Principal Program Manager, Drug Discovery (CMC/Toxicology)

Calico•South San Francisco, CA

40d•$188,000 - $200,000•Onsite

About The Position

The Alliance and Program Management group is seeking a Principal Program Manager to support Chemistry, Manufacturing, and Controls (CMC) and Toxicology activities across the Drug Discovery and early Development portfolio. This role will partner closely with scientific, technical, and operational leaders across Drug Discovery, Development, Regulatory, Quality, and external partners to ensure effective planning, execution, and integration of CMC and toxicology programs in support of discovery and IND-enabling efforts. The Principal Program Manager will be responsible for coordinating complex, cross-functional programs spanning early development through IND readiness, including internal activities and external CRO/CDMO collaborations. This role will drive integrated planning, track execution against timelines and budgets, identify interdependencies and risks, and enable clear communication and decision-making across stakeholders. The successful candidate will balance a strategic portfolio-level perspective with detailed oversight of individual CMC and toxicology workstreams to ensure alignment on scope, resourcing, and deliverables.

Requirements

Bachelor’s degree in a life science or engineering discipline required; MS or PhD preferred
6+ years of program or project management experience in biotech or pharmaceutical drug development, with direct exposure to CMC and/or toxicology programs
Working knowledge of CMC development (e.g., drug substance/drug product development, manufacturing, formulation, analytical, supply) and nonclinical toxicology and safety assessment
Experience managing external CROs/CDMOs and sponsored research or development collaborations
Familiarity with IND-enabling workflows, development milestones, and regulatory considerations is strongly preferred
Proficiency with project management tools, methodologies, and best practices; experience with Smartsheet and Google applications preferred
Demonstrated ability to facilitate cross-functional teams, manage scope and timelines, and drive alignment across diverse stakeholders
Strong organizational and planning skills, with the ability to manage multiple complex programs and competing priorities
Excellent interpersonal and communication skills, with the ability to convey complex technical and operational information to scientific, operational, and leadership audiences
Proven ability to build trusted partnerships and foster collaboration across functions and with external partners
Experience designing and implementing process improvements in a matrixed organization
Critical thinker with strong initiative, judgment, and follow-through
Must be willing to work onsite at least four days per week

Responsibilities

Lead and manage medium to large, cross-functional CMC and toxicology programs supporting drug discovery and IND-enabling activities, including programs with external CROs, CDMOs, and industry partners
Develop and maintain integrated project plans and timelines across CMC, nonclinical safety, regulatory, and discovery interfaces
Coordinate and manage external engagements, including CROs and CDMOs, ensuring alignment on scope of work, deliverables, timelines, and communication cadence
Partner with Finance and functional leaders to track budgets, forecasts, and spend for CMC and toxicology programs
Facilitate cross-functional team meetings, governance forums, and external partner meetings; document decisions, risks, and action items to drive execution and accountability
Regularly assess program status, identify risks and interdependencies (e.g., material availability, tox study sequencing, regulatory milestones), and proactively propose mitigation strategies
Support portfolio-level planning, prioritization, and resource allocation across CMC and toxicology activities
Contribute to the development and continuous improvement of program management processes, tools, and best practices within Alliance & Program Management
Serve as alliance manager for selected external partnerships, managing relationships, performance, and issue resolution
Provide clear, concise communication to stakeholders and leadership on program progress, risks, and decision points