Senior Director, Program Management, CMC

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 continues to expand its CMC group and currently seeks a Senior Director of Program Management within the CMC group. The CMC Project Manager will provide leadership and operational support to the development and manufacturing of our small molecule programs, and actively engage with internal teams and external contract manufacturing organizations.  The individual will drive effective execution of CMC deliverables by the project teams in coordination with and support of program and corporate goals.  The ideal candidate should be highly organized and an exceptional communicator with experience leading early phase pre-IND teams through late-stage CMC Registration/Commercial validation and launch activities.  Travel to vendors both domestically and internationally will be required.

RESPONSIBILITIES:

• Serve as the main point of contact for all CMC project-related communications, fostering strong relationships with internal teams, and external partners including CDMOs.
• Participate in regular telecon meetings with CDMOs to maintain the business relationship, progress, meeting notes and action items.
• Monitor timelines and contracts for accuracy and follows up on any discrepancies with contractors and/or internal personnel.
• Support CMC activities including tracking of relevant GMP and Regulatory documentation.
• Interfaces with drug substance, drug product, analytical, non-clinical, clinical, Regulatory, supply chain, and Quality colleagues to ensure all projects are delivered on time, within scope and budget.
• Work with CMC team members to identify resource constraints, risks, and conflicts that could impact the team’s bandwidth and/or company timelines.
• Cover all other project management requirements including shipment/logistics coordination and detailed project plans.
• Drive the development and management of detailed and integrated development plans for CMC projects that account for all phases of drug development across functions with timelines, work plans including interdependencies, budget, and risk management strategies.
• Oversee the delivery of project objectives per the program strategy, with a strong focus on meeting critical milestones, and managing scope changes while integrating project constraints.
• Facilitate effective collaboration across CMC functional teams, ensuring alignment on project goals and priorities.
• Communicate project updates consistently to various stakeholders, about strategy, adjustments, and development progress.
• Experience utilizing project management tools and best practices to support CMC activities.
• Excellent attention to detail, communication, time management, organizational skills, and flexible attitude to work assignments and new learning with proven ability to interact in a team environment.
• Comfortable in a fast-paced small company environment with the ability to manage a variety of projects simultaneously and handle rapidly changing information.
• Project management professional (PMP) certification preferred.
• Expert MS Office skills including Excel, PowerPoint, MS Project, other PM timeline software.

QUALIFICATIONS:

• Demonstrated understanding of the drug development process including key disciplines involved in drug development (including but not limited to CMC, non-clinical, clinical, regulatory filing activities).
• Thorough understanding of cGMP requirements for pharmaceutical products
• Strong organizational, analytical, and interpersonal skills
• Ability to work independently in a fast-paced dynamic environment with multiple projects.
• Demonstrated ability to coordinate CDMO activities in the development and commercialization of pharmaceutical products.
• Strong decision-making and communication skills and resource management skills in a dynamic environment located across multiple geographies.
• Excellent organizational skills, project management skills and detail-orientated leadership approach
• Must be willing to travel both domestically and internationally.

EXPERIENCE:

• At least 10+ years of pharmaceutical industry experience. Experience in small molecule development program preferred.
• At least 5+ years of project management leadership experience; with a primary focus on project/program management of CMC-related activities
• Demonstrates personal drive and goal-oriented, decision-making.
• Self-motivated taking personal pride in delivering on personal and corporate objectives.
• Enthusiastic and flexible to changing business deliverables and multiple, moving program priorities.
• Demonstrates organizational and prioritization skills to manage a diverse workload.
• Able to interact with individuals at all levels of the organization.
• Excellent oral and written communication. Understanding of CMC requirements for all phases of clinical development.
• Excellent writing and communication skills with an ability to understand and communicate scientific information.
• Proven ability to communicate in a clear and concise manner.
• Ability to work independently, cross functionally and collaboratively in a team.

POSITION: Full-Time, Exempt, Flexibility for Remote Work

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.