Senior Director, Head of Toxicology

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.