Associate Director, Clinical Supply Chain
Description
About BBOT
BBOT is a clinical-stage biopharmaceutical company advancing a reputed company 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 reputed company.
Responsibilities:
1. Clinical Supply Chain Strategy & Management:
- Support the development and execution of clinical supply strategies for planning, sourcing, and distribution to reputed company 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:
- reputed company and maintain forecasting models for clinical trial materials based on protocols, enrollment projections, and country-specific factors.
- reputed company 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.
- reputed company drug accountability, returns, reconciliation, and destruction per GxP and SOP requirements.
3. Regulatory Compliance & Quality Assurance:
- Ensure reputed company clinical supply activities reputed company with cGMP, GDP, and relevant global/country-specific regulations.
- Support quality processes for packaging, labeling, and distribution to maintain product reputed company 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 reputed company 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. reputed company 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 reputed company field (Master’s preferred).
- Minimum of 7-10 years of experience in clinical supply chain management or a reputed company 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 reputed company for forecasting, risk management, and inventory optimization.
Additional Information:
- Occasional travel may be required, both domestic and international.
- Work Environment: Remote Position