Calico

Coordinate and oversee preclinical drug discovery projects, ensuring seamless communication, timely delivery, and budget adherence across internal and external teams. | A Ph.D. or M.S. in Chemistry or related field with significant experience managing scientific workflows and external CRO partnerships, along with strong organizational, communication, and project management skills. | Who We Are: Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs. Position Description: Calico seeks a Drug Discovery Senior / Principal Operations Manager as a key driver in advancing our preclinical drug discovery pipeline from hit generation through to the nomination of a clinical candidate. You will be responsible for bridging the gap between internal scientific strategy and internal/external execution. This role requires exceptional organizational skills, deep scientific understanding of the drug discovery process, the Design-Make-Test-Analyze (DMTA) cycle and an ability to effectively manage complex, multi-disciplinary projects executed primarily through external CROs. The successful candidate will be able to effectively communicate among the relevant internal and external stakeholders to achieve robust, efficient pipeline operations that support the goals of Calico Drug Discovery. The Operations Manager acts as the central hub for communication, planning, and execution, ensuring projects are delivered on-time, within scope, and on-budget, while maintaining the highest scientific and productivity standards for successful preclinical candidate nominations. Responsibilities: Act as the "glue" between Chemistry, Biology and DMPK teams to ensure seamless data flow and resource allocation Rigorously monitor CRO performance against the agreed-upon SOW, budget, and timeline, proactively identifying and mitigating potential delays or scope creep Ensure clear and consistent communication, monitor data quality, protocol troubleshooting and technical alignment among all internal team members/labs, external CROs, and collaborators Facilitate and document team meetings to enable cross-functional communication, decision-making, and alignment with internal and external stakeholders Work closely with Drug Discovery Project Lead and internal scientific functional leads to define clear milestones, deliverables, and decision points (Go/No-Go criteria) Meet regularly with stakeholders to assess the states of ongoing projects, identify current or projected problems, anticipate delays before they happen and proactively suggest/implement solutions Lead and/or contribute to the development of processes and tools to enable planning, prioritization, tracking, and execution of pipeline projects Ensure the seamless and compliant transfer of data, materials, and biological samples between internal facilities and external partners Manage contracts and financial tracking related to external spend, processing invoices, and forecasting future expenditures with finance and procurement teams Ensure that business critical contracts are executed in a timely manner Develop and distribute regular project status reports detailing progress, key findings, risks, and mitigation strategies to senior management and internal stakeholders Organize and manage project documentation, ensuring all project records and data summaries are centralized, current, and audit-ready Develop and manage project plans and integrated timelines for pipeline projects as needed Position Requirements: Ph.D. in Chemistry or a related field with 2+ years of industrial experience or an M.S. with 6+ years of progressive responsibility in drug discovery A proven ability to manage diverse scientific workflows through external partnerships is essential, including experience directing international and domestic CROs across multiple disciplines Deep scientific literacy in drug discovery processes (e.g., DMTA cycle, target identification, hit-to-lead, lead optimization, preclinical safety assessment) Experience with project management tools (Smartsheet, Gantt, Excel, PowerPoint, Word) and drug discovery informatics (ChemDraw, corporate compound databases, Chemoinformatics Analysis and Visualization tools, ELN systems) Project management experience with demonstrated proficiency in tracking logistics of compound movement through target screening funnels across a portfolio of projects is desired Ability to maintain alignment with internal and external stakeholders while managing project scope, deliverables, risks, and resources is expected Outstanding organization and planning skills to effectively manage competing priorities, resources, and activities within and across a diverse portfolio of projects and programs is required Exceptional negotiation, communication, and interpersonal skills required to manage complex relationships with external vendors and internal stakeholders Ability to manage budgets and accurately forecast external expenditures Ability to confidently make decisions that align with the scientific strategy in a fast-paced environment Strong risk assessment and problem-solving skills, with an ability to function effectively in a fast-paced, high-pressure environment Ability to effectively communicate complex information, issues, and potential solutions across the organization, including leadership and external collaborators Ability to foster partnerships and effective collaboration within and across teams Ability to design and implement medium-to-large-scale process improvements Must be willing to work onsite at least four days a week Nice to Have: PMP (Project Management Professional) or equivalent certification is highly preferred Demonstrated ability to apply structured PM methodologies (Agile, Waterfall, or Lean) to accelerate drug discovery timelines and optimize CRO deliverables The estimated base salary range for this role is $153,000 - $200,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.

