Senior Director, Head of Toxicology

Calico • South San Francisco, CA

119d • $340,000 - $350,000

About The Position

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. 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.

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.
• 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.

Nice To Haves

• Experience with a variety of therapeutic modalities (e.g., small molecules, biologics, oligonucleotides) is desirable.

Responsibilities

• 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.
• 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.
• Work with nonclinical/toxicology operations manager to select, manage, and oversee Contract Research Organizations (CROs) for the execution of nonclinical studies.
• Monitor study progress, address any issues that arise, and ensure the quality and integrity of study data.
• Work closely with CROs to develop and finalize study protocols and to review and sign off on draft and final study reports.
• 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.
• Identify potential safety liabilities and propose mitigation strategies.
• Proactively identify and assess potential toxicological risks associated with drug candidates and develop mitigation strategies.
• 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.
• 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.
• Contribute to scientific publications and presentations.

Benefits

• Base salary range of $340,000 - $350,000.
• Eligible for two annual cash bonuses.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees