About the Role
We are seeking a talented and motivated Manager, Clinical Supply to join Secura Bio. The ideal candidate will lead the planning, execution, and oversight of clinical supply activities supporting global clinical development programs. The role is responsible for ensuring reliable product supply, coordinating cross-functional activities, and maintaining operational readiness across internal teams and external partners.
This role requires a high degree of ownership, responsiveness, and independent decision-making. The successful candidate will serve as a key liaison among Clinical Operations, Quality Assurance, Regulatory Affairs, contract manufacturers, depots, packaging vendors, and logistics providers. They will be expected to proactively identify and mitigate risks, communicate issues and priorities in a timely manner, and ensure continuity of clinical supply operations through effective planning and execution.
Employment Type
Full-time
Reports To
Senior Director, Technical Operations
Key Responsibilities
- Lead end-to-end clinical supply planning and execution for assigned clinical programs to ensure uninterrupted product availability throughout all phases of study conduct.
- Develop and maintain clinical supply strategies, including forecasting, inventory planning, manufacturing, packaging, distribution, and contingency planning.
- Serve as the primary owner and point of accountability for clinical supply activities, ensuring deliverables, milestones, and commitments are executed on time and to a high standard.
- Proactively identify, communicate, and mitigate supply chain risks that could impact study timelines, product availability, regulatory compliance, or operational execution.
- Act as the primary liaison among Clinical Operations, Quality Assurance, Regulatory Affairs, Finance, contract manufacturers, packaging vendors, depots, and distribution partners to ensure alignment and timely execution of supply activities.
- Provide effective oversight of contract manufacturers, vendors, and logistics providers, driving issue resolution, accountability, and continuous improvement.
- Maintain timely and effective communication with internal and external stakeholders, including routine status updates, issue escalation, and management reporting.
- Manage domestic and international clinical supply logistics and distribution activities, ensuring compliance with applicable regulatory and quality requirements.
- Support clinical supply budgeting, forecasting, inventory optimization, and strategic planning activities.
- Support Quality System activities related to clinical supply operations, including change controls, investigations, documentation, inspections, and continuous improvement initiatives.
Required Qualifications
- Bachelor's degree in Life Sciences, Supply Chain, Engineering, Business, or a related discipline, or equivalent combination of education and experience.
- Minimum five (5) years of experience in clinical supply chain, pharmaceutical manufacturing, CMC operations, or related pharmaceutical operations.
- Demonstrated experience developing and executing clinical supply strategies, including forecasting, inventory management, manufacturing planning, packaging, distribution, and vendor management.
- Strong knowledge of pharmaceutical manufacturing, clinical supply chain operations, cGMP requirements, GDP principles, and applicable regulatory requirements.
- Proven ability to independently manage multiple complex projects, drive execution of deliverables, and maintain accountability for results in a fast-paced environment.
- Demonstrated ability to proactively identify risks, develop mitigation strategies, and effectively communicate and escalate issues to stakeholders and management.
- Excellent communication, stakeholder management, and cross-functional leadership skills, with the ability to influence internal teams and external partners to achieve business objectives.
Preferred Qualifications
- Experience leading clinical supply operations for global Phase II and Phase III clinical studies.
- Experience working in a small or emerging biotechnology company environment with a high degree of independence and accountability.
- Experience managing external contract manufacturers, packaging vendors, depots, IRT providers, and global logistics partners.
- Knowledge of clinical supply systems and tools, including IRT/RTSM platforms, inventory management systems, serialization technologies, and clinical trial logistics processes.
- Demonstrated ability to utilize digital tools, data analytics, automation, and artificial intelligence solutions to improve planning, forecasting, reporting, communication, and operational efficiency.
- Project Management Professional (PMP), APICS/ASCM, Supply Chain, or related professional certification preferred.
Salary
Secura Bio was established in 2019 with a singular mission: to close the gap between innovative oncology therapies and the patients who need them most. Our high-touch approach is informed by our decades of experience shaping the impact of oncology’s largest clinical and market opportunities. We know that true impact comes from personalization and an unwavering commitment to serve patients and expand the possibilities of life-prolonging oncology medicines.