Associate Principal Scientist, Toxicology/Study Director

Scorpion Therapeutics; Pennsylvania; On-site; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a Study Director in toxicology based in Pennsylvania. You will oversee acute to chronic general toxicology studies across modalities, ensuring GLP compliance and timely execution while coordinating with science, veterinary, and regulatory teams.

The role requires 8+ years of experience, 5+ years as a Study Director, and strong leadership and communication skills for regulatory submissions and cross-functional collaboration.

Qualifications

• Master’s degree in toxicology, pharmacology, or related discipline.
• 8+ years of relevant experience in toxicology or drug safety.
• 5+ years as a Study Director in pharma/biotech/CRO.
• GLP General Toxicology Study Director experience with varied models/designs.
• Strong knowledge of GLP and US FDA 21 CFR Part 58.
• Strong collaboration, communication, and leadership skills.
• Excellent verbal and written presentation abilities.

Responsibilities

• Serve as Study Director for acute to chronic general toxicology studies across modalities.
• Interact with scientific staff to ensure protocol and SOP compliance.
• Analyze and interpret data; prepare regulatory submission reports.
• Ensure regulatory rigor and timely study execution.
• Collaborate across functions to identify opportunities and provide solutions.
• Lead method development and cross-group initiatives as needed.

Skills

Study Director

GLP Compliance

Regulatory Submissions

Toxicology

Cross-functional

Data interpretation

Leadership

Communication

Protocol development

Teamwork

Education

Master’s degree in toxicology

Job description

Key Responsibilities

• Serve as single point of control (Study Director) on assigned acute through chronic general toxicology studies across all modalities.
• Interact with technical, veterinary, and scientific staff to ensure study compliance with protocol, amendments, SOPs, regulations, safety guidelines, and company policies.
• Critically analyze and interpret data; integrate clinical pathology, pathology, toxicokinetics into regulatory submission reports; communicate results within established timelines.
• Ensure regulatory rigor, proactive risk identification, and timely study execution.
• Demonstrate enterprise mindset and strategic thinking; proactively identify opportunities/challenges and contribute solutions aligned with Nonclinical Drug Safety priorities.
• Build collaborative relationships and influence without authority; support inclusive team environment.
• Deliver high-quality results with accountability and agility; translate objectives into action and continuously improve.
• Lead and/or participate in method development, inter-group initiatives, and related scientific projects (as needed).

Education

• Master’s degree with training in toxicology, pharmacology, or related discipline.

Requirements

• Minimum 8 years relevant experience.
• Minimum 5 years as a Study Director in pharma, biotech, or CRO.
• GLP General Toxicology Study Director experience with varied models, routes, and study designs.
• Demonstrated understanding of GLP (US FDA 21 CFR Part 58).
• Strong interest in cross-functional collaboration and open communication.
• Strong listening and leadership skills.
• Ability to communicate clearly (verbal and written, including presentations).

Preferred

• GLP Study Director experience with varied modalities (e.g., biologics, small molecules).
• Familiarity with outsourced study monitoring.
• Familiarity with ICH safety guidelines.

Required Skills

Animal studies; effective written communication; evaluate information; GLPs; oral communications; proactive thinking; study directing; study monitoring; teamwork; toxicology.