Director, Clinical Supply Chain Management

Company Overview:

Black Diamond Therapeutics is a next-wave cancer precision medicine company. Black Diamond is at the forefront of developing selective medicines for patients with genetically defined cancers driven by oncogenes activated by allosteric mutations. Leveraging its innovative mutation, allostery, and pharmacology (MAP) computational and discovery platform, Black Diamond is revolutionizing the field by uncovering novel ways to functionally assess the mutational landscape of individual oncogenes. This approach allows us to discover and validate new targets and develop highly selective therapeutics that offer new hope to cancer patients.

Scope:

Reporting to the Vice President of Operations, the Director of Clinical Supply Chain Management will play a crucial role in overseeing and optimizing the clinical supply chain processes to support the successful execution of Black Diamond Therapeutics' precision medicine programs. The Director will collaborate cross-functionally to ensure the availability and distribution of investigational medicinal products for clinical trials.

Key Responsibilities:

• Budget Planning: Take an active role in managing the clinical supply chain budget. Review and approve vendor invoices, ensuring alignment with the budget plan.
• Labeling, Packaging, and Distribution: Work closely with Technical Operations and Clinical Operations teams to ensure timely labeling, packaging, and distribution of clinical trial materials. Oversee the process to guarantee the availability of properly packaged and labeled investigational products for trials.
• Inventory Management: Establish and monitor an appropriate monthly forward inventory level to ensure continuity of supply throughout the trials. Advise Clinical Operations teams and study sites on inventory levels and collaborate with them to manage and optimize inventory.
• Process Optimization: Establish and optimize workflows and Standard Operating Procedures (SOPs) in line with industry best practices. Identify opportunities for process improvements to enhance efficiency, quality, and compliance. Drive improvements to ensure an efficient and accurate supply chain that can accommodate rapid growth and potential commercialization.
• Risk Management: Identify potential supply risks and proactively develop preventive actions to avoid any supply interruptions. Collaborate with cross-functional teams to implement risk mitigation strategies effectively.
• Vendor Collaboration: Collaborate closely with external vendors to develop and approve specifications and user acceptance testing of Interactive Voice Response (IVR) and Interactive Web Response (IWR) systems. Review and modify these systems as needed in response to study plan changes.
• Cross-Functional Collaboration: Collaborate effectively with cross-functional teams including Clinical Operations, Technical Operations, Regulatory Affairs, Quality Assurance, and Finance to ensure seamless alignment of clinical supply chain activities with budget, project timelines and regulatory requirements.
• Vendor Management: Oversee the management of vendors and their respective contracts, ensuring compliance with contractual obligations, quality standards, and timelines. Review vendor-generated documentation and collaborate with the Quality team for final review and approvals.
• Leadership and Development: Experience having led a product launch or at least been on the launch team to know what is needed.
• Forecasting and Demand Management: Develop and manage forecasts by creating comprehensive clinical supply demand plans for ongoing and upcoming clinical trials. Collaborate closely with Clinical Operations and Technical Operations teams to ensure accurate demand projections aligned with trial timelines and patient enrollment targets.

Qualifications:

·Minimum of 10 years of progressively responsible experience in clinical supply chain management or related roles. APICS certification or coursework is preferred

• Knowledge of US (United States), EU (European Union), and rest of the world clinical supply labeling requirements is required. Knowledge of QP review process for European clinical supplies is preferred
• Experience building a supply chain department that is efficient, phase appropriate and capable of supporting potential commercial product launch in a fast-paced industry.
• Strong project management skills and can manage multiple projects simultaneously while meeting deadlines and quality standards.
• Direct experience in planning and overseeing supply for double-blinded placebo-controlled, as well as open label clinical studies
• Experience with both ambient and cold chain products is required
• Knowledge of global practices governing pharmaceutical drug product manufacturing and conduct of routine clinical trials distribution.
• Onsite presence one day per week.
• Demonstrated experience in successfully managing complex vendor relationships, including contract negotiation and oversight.
• Experience with new product launch including global supply chain and serialization as per country requirements.