Senior Advisor, Study Operations Manager – Nonclinical Toxicology

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

📋 Description

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

• Lead the drafting of Statements of Work (SOWs) with various CROs for awarded studies in partnership with toxicology project representatives.

• Implement SOWs promptly.

• Collaborate with CRO study directors to commence the internal review process for draft study protocols and reports related to toxicology and safety pharmacology studies.

• Facilitate compound shipments in conjunction with the CMC team.

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

• Monitor study deliverables and provide regular updates on study progress to team members, regulatory leads, and senior management.

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

• Participate in project meetings and accelerate study-related tasks as necessary.

• Offer updates to project teams upon request.

⛳️ 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, focusing on nonclinical toxicology/safety pharmacology and ADME/DMPK studies with CROs and external development partners.

• Strong grasp of biological sciences and nonclinical research methodologies.

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

• Proficient in scientific data analysis software, databases, and data management systems, with the ability to quickly learn and adapt to new software tools.

• Exceptional communication (both oral and written), listening, negotiation, and interpersonal relationship skills.

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

• Familiarity with contributing to IND or CTA submissions.

• Knowledge of FDA, EMA, and ICH regulatory requirements.

• Experience in dynamic, matrixed biotechnology settings.

• Outstanding organizational skills.

• Technologically adept.

• Naturally inquisitive and deeply passionate about the work we undertake.

• Ability to navigate ambiguity and advocate for new practices and technologies.

• Strong problem-solving skills.

🏝️ Benefits

• Company bonus based partially on company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical coverage.

• Dental coverage.

• Vision coverage.

• Prescription drug coverage.

• Flexible spending accounts for healthcare and/or dependent day care.

• Life insurance and death benefits.

• Specific time off and leave of absence benefits.

• Employee assistance program.

• Fitness benefits.

• Employee clubs and activities.