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Calico Life Sciences · 4 months ago

Senior Director, Head of Toxicology

South San Francisco, CA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$340K/yr - $350K/yr

8+ years exp

Calico Labs is a research and development company focused on understanding human aging to enable healthier lives. They are seeking a Senior Director, Head of Toxicology to lead toxicology and preclinical safety efforts, ensuring the safety of drug candidates and contributing to regulatory filings.

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, 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

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

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

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 (e.g., FDA, EMA, ICH)

Contribute to scientific publications and presentations

Qualification

. in ToxicologyBoard certification in ToxicologyGLP toxicology principlesNonclinical toxicology studiesGlobal regulatory guidelinesManaging CROsTherapeutic modalitiesPreparing regulatory submissionsCommunication skillsInterpersonal skillsCollaboration skills

Required

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)

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

Preferred

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

Benefits

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

Calico Life Sciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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