including direct reports if applicable, in the overall strategy and execution relating to management, packaging and labeling, forecasting, delivery, storage and accountability of investigational medicinal product (IMP) for Dynavax clinical trials and Investigator Initiated Research.
• Lead interactions with Regulatory, Quality Assurance (QA), and Clinical in the design and approval of labels for primary and secondary packaging to meet country-specific labeling requirements, including translation of required label text into appropriate languages.
• Ensure the clinical supplies operations meets GCP and GMP standards and internal benchmarks for quality and compliance. Lead or participate in initiatives to improve quality in any area related to clinical supplies.
• Provide Clinical with packaging options that best meet the needs of the clinical trial design.
• Update pharmacy manuals and other documentation and/or manuals as needed.
• Lead discussions with Clinical to determine the best supply strategy for efficient use of IMP and standard of care (SOC) medication. Balance project and corporate goals with expiry dates and study timing to ensure adequate, but not excessive, overages are employed in the supply strategy.
• In consultation with internal stakeholders, identify, evaluate, and select suitable vendors, both domestic and international, for packaging, labeling, and storage of IMP.
• Manage internal contracting process for onboarding selected vendors including but not limited to completion of purchase requests and contract review and execution.
• Contribute to the development of the operating plan by projecting clinical supply costs and long-range planning estimates. Responsible for generating and managing clinical supply cost estimates for each clinical study, including budget forecasting, accruals, re-projections, and scenario-based planning to support strategic decision-making and financial oversight.
• Effectively negotiate contracts with vendors and manage vendor adherence to contracts.
• Manage execution of packaging and labeling to ensure activities are performed according to cGMP, including technical review of master and executed batch records.
• Manage shipment of active pharmaceutical ingredients (APIs), drug substance, adjuvant, comparator product, and/or study-related devices to ensure timely delivery of materials to the appropriate drug product contract manufacturing organization and subsequent transfer of the drug product to the packaging and labeling vendor.
• Manage the clinical inventory of all manufactured materials, including API, drug substance, adjuvant, intermediate, and drug product.
• Effectively partner across functional lines to ensure timely release and shipment of IMP, placebo, diluent, and SOC to clinical sites.
• Manage product inventory through coordination with Clinical Operations to ensure adequate IMP, placebo, diluent, and SOC supply is available at the clinical sites for the duration of the clinical trial.
• In consultation with Clinical Operations, manage the final reconciliation of IMP at the close of each clinical trial.
• Ensure clinical supply documentation is submitted to the eTMF as appropriate. Participate in functional QC reviews of eTMF documentation as needed.
• Manage temperature-sensitive shipments and notify applicable stakeholders about issues and potential solutions in a timely manner.
• Monitor temperature excursion interactions to ensure appropriate reporting, management and disposition of materials, arranging for resupply, if necessary.
• Stay abreast of current US and international regulatory guidance on packaging and labeling requirements; interface with Regulatory for projects as needed.
• Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
• Work with cross-functional teams on long-range planning for clinical development programs.
• Other duties as assigned.

Qualifications

• Experience with contract management.
• Experience with management of cGMP manufacturing processes such as fill and finish and pre-filled syringes a plus.
• Able to work independently, as well as effectively within project teams, committees, etc.
• Proven track record with effective problem-solving and decision-making in a cross-functional team setting.
• Excellent organizational skills and the ability to work on multiple projects with tight deadlines, including the ability to effectively prioritize activities across projects.
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel both internally and outside the company.
• Excellent written and verbal communication skills.
• Analytical thinker with keen attention to detail.
• Effective leader who will work proactively to drive results.
• High level of integrity, flexible, action- and goal-oriented, collaborative and team-oriented.

Education

• BS or MS in life science

Additional Requirements

• Position may travel up to 25%.
• Ability to sit for prolonged periods; reach with arms and hands; lift and move small objects; use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands and/or fingers.