The posting
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Study Operations Manager – Nonclinical Toxicology based in the United States.
As an Associate Director, Study Operations Manager, you will oversee the planning, execution, and monitoring of nonclinical toxicology and safety pharmacology studies supporting innovative drug development programs. You will coordinate closely with contract research organizations (CROs) and internal scientific teams to ensure studies meet quality standards, timelines, budgets, and regulatory requirements. This role offers the opportunity to contribute to the advancement of promising therapeutic candidates through rigorous study management and reliable data delivery. You will manage study documentation, review protocols and reports, coordinate cross-functional activities, and maintain visibility across a diverse research portfolio. Working in a dynamic, collaborative biotechnology environment, you will help strengthen nonclinical development capabilities and support critical research milestones. The ideal candidate combines strong scientific knowledge with exceptional organizational skills, proactive problem-solving, and a passion for advancing treatments that can make a meaningful difference in patients' lives.
Accountabilities
- Oversee the end-to-end operational management of nonclinical toxicology and safety pharmacology studies conducted by external CROs, ensuring scientific quality, regulatory compliance, and alignment with study objectives.
- Manage data flow between external research partners and internal teams, maintaining data accuracy, consistency, integrity, and timely delivery throughout the study lifecycle.
- Initiate and coordinate statements of work (SOWs) with multiple CROs in collaboration with toxicology project representatives, ensuring study designs are accurately documented and agreements are completed on schedule.
- Coordinate the preparation and internal review of draft study protocols and final reports with study directors and cross-functional teams, including DMPK, CMC, and bioanalytical specialists.
- Organize and track compound shipments in collaboration with CMC teams to ensure materials are available when needed for study execution.
- Monitor study progress remotely or on-site, proactively identifying operational challenges, resolving issues, and ensuring adherence to established timelines, quality expectations, and applicable global regulatory requirements.
- Track key study milestones, deliverables, and dependencies, providing timely and accurate progress updates to project teams, regulatory leads, and senior management.
- Collaborate with project management teams to maintain an integrated study calendar, forecast deliverables across the development portfolio, and support efficient resource planning.
- Participate in project meetings, facilitate cross-functional communication, and coordinate study-related activities to maintain momentum across multiple drug development programs.
- Identify risks, discrepancies, and opportunities to improve study operations, documentation practices, data management, and collaboration with external partners.
- Support the advancement of preclinical candidates by ensuring that study outputs are accurate, complete, and available to inform scientific decisions and subsequent development milestones.
- Bachelor's or Master's degree in Toxicology, Pharmacology, or a related scientific discipline.
- At least six years of experience in the biotechnology or pharmaceutical industry, with hands-on involvement in nonclinical toxicology, safety pharmacology, ADME/DMPK studies, and collaboration with CROs or external development partners.
- Strong understanding of biological sciences, nonclinical research methodologies, toxicology study design, and the operational requirements of preclinical drug development.
- Demonstrated ability to coordinate multiple concurrent studies, manage competing priorities, monitor timelines, and ensure the timely delivery of scientific data and study documentation.
- Experience managing CRO relationships, coordinating statements of work, supporting protocol and study report reviews, and collaborating with multidisciplinary scientific teams.
- Familiarity with relevant global regulatory requirements and quality standards governing nonclinical research, including FDA, EMA, and ICH guidelines.
- Experience contributing to Investigational New Drug (IND) or Clinical Trial Application (CTA) submissions is preferred.
- Background in central nervous system (CNS) research, neuroscience, sleep-wake disorders, rare diseases, or related therapeutic areas is an advantage.
- Proficiency with scientific data analysis software, databases, and data management systems, along with the ability to learn new technologies and digital tools quickly.
- Excellent written and verbal communication skills, active listening, negotiation abilities, and interpersonal skills to build effective relationships with CROs and internal stakeholders.
- Strong organizational skills, meticulous attention to detail, and the ability to maintain accurate records while managing complex study activities.
- A proactive, adaptable, and solutions-oriented mindset, with the ability to navigate ambiguity, address unexpected challenges, and translate ideas into practical improvements.
- Comfort working in a fast-paced, matrixed biotechnology environment, with a collaborative approach and a strong commitment to scientific integrity, quality, and continuous learning.
- Genuine curiosity and motivation to contribute to innovative research programs with the potential to improve patient outcomes.
- Annual base salary: $129,000–$231,000, depending on qualifications, experience, skills, and geographic location.
- Performance-based incentives: Eligibility for a company bonus based partly on organizational and individual performance.
- Retirement benefits: Access to a company-sponsored 401(k) plan and pension benefits, subject to applicable eligibility requirements.
- Healthcare coverage: Eligibility for medical, dental, vision, and prescription drug benefits.
- Flexible benefits: Access to eligible flexible benefit programs, including healthcare and dependent care options.
- Insurance protection: Life insurance and death benefits, subject to the applicable plan provisions.
- Paid time off and leave: Vacation benefits and access to eligible leave programs.
- Well-being and employee support: Employee assistance programs, fitness benefits, and employee clubs and activities.
- Remote work opportunity: A remote position based in the United States, with the opportunity to collaborate with scientific experts and external research partners.
- Professional growth: Opportunities to deepen expertise in nonclinical development, study operations, regulatory compliance, and cross-functional program management.
- Meaningful scientific impact: The opportunity to contribute to the development of innovative medicines and support research aimed at addressing significant unmet medical needs.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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