Associate Director, CMC Project Management

Summary

Join Nuvalent, a dynamic early-stage company focused on developing cancer treatments, as an Associate Director, CMC Project Management. Reporting to the Senior Director, you will be a key member of the Technical Operations team, managing CMC development strategies for one or more products. Collaborate with various departments (Pharmaceutical Development, Clinical Supply Chain, etc.) to ensure alignment with program strategies, timelines, and budget. You will coordinate cross-functional activities, manage projects in-house and with CDMOs, and support technical teams. Success requires strong project management skills, experience in biopharma manufacturing, and a deep understanding of CMC in small molecule/oral solid dosage forms. This role offers the opportunity to contribute to the development of life-saving medicines.

Requirements

• Requires a Bachelor's degree in Science, Engineering or a related field with at least 10+ years relevant industry experience in biopharma manufacturing/business; or Master's Degree in Science, Engineering, Business or a related field with 3-5+ years' relevant industry experience
• A minimum of 3-5+ years project management experience as either a designated project manager or PM responsibilities as part of a technical role
• Working knowledge of small molecule process development, formulation development, analytical development, GMP manufacturing and quality control testing
• Comprehensive project management skills
• MS Project and MS Teams
• Ability to accommodate flexible working hours to support business relationships in different time zones
• Up to 10% domestic and international travel may be required

Responsibilities

• In collaboration with technical leads, develop and manage risk mitigated CMC development strategies and project plans
• Coordinate and lead CMC Team meetings, including assembly of agendas and meeting minutes
• Ensure effective cross-function and cross-project communications in and out of internal development teams
• Support technical leads with vendor management including but not limited to contract review and negotiation, timeline management, and quarterly business review meetings
• Collaborate with Pharmaceutical Development and finance to forecast and manage the budget and quarterly accrual for all CMC activities
• Support Pharmaceutical Development with Request for Proposals, contracts, POs, and invoice approvals

Preferred Qualifications

• PMP certification is a plus
• Experience working with CMC Teams and managing relationships with CMC vendors (CDMOs) is strongly preferred
• Experience in a matrixed environment, effectively communicating cross functionally
• Experience in a fast-paced, small company environment
• Proficient with project management tools and techniques
• Strong business acumen
• Strong written/oral communication skills
• Ability to work independently and successfully in a matrix environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively
• Ability to foster effective relationships and collaboration, motivate others, influence without authority