Job Description

Position Summary:

The Director/Sr. Director of Toxicology will lead the design, analysis, interpretation, and reporting of toxicology and safety pharmacology data for Sagimet’s drug development programs. This role will be responsible for developing and implementing toxicology strategies to support the advancement of drug candidates from discovery through clinical development and regulatory approval. The ideal candidate will have extensive experience in nonclinical safety assessment, a deep understanding of regulatory guidelines, and the ability to collaborate cross-functionally with project teams and external partners. This is a role whereby the candidate directly oversees contract research organizations (CROs). The candidate will be an important member of the R&D team and will also contribute to pharmacology and DMPK aspects of drug development programs.

Essential Responsibilities:

• Develop the toxicology strategy for each drug candidate throughout the stages of development from preclinical to post-marketing.
• Design and oversee nonclinical safety studies, including GLP safety pharmacology and toxicology studies, conducted through contract research organizations (CROs).
• Evaluate and interpret results of safety pharmacology and toxicology studies and toxicokinetic data.
• Serve as the subject matter expert in nonclinical safety pharmacology and toxicology, advising program teams and authoring/editing GLP study reports and pertinent sections of regulatory filings.
• Author and submit regulatory documents (e.g., INDs, CTAs, NDAs, BLAs, briefing books, Investigator Brochures) and interact with regulatory agencies (US and ex-US) as needed.
• Generate impurity, excipient, and metabolite risk assessments as necessary during the life cycle of a drug candidate.
• Provide strategic guidance to project teams and senior management on the potential impact of toxicology results on program and strategy.
• Develop experimental strategies to understand the mechanisms of toxicity as needed.
• Build and maintain effective relationships with CROs and consultants to support the execution of non-GLP and GLP toxicology studies.
• Support other team members in drug development and the execution of the portfolio, with an emphasis on nonclinical aspects. Play a leadership role in integration of data across toxicology, pharmacology and DMPK disciplines.
• Other duties as assigned.

Education and Experience Requirements:

• PhD in toxicology, pharmacology, or a closely related discipline.
• 5+ years of post-graduate drug development experience within the pharmaceutical or biotechnology industry on toxicology studies.
• In-depth understanding of safety pharmacology, investigative and regulatory toxicology, and experience designing exploratory and GLP-compliant toxicology studies including to NDA submission.
• Experience authoring the toxicology sections of investigator brochures and regulatory documents using knowledge of relevant ICH guidance documents and other regulations.
• Extensive experience conducting GLP-compliant studies through contract research organizations in a virtual biotech setting.
• Demonstrated ability to critically evaluate and interpret the results from nonclinical safety studies of small molecule drug candidates, including the likely impact on clinical study design.
• Ability to provide toxicology expertise across a variety of therapeutic areas.

Preferred Skills:

• Excellent interpersonal skills, with the ability to develop important relationships with key stakeholders, manage conflicts, and negotiate effectively.
• Strong analytical skills, with the ability to communicate complex concepts and study results in written and verbal form to a range of audiences, including executive management, regulatory agencies, collaborators, and potential partners.
• Leadership skills to manage development strategies beneficial
• Highly motivated self-starter with strong organizational skills, capable of managing and simultaneously advancing multiple tasks and projects.
• Ability to translate strategy into action and demonstrate flexibility, proactivity, resourcefulness, and efficiency in a fast-paced, innovative environment.

Salary range:

• Director = $225,000 - $250,000 per year
• Sr. Director = $275,000 - $315,000 per year

Actual compensation within this range will be based on the experience and qualifications of the selected candidate.

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