Senior Director, Toxocology

Scorpion Therapeutics; Bedford (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Stoke Therapeutics is seeking a Senior Toxicologist to lead nonclinical safety assessments supporting gene-based drug programs, including antisense oligos for CNS and eye indications. The role involves directing in vitro/in vivo toxicology studies, coordinating CROs, and preparing regulatory safety data for INDs and NDAs.

You will develop safety strategies aligned with industry guidelines and interact with regulatory agencies, with hybrid work setup in Bedford/Waltham MA and travel about 10%.

Qualifications

• Ph.D. in Pharmacology, Toxicology, or DVM required.
• 7+ years in industry supporting therapeutic development with toxicology across general, reproductive, carcinogenicity, and safety pharmacology.
• Experience with FDA GLP and global regulatory submissions.
• Proven CRO management experience.

Responsibilities

• Oversee design, management, and interpretation of in vitro/in vivo toxicology studies.
• Coordinate with CROs.
• Prepare regulatory safety data for INDs, CTAs, NDAs.
• Develop safety strategies aligned with industry guidelines.
• Interact with regulatory agencies.

Skills

Toxicology expertise across various by

FDA GLP & global regulatory experience

CRO management

Education

Ph.D. in Pharmacology, Toxicology, or DVM

Job description

Role

Senior Toxicologist responsible for leading nonclinical safety assessments to support Stoke Therapeutics' gene-based drug programs, including antisense oligonucleotides for CNS and eye diseases.

Responsibilities

• oversee design, management, and interpretation of in vitro/in vivo toxicology studies
• coordinate with CROs
• prepare regulatory safety data for INDs, CTAs, NDAs
• develop safety strategies aligned with industry guidelines
• and interact with regulatory agencies

Requirements

• Ph.D. in Pharmacology, Toxicology, or DVM
• 7+ years in industry supporting therapeutic development, with experience in toxicology across general, reproductive, carcinogenicity, and safety pharmacology
• FDA GLP and global regulatory experience
• strong CRO management skills

Preferred

• DABT certification
• experience with oligonucleotides or mRNA therapeutics
• drug development in CNS or ocular indications

High Value

• biopharma, gene therapies, RNA modalities, CNS and eye indications, safety pharmacology, regulatory document authoring, global agency interactions

Work Setup

hybrid Bedford/Waltham MA; travel ~10%