毒理学总监
Director of Toxicology
职位地点:该职位可远程办公,但需要具备灵活安排并愿意根据需要出差
机会简介
作为毒理学总监,您将为Praxis不断扩展的针对中枢神经系统疾病的新分子和反义寡核苷酸(ASO)疗法组合中的非临床安全活动提供科学、战略和监管领导。
您将负责指定项目的毒理学策略,并领导从发现和候选药物选择到IND支持性开发以及NDA/MAA阶段的非临床安全工作。您将提供实际的科学领导,解读新兴的安全性发现,并将复杂的数据转化为清晰的建议,供项目团队、管理层和监管机构参考。
如果您具备深厚的毒理学专业知识、强大的监管判断力和主人翁意识,您将在这一职位上表现出色。您能够预见风险,挑战假设,应对不确定性,并制定切实可行的前进路径——帮助Praxis以速度和科学严谨性推进有前景的药物进入患者手中。随着职能的发展,总监可能需要负责带领和培养直接下属,通过确立明确的重点,提供科学指导和建设性反馈,并创造更多自主权和职业发展的机会。
主要职责
- 负责所分配项目的非临床安全策略,确保毒理学计划支持候选药物选择、IND支持性开发、临床进展以及后期的监管里程碑。
- 设计并监督发现、探索性、研究性和注册用毒理学研究,包括非GLP和GLP研究,从方案制定到结果解读和最终报告。
- 评估新兴安全性发现,评估其对人类风险的相关性,并为开发团队推荐清晰、务实的前进路径。
- 领导监管毒理学工作,包括对IND、CTA、IB、DSUR、NDA/MAA相关文件的贡献,以及对FDA和其他全球卫生监管机构问题的回应。
- 指导CRO、顾问和其他外部合作伙伴,确保他们对科学质量、合规性、时间表和透明沟通负责。
- 与发现、DMPK、生物分析、临床药理学、监管、临床等其他部门合作,将非临床安全整合到项目策略和决策中。
- 代表非临床安全
查看英文原文
Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
The Opportunity
As Director, Toxicology, you will provide scientific, strategic, and regulatory leadership for nonclinical safety activities across Praxis’s growing portfolio of novel small molecule and antisense oligonucleotide (ASO) therapies for CNS disorders.
You will own toxicology strategy for designated programs and lead nonclinical safety activities from discovery and candidate selection through IND-enabling development and toward NDA/MAA. You’ll provide hands-on scientific leadership, interpret emerging safety findings, and translate complex data into clear recommendations for program teams, leadership, and regulatory authorities.
You’ll thrive in this role if you bring deep toxicology expertise, strong regulatory judgment, and an ownership mindset. You anticipate risks, challenge assumptions, navigate ambiguity, and develop pragmatic paths forward—helping Praxis advance promising medicines to patients with speed and scientific rigor. As the function grows, the Director may assume responsibility for leading and developing direct reports by establishing clear priorities, providing scientific guidance and constructive feedback, and creating opportunities for increased ownership and professional growth.
Primary Responsibilities
- Own nonclinical safety strategy for assigned programs, ensuring toxicology plans support candidate selection, IND-enabling development, clinical progression, and later-stage regulatory milestones.
- Design and oversee discovery, exploratory, investigative, and regulatory toxicology studies, including non-GLP and GLP studies, from protocol development through interpretation and final reporting.
- Evaluate emerging safety findings, assess their relevance to human risk, and recommend clear, pragmatic paths forward for development teams.
- Lead regulatory toxicology activities, including contributions to INDs, CTAs, IBs, DSURs, NDA/MAA-related documents, and responses to FDA and other global health authority questions.
- Direct CROs, consultants, and other external partners, holding them accountable for scientific quality, compliance, timelines, and transparent communication.
- Partner across Discovery, DMPK, Bioanalytical, Clinical Pharmacology, Regulatory, Clinical, and other functions to integrate nonclinical safety into program strategy and decision-making.
- Represent Nonclinical Safety Assessment on cross-functional teams, communicate risks and recommendations clearly, and help ensure the right decisions are made with speed, rigor, and patient impact in mind.
Qualifications and Key Success Factors
- Master's degree or PhD preferred in Toxicology, Pharmacology, Pharmacy, Biology, or a related scientific discipline. DABT certification is desirable.
- 8+ years of relevant biotechnology, pharmaceutical, CRO, regulatory agency, or combined experience, with meaningful responsibility for nonclinical safety programs and significant experience directing or monitoring toxicology studies.
- Deep expertise in general toxicology and the design, conduct, interpretation, and reporting of nonclinical safety studies. Experience in reproductive toxicology, genetic toxicology, safety pharmacology, carcinogenicity, and/or abuse potential assessment is highly desirable.
- Strong command of regulatory toxicology, including working knowledge of ICH, FDA, OECD, and other applicable U.S. and international requirements and guidance. Prior experience as an FDA Pharmacology/Toxicology reviewer—or comparable experience navigating complex nonclinical interactions with global health authorities—is highly valued.
- In-depth knowledge of Good Laboratory Practices and demonstrated ability to provide effective scientific oversight of GLP studies performed by external partners.
- Experience leading and developing toxicology talent, including setting clear expectations and priorities, providing scientific and career coaching, fostering accountability, trust, and continuous learning, and delegating meaningful ownership while remaining accessible for guidance and escalation.
- The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You’ll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.
Annualized Base Salary
$220,000—$240,000 USD
Compensation & Benefits
At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!
Company Overview
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
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