Position Summary:

The Clinical Supply Chain Operations Lead will be responsible for overseeing the end-to-end clinical supply chain activities for our portfolio. This individual will work closely with cross-functional teams, including Clinical Development, Clinical Operations, CMC, Quality Assurance, and Regulatory, to ensure the timely and compliant supply of clinical trial materials (CTM). The ideal candidate is a proactive, solutions-oriented professional with a strong background in supply chain management within the biopharmaceutical industry, particularly with a focus on clinical trial supply operations.

Key Responsibilities:

• Strategic Supply Chain Planning: Develop and implement clinical supply chain strategies to support global clinical programs and trials, ensuring the availability of CTM at all clinical sites in a timely and cost-effective manner.
• Operational Oversight: Oversee clinical supply planning, including demand forecasting, inventory management, production scheduling, and distribution to ensure efficient and uninterrupted supply.
• Vendor Management: Lead selection, management, and maintenance of strong relationships with third-party vendors, including contract manufacturing organizations (CMOs), packagers, and distributors, to ensure alignment with project timelines and quality standards.
• Cross-functional Collaboration: Act as the primary liaison with internal stakeholders such as CMC, Clinical Operations, Regulatory, and Quality to align supply chain activities with clinical and regulatory requirements.
• Risk Management: Identify, mitigate, and manage risks associated with clinical supply chain activities, including forecasting errors, supply disruptions, and regulatory compliance risks.
• Compliance & Documentation: Ensure all supply chain activities comply with applicable regulatory requirements (e.g., GMP, GCP) maintain accurate records, and establish procedural documents (SOPs) and work instructions. This will include review of packaging and labeling records and initiation/contribution of/to change control and quality issues related to supply chain. Will support regulatory inspections and audits.
• Budget & Cost Control: Develop and manage budgets for clinical supply chain operations, ensuring efficient use of resources and adherence to financial targets.
• Process Improvement: Continuously evaluate and optimize supply chain processes, systems, and procedures to improve efficiency, scalability, and flexibility in supporting Scorpion's growing portfolio.

Qualifications:

• Education: Bachelor’s degree required; advanced degree preferred.
• Experience: 8+ years of experience in clinical supply chain operations, with at least 3 years in a leadership role within the biopharmaceutical or biotechnology industry. Global experience required, including direct experience working in Americas, EU, and APAC.
• Technical Expertise: In-depth knowledge of clinical trial supply chain requirements, including Good Distribution Practices (GDP), GMP, and GCP regulations, and experience managing clinical supply distribution in global markets.
• Project Management Skills: Proven ability to manage multiple projects simultaneously, with strong organizational and project management skills.
• Analytical Abilities: Strong problem-solving skills and the ability to analyze complex data sets for informed decision-making.
• Communication Skills: Excellent written and verbal communication skills, with the ability to interact effectively with stakeholders at all levels of the organization.
• Leadership Skills: Ability to lead and develop a high-performing team, fostering a collaborative and results-oriented culture.
• Technology Proficiency: Proficiency in supply chain management software and systems.