Director of Toxicology New United States - Remote

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.

$220,000 - $240,000 USD

Compensation & Benefits At Praxis, we believe that taking care of our people (and 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. Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Praxis Precision Medicines, Inc.'s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A \"disabled veteran\" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A \"recently separated veteran\" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An \"active duty wartime or campaign badge veteran\" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An \"Armed forces service medal veteran\" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. #J-18808-Ljbffr Praxis Precision Medicines, Inc.