Associate Director, Clinical Supply Chain

Description

About BBOT

BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit BBOTx.com.

Who You Are

This is an exciting opportunity for a highly motivated Associate Director, Clinical Supply Chain with a strong background in global clinical supply chain. We are looking for a talented and enthusiastic individual who thrives in a collaborative, fast-paced, and growing environment to join our team.

Responsibilities:

1. Clinical Supply Chain Strategy & Management:

- Support the development and execution of clinical supply strategies for planning, sourcing, and distribution to enable global clinical studies.

- Assist in sourcing commercial comparators, including due diligence support, documentation, vendor coordination, and ensuring compliance with country-specific sourcing regulations.

- Collaborate closely with the SVP, CMC, clinical development, and operations teams to align on supply needs, timelines, and resource requirements.

- Contribute to managing the end-to-end clinical supply chain process—from forecasting to delivery at clinical sites—ensuring compliance with protocols, international regulations, and trial timelines.

2. Inventory Management & Forecasting:

- Develop and maintain forecasting models for clinical trial materials based on protocols, enrollment projections, and country-specific factors.

- Lead IRT system setup, user acceptance testing (UAT), configuration, and ongoing maintenance for supply tracking and visibility.

- Monitor inventory levels, expiry dates, and batch traceability to maintain appropriate stock at sites and depots while minimizing waste.

- Identify potential supply risks and implement mitigation plans to avoid trial disruptions.

- Support resolution of supply chain issues impacting timelines and ensure continuity of supply.

- Assist in managing clinical supply budgets through cost-effective sourcing and distribution practices.

- Oversee drug accountability, returns, reconciliation, and destruction per GxP and SOP requirements.

3. Regulatory Compliance & Quality Assurance:

- Ensure all clinical supply activities comply with cGMP, GDP, and relevant global/country-specific regulations.

- Support quality processes for packaging, labeling, and distribution to maintain product integrity and regulatory standards.

- Partner with Quality Assurance to address deviations, temperature excursions, compliance issues, and audit preparation.

4. Stakeholder Communication & Cross-functional Collaboration:

- Act as a primary point of contact for clinical supply matters with internal stakeholders.

- Work collaboratively with clinical operations, regulatory, manufacturing, and other teams to align supply plans with trial needs.

- Provide regular status updates to senior leadership (including the SVP, CMC) on inventory, supply activities, and emerging risks.

5. Vendor and Contract Management:

- Manage day-to-day relationships with external vendors (e.g., manufacturers, packagers, logistics providers) to ensure compliant and on-time delivery.

- Support vendor selection, qualification, and performance monitoring.

- Ensure vendor activities meet GMP and regulatory standards.

- Assist in contract negotiation support and adherence to performance metrics and timelines.

6. Continuous Improvement:

- Contribute to process enhancements in clinical supply chain operations by implementing best practices and driving efficiency gains.

Requirements

Qualifications:

• Bachelor's degree in Supply Chain Management, Life Sciences, or related field (Master’s preferred).
• Minimum of 7-10 years of experience in clinical supply chain management or a related field, with at least 2-4 years in a leadership or senior role.
• In-depth knowledge of clinical trial operations, cGMP/GDP regulations, and global clinical supply chain best practices.

Skills:

• Strong negotiation, vendor management, and contract coordination skills.
• Outstanding communication, interpersonal, and leadership skills.
• Proven cross-functional collaboration and ability to manage multiple priorities in a fast-paced environment.
• Analytical mindset for forecasting, risk management, and inventory optimization.

Additional Information:

• Occasional travel may be required, both domestic and international.
• Work Environment: Remote Position