Lead and oversee all toxicology studies from discovery through clinical development, manage CROs, analyze toxicology data, and ensure regulatory compliance for drug safety. | Ph.D. in Toxicology or related field, board certification (D.A.B.T.), 8+ years pharmaceutical toxicology experience, strong GLP knowledge, regulatory expertise, and onsite work commitment. | Who We Are: Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs. Position Description: We are seeking a highly experienced and visionary Senior Director, Head of Toxicology to lead our toxicology and preclinical safety efforts. The ideal candidate will be a strategic and hands-on leader responsible for designing, implementing, and overseeing all toxicology studies, from early discovery through clinical development and registration. This role will be critical in ensuring the safety of our drug candidates and contributing to successful regulatory filings. Key Responsibilities: • Toxicology Strategy and Planning: • Develop and execute the overall toxicology strategy for each project and therapeutic candidate in the company's portfolio, aligning with project goals and regulatory requirements, from drug discovery and initial target safety assessment, lead optimization, and preclinical/clinical development programs • Provide expert guidance on all aspects of toxicology, including study design, regulatory requirements, and risk assessment • Partner closely with research, pharmacology, clinical, CMC, and regulatory teams to ensure seamless integration of toxicology data into the overall development plan • Study Management and Oversight: • Work with nonclinical/toxicology operations manager to select, manage, and oversee Contract Research Organizations (CROs) for the execution of nonclinical studies, ensuring high-quality data generation and timely deliverables • Work with nonclinical/toxicology operations manager to monitor study progress, address any issues that arise, and ensure the quality and integrity of study data • As primary Sponsor representative, work closely with CROs to develop and finalize study protocols and to review and sign off on draft and final study reports • Data Analysis and Interpretation: • Critically analyze and interpret toxicology data from in vitro and in vivo studies to support drug candidate selection, safety assessments, and dose-ranging strategies • Prepare or oversee development of comprehensive toxicology reports and present findings to project teams and management, including to internal review committees • Identify potential safety liabilities and propose mitigation strategies • Proactively identify and assess potential toxicological risks associated with drug candidates and develop mitigation strategies • Collaboration and Communication: • Serve as the toxicology representative on cross-functional project teams, providing expert input and contributing to overall drug development strategy • Effectively communicate toxicology findings and recommendations to internal and external stakeholders • Build and maintain strong relationships with CRO partners and other external collaborators • Regulatory and Scientific Expertise: • Author and review toxicology sections for regulatory documents, including INDs, CTAs, NDAs, and BLAs • Serve as the primary toxicology representative for interactions with global regulatory agencies (e.g., FDA, EMA) • Stay abreast of the latest advancements in toxicology, regulatory guidelines, and best practices • Ensure that all toxicology activities are conducted in compliance with relevant regulatory requirements (e.g., FDA, EMA, ICH) • Contribute to scientific publications and presentations Position Requirements: • Ph.D. in Toxicology, Pharmacology, Pathology, or a related scientific discipline • Board certification in Toxicology (D.A.B.T.) is required • 8+ years of progressive experience in toxicology within the pharmaceutical or biotechnology industry • Strong understanding of GLP toxicology principles and their application to drug discovery and development • Extensive experience designing, conducting, overseeing, and interpreting a full range of nonclinical toxicology studies (e.g., general toxicology, safety pharmacology, genotoxicity, carcinogenicity, reproductive toxicology) • Excellent written and verbal communication, interpersonal, and collaboration skills • Experience in managing CROs and external partnerships • Strong understanding of global regulatory guidelines (e.g., ICH, FDA, EMA) • Experience with a variety of therapeutic modalities (e.g., small molecules, biologics, oligonucleotides) is desirable • Proven track record of preparing and defending toxicology data in regulatory submissions (IND/CTA, NDA/BLA) • Must be willing to work onsite at least 4 days a week The estimated base salary range for this role is $340,000 - $350,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.