Associate Director, Study Operations Manager – Nonclinical Toxicology

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee the complete data flow between external Contract Research Organizations (CROs) and internal teams, ensuring precision, consistency, and alignment with study goals.

• Collaborate with toxicology project representatives to initiate draft Statements of Work (SOWs) with various CROs for awarded studies.

• Facilitate the internal evaluation of draft study protocols and reports for toxicology and safety pharmacology studies alongside DMPK, CMC, and bioanalytical team members.

• Organize compound shipments in partnership with the CMC team.

• Supervise nonclinical toxicology and safety pharmacology studies at external CROs, either onsite or remotely, guaranteeing scientific quality and adherence to global regulatory standards.

• Monitor study deliverables and provide timely progress reports to team members, regulatory leads, and senior management.

• Maintain a consolidated calendar with the Project Management team to anticipate portfolio study deliverables and allocate resources effectively.

• Participate in project meetings, accelerate study-related tasks, and relay updates to project teams.

⛳️ Requirements

• Bachelor’s or Master’s degree in toxicology, pharmacology, or a related field.

• At least 6 years of experience in the biotechnology or pharmaceutical industry, specifically in managing nonclinical toxicology/safety pharmacology and ADME/DMPK studies with CROs and external development partners.

• Strong comprehension of biological sciences and methodologies in nonclinical research.

• Demonstrated ability to oversee multiple concurrent toxicology/safety pharmacology, ADME/DMPK studies, timelines, and data deliverables.

• Proficient in scientific data analysis software, databases, and data management systems.

• Exceptional oral and written communication abilities, along with strong listening, negotiation, and interpersonal skills.

• Experience in supporting CNS, neuroscience, sleep-wake, rare diseases, or related therapeutic areas.

• Involvement in contributing to IND or CTA submissions.

• Familiar with FDA, EMA, and ICH regulatory guidelines.

• Experience working in dynamic, matrixed biotechnology settings.

• Strong organizational skills and technological proficiency.

🏝️ Benefits

• Company bonus based partially on individual and company performance.

• Company-sponsored 401(k).

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• Flexible benefits options, including healthcare and/or dependent day care flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence policies.

• Well-being programs, including an employee assistance program, fitness benefits, and opportunities for employee clubs and activities.

• Employee resource groups and support networks.