(Sr) Director, Clinical Supply Chain

COMPANY:

Centessa Pharmaceuticals plc (Nasdaq: CNTA) is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa companies are advancing a portfolio of high conviction programs with strong biological validation.

Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.

SUMMARY:

Centessa is currently seeking a (Sr.) Director, Clinical Supply Chain. The successful candidate will develop and implement strategies to deliver Clinical Trial Materials (CTM) in support of several clinical programs. This individual will develop strong collaborative relationships with several internal departments (Clinical, Regulatory, Quality and Manufacturing) as well as third-party procurement, packaging, and distribution providers to align objectives and implement decisions which ensure clinical supply. The successful candidate will have demonstrated a strong detail-oriented skill set 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.

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 finished goods and work with Manufacturing to develop production schedules which meet clinical demand.
• 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 CTM/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 CTM from investigator sites as needed.

Collaborate with internal teams 

• The successful candidate must be a very collaborative communicator with sufficient breadth of knowledge to converse across multiple functional areas.
• 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:

• 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
• Ability to thrive in a small company culture and assist in creating and implementing processes.
• Must be willing to travel both domestically and internationally 

EXPERIENCE:

• B.S. degree in engineering or science is required.
• At least 15 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

POSITION: Full-Time, Exempt, Remote Work with occasional travel

EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.