Vice President, Head of Toxicology
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.
We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.
We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.
With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
Summary:
The Head of Toxicology will be responsible for providing the overall toxicology strategy as well as program specific toxicology packages to support regulatory submissions for Cullinan’s immunology and oncology portfolio. The Head of Toxicology will work in a team-based setting to plan and execute nonclinical studies, provide nonclinical safety assessments, draft regulatory documents and contribute to achieving program goals. The successful candidate will have experience managing outsourced nonclinical GLP and non-GLP safety studies, including design, monitoring, execution and reporting of studies. As the nonclinical safety assessment lead for multiple programs, they will have responsibility for authoring regulatory documents and responses to inquiries from health authorities addressing global nonclinical development issues in support of IND/CTA/NDA filings. The successful candidate will have substantial experience in autoimmune disease and/or oncology drug development with the ability to contribute effectively to cross-functional drug development teams.
Position Responsibilities:
- Define and develop toxicology strategies to support clinical and preclinical portfolio programs
- Manage outsourced GLP and non-GLP toxicology and safety pharmacology work, and ensure compliance with global regulatory requirements
- Identify and work with CROs to oversee budgets, timelines, protocol designs and study monitoring; review, edit and finalize study reports
- Visit GLP testing sites to review facilities and capabilities for the conduct of studies, as needed
- Review, analyze, and summarize nonclinical safety data for internal presentations
- Lead authoring and review of toxicology/nonclinical sections for regulatory documents (e.g. IND/CTA/IB/DSUR/IMPD/NDA) to ensure clarity and regulatory compliance
- Represent toxicology on cross-functional teams to assist in internal decisions
- Provide strategic advice to project teams and senior management including evaluation of conclusions and impact of study results on program and clinical/regulatory strategy
- Proactively identify gaps and emerging risks in development programs, and engage external experts as needed to inform and guide risk management strategies
- Work closely with Research, Regulatory, Manufacturing, and Clinical colleagues to deliver on program and company objectives; collaborate with Clinical colleagues to ensure toxicology coverage for clinical trial designs
Candidate Requirements:
- Ph.D. in toxicology or pharmacology or related discipline with 10+ years of experience conducting toxicology studies within the pharmaceutical industry; Board certification (e.g., DABT) is highly desirable
- Toxicology experience to support autoimmune disease and/or oncology indications required; biologics experience a must, small molecule experience a plus; experience in both early- and late-stage drug development
- Track record of scientific excellence in toxicology or related scientific areas, evidenced by scientific publications and/or presentations at scientific conferences
- Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations for the conduct of nonclinical safety studies to support regulatory filings
- Extensive experience in planning and execution of both IND-enabling studies to support first-in-human studies and late-stage nonclinical toxicity studies
- Successful track record in leading outsourcing and monitoring of toxicology studies, effectively interacting with CRO study directors and others as needed in data analyses and interpretation for timely delivery of high-quality toxicology study reports
- Experience in authoring nonclinical safety data for submission to regulatory authorities (e.g., IND, NDA, MAA); experience in preparing science-based responses to health authority queries and presenting to authorities in person or virtually
- Highly collaborative; enjoys working closely with cross-functional colleagues and in a team-based setting
- Outstanding verbal communication and scientific writing skills as applied to study reports and regulatory documents
- Highly organized, with strong attention to detail, quality, and deadlines
- Sense of urgency and demonstrated ability to function successfully in a fast-paced and dynamic work environment, with the agility to quickly pivot in the face of new data and/or strategic direction
Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
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