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Calico Life Sciences · 18 hours ago

Principal Program Manager, Drug Discovery (CMC/Toxicology)

South San Francisco, CA

Full-time

Hybrid

Senior Level, Lead/Staff

$188K/yr - $200K/yr

6+ years exp

Calico Life Sciences LLC is a research and development company focused on understanding human aging to create medical breakthroughs. They are seeking a Principal Program Manager to oversee Chemistry, Manufacturing, and Controls (CMC) and Toxicology activities in drug discovery, ensuring effective planning and execution across various teams and external partners.

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

Qualification

Program ManagementCMC DevelopmentToxicology KnowledgeProject Management ToolsRegulatory ConsiderationsCross-Functional Team LeadershipCommunication SkillsOrganizational SkillsCritical Thinking

Required

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

Preferred

MS or PhD

Familiarity with IND-enabling workflows, development milestones, and regulatory considerations

Experience with Smartsheet and Google applications

Benefits

Eligible for two annual cash bonuses

Company

Calico Life Sciences

Glassdoor4.1

Calico is an Alphabet-founded research and development company whose mission is to harness advanced technologies.

Founded in 2013

South San Francisco, California, USA

201-500 employees

http://www.calicolabs.com/

H1B Sponsorship

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