Associate Director - Clinical Supply Chain

Description of Role

Centessa is currently seeking an (Associate) Director, Clinical Supply Chain. The successful candidate will develop and implement strategies to deliver Investigational Product (IP)  in support of several clinical programs. Reporting to the Senior Director, Clinical Supply Chain this individual will develop strong collaborative relationships with several internal departments as well as third-party procurement, packaging, and distribution providers to align objectives and implement decisions which ensure clinical supply. The successful candidate will demonstrate strong attention to detail, which they will apply to the development and routine maintenance of clinical forecasts, inventory databases and IRT systems providing daily oversight of clinical supplies. Management and travel to CDMOs both domestically and internationally may be required.

Key Responsibilities

Leadership:

• Develop and update clinical supply strategies as needed to meet corporate demands
• Develop/maintain strong collaborative relationships with internal departments and external CDMOs
• Identify potential supply chain risks and develop & implement negotiated mitigation strategies
• Manage study/program budget, contracts and change orders and track spend against budget

Execution:

• Develop and working with Clinical, regularly update forecast/demand plans for late phase clinical trials.
• Collaborate with Quality, Clinical, CMC and external CDMOs to develop and approve clinical labels.
• Manage CDMO packaging/labeling schedules to ensure availability of clinical supplies.
• Interact regularly with third-party providers to manage logistics & licenses required to ship materials from manufacturing to bulk storage facilities, courier depots and investigator sites.
• Work with CMC and QA to facilitate document transfer required for IP/QP release by CDMOs
• Manage and track clinical supply inventory either manually or through an Interactive Response Technology (IRT) system.
• Manage Product Recovery pending investigation of IP from investigator sites as needed.

Collaboration:

• Effectively collaborate and communication across multiple functional areas, bringing a sufficient breadth of knowledge.
• Monitor shelf-life and expiry dating and coordinate retest extension with analytical team to ensure continuous supply.
• Manage investigation, reporting and communication of outcomes from temperature excursions and product complaints.
• Author and/or review supply chain sections of regulatory submissions
• If required, participate as SME in audits or for-cause inspection of CDMOs.
• Contribute as a SME to CDMO selection and approval process and review of associated Master Service Agreements (MSA) and Quality Agreements for clinical supply services
• Represent Supply Chain in Clinical and CMC Sub Team meetings

Qualifications

• Bachelor’s degree in engineering or science is required.
• 7+ years of biotech/pharma industry experience in clinical supply with significant international experience is required
• Experience in all aspects of clinical supply chain as well as a deep understanding of GMP/GDP
• Requires a strong understanding of managing groups, CMOs, CDMOs and other CDMOs
• Strong organizational, analytical, decision-making and interpersonal skills
• Ability to work on multiple projects independently in a fast-paced dynamic environment
• Demonstrated ability to coordinate CDMO activities in the development and commercialization of pharmaceutical products
• Excellent organizational skills, project management skills and detail-orientated leadership approach
• Willing and able to travel both domestically and internationally 

Work Location

The Associate Director, Clinical Supply Chain role is based in the US, with occasional travel (up to 20%).

Compensation

The annual base salary range for this position is $130,000.00 to $180,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge an location.

In addition to base pay, this role is eligible for a discretionary annual bonus. The Company also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

POSITION: Full-Time, Exempt