CMC Program Manager

Role Summary

The CMC Program Manager partners with CMC leadership and cross-functional project teams to develop and collaboratively execute CMC strategies in alignment with program and company goals. The successful candidate will work with colleagues in Technical Operations, Quality, Regulatory, Discovery, Development, and Product Strategy to develop pipeline programs and will support the management of CRO/CMO relationships and the business systems/tools used by Technical Operations.

Responsibilities

• Manage integrated CMC project plans, timelines, risks and costs for synthetic (“small molecule”) and biologic (“large molecule”) drug candidates from pre-IND and first-in-human testing through later phases of development, including pivotal Phase 2/3 studies and NDA/MAA/BLA submission
• As appropriate, support CRO/CMO vendor selection process and serve as a point of contact for CROs and CMOs for outsourced CMC projects
• Manage internal CMC project teams by drafting agendas, facilitating meetings, drafting minutes, and following up on action items, while helping foster a collaborative team culture
• Establish and maintain CMC project timelines and track CMC deliverables and timelines to ensure alignment with the overall project plans
• Support the development and assessment of CMC strategies and project risk management, in partnership with the CMC program leader and CMC team members
• Provide regular updates to the core team and senior management on project status, timelines, risks, and forecasting for future CMC project needs
• Work with CMC technical leads to develop and track the CMC budget, including managing spend at CROs/CMOs; Proactively communicate changes to the core and finance teams
• Coordinate timeline development for building business systems and manage execution to the timelines; Support the implementation of business systems and tools for Technical Operations

Qualifications

• Typically requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience.
• Excellent organizational and communication skills; Keen attention to detail
• Outstanding interpersonal skills to build and maintain strong relationships across Denali and with collaborators at CROs/CMOs
• Evidence of strong strategic thinking, analytical, and planning skills
• Demonstrated ability to multitask and successfully deliver on timelines in a dynamic, fast-paced environment
• Working knowledge of project management fundamentals
• Experience supporting CMC development and interfacing with cGMP manufacturing operations