Position Summary:
We are seeking a strategic and experienced Director of Outsourcing to lead and manage external partnerships with Contract Development and Manufacturing Organizations (CDMOs) and clinical trial sites for our cutting-edge cell therapy programs. This role is critical to ensuring the timely, cost-effective, and compliant execution of manufacturing and clinical operations through external partners.
Key Responsibilities:
Strategic Outsourcing & Vendor Management
- Develop and execute outsourcing strategies for cell therapy manufacturing and clinical operations.
- Identify, evaluate, and select CDMOs and clinical sites aligned with program needs and regulatory requirements.
- Lead contract negotiations, including MSAs, SOWs, and quality agreements.
- Build and maintain strong, collaborative relationships with external partners.
Operational Oversight
- Oversee day-to-day performance of CDMOs and clinical sites to ensure adherence to timelines, budgets, and quality standards.
- Monitor KPIs and implement performance improvement plans as needed.
- Serve as the primary point of contact for issue resolution and escalation.
Cross-Functional Leadership
- Collaborate with internal teams including Process Development, Quality, Regulatory, Clinical Operations, and Supply Chain.
- Support tech transfer, scale-up, and validation activities at CDMOs.
- Ensure alignment between clinical development timelines and manufacturing readiness.
Compliance & Risk Management
- Ensure all outsourced activities comply with GxP, regulatory, and company standards.
- Proactively identify and mitigate risks related to outsourcing and vendor performance.
Qualifications:
- Advanced degree in Life Sciences, Engineering, or related field (PhD, MS, or MBA preferred).
- 10+ years of experience in the biopharmaceutical industry, with at least 5 years in outsourcing/vendor management.
- Deep understanding of cell therapy manufacturing, GMP operations, and clinical trial execution.
- Proven track record managing CDMOs and clinical sites in a global environment.
- Strong negotiation, project management, and cross-functional leadership skills.
- Excellent communication and interpersonal abilities.
Preferred Experience:
- Experience with autologous and/or allogeneic cell therapies.
- Familiarity with regulatory requirements in the US, EU, and other major markets.
- Experience in a fast-paced, high-growth biotech or pharma environment.