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Secura Bio

Commercializes oncology therapies and develops COPIKTRA

Manager, Clinical Supply

Supply Chain ManagementUpdated on Nov 11
Full-timeRemote in USA$114k - $140kRemote

About the Job

Requirements

  • A bachelor's degree in Life Sciences, Supply Chain, Engineering, Business, or a related discipline, or an equivalent combination of education and experience.
  • At least five years of experience in clinical supply chain, pharmaceutical manufacturing, CMC operations, or related pharmaceutical operations.
  • Experience developing and executing clinical supply strategies, including forecasting, inventory management, manufacturing planning, packaging, distribution, and vendor management.
  • Knowledge of pharmaceutical manufacturing, clinical supply chain operations, current Good Manufacturing Practice requirements, Good Distribution Practice principles, and applicable regulatory requirements.
  • Ability to independently manage multiple complex projects, drive execution of deliverables, and maintain accountability for results in a fast-paced environment.
  • Ability to identify risks, develop mitigation strategies, and communicate and escalate issues to stakeholders and management.
  • Communication, stakeholder management, and cross-functional leadership skills, including the ability to influence internal teams and external partners.

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.
  • 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 oversight of contract manufacturers, vendors, and logistics providers, driving issue resolution, accountability, and continuous improvement.
  • Maintain timely 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.

Desired 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, Interactive Response Technology providers, and global logistics partners.
  • Knowledge of clinical supply systems and tools, including Interactive Response Technology/Randomization and Trial Supply Management platforms, inventory management systems, serialization technologies, and clinical trial logistics processes.
  • Ability to use digital tools, data analytics, automation, and artificial intelligence solutions to improve planning, forecasting, reporting, communication, and operational efficiency.
  • Project Management Professional, APICS/ASCM, Supply Chain, or related professional certification.

About the Company

Secura Bio

Commercializes oncology therapies and develops COPIKTRA

Secura Bio is an integrated biopharmaceutical company focused on bringing oncology therapies to patients. Its main product is COPIKTRA (duvelisib), an oral PI3K inhibitor used to treat adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The company is also running a Phase 3 study of COPIKTRA for relapsed or refractory nodal T-follicular helper cell lymphoma. Secura Bio’s approach centers on acquiring, developing, and commercializing approved and late-stage oncology assets, with headquarters in Las Vegas and a European office in Dublin. In simple terms, the company buys or develops cancer drugs and then brings them to doctors and patients who need them. Its goal is to close the gap between available oncology therapies and the patients who can benefit from them.

Company size
51-200
Company stage
Late Stage VC
Total funding
$55M
Headquarters
Berkeley Heights, NJ
Founded
2019

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