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Role Description

Centessa is currently seeking an (Associate) Director, Clinical Supply Chain. The successful candidate will develop and implement strategies to deliver Clinical Trial Materials (CTM) 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.
  • Drive process optimization, scalability, and implementation of best practices and systems.
• Execution:
  • Develop and 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.
  • Support supply risk mitigation planning (e.g., shortages, delays, temperature excursions).
• Collaboration:
  • Contribute to SOP development, maintenance, and continuous improvement initiatives.
  • Effectively collaborate and communicate 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.
• 8-10 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, and CDMOs.
• Experience overseeing or managing blistering and walleting packaging processes required.
• Proven background in working with small molecule modality required.
• Demonstrated experience operating within a commercial drug product environment.
• 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-oriented leadership approach.
• Ability to thrive in a small company culture and assist in creating and implementing processes.
• Willing and able to travel both domestically and internationally.

Compensation

• The annual base salary range for the Associate Director, Supply Chain position is $170,000 - $225,000.
• The annual base salary range for the Director, Supply Chain position is $190,000 - $250,000.
• Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.
• In addition to base pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to share in Centessa’s long-term success.
• Centessa 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.

Work Location

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

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.