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About the Role

The Scientific Operations Leader provides operational leadership for outsourced research and development activities, serving as the operational hub for scientific study execution. This role partners closely with various internal departments and external contract research organizations (CROs) to ensure high-quality, on-time, and on-budget execution of research and development activities. The position involves overseeing operational planning, CRO management, budgeting, contracting, study tracking, and portfolio coordination, with potential for broader operational leadership and supervisory roles as the organization grows.

Responsibilities

Lead operational planning and execution for outsourced discovery and development activities.
Develop and continuously improve operational processes, workflows, and best practices.
Coordinate study planning and execution across multiple functional areas.
Monitor study progress, project costs, identify operational risks, and implement mitigation strategies.
Develop operational metrics, dashboards, and reporting tools.
Assist in building scientific operations capabilities, including supervision and development of future operations staff.
Identify, evaluate, qualify, and manage CROs and external scientific service providers.
Coordinate requests for proposals (RFPs), obtain and compare vendor quotations, and negotiate scopes of work.
Monitor CRO performance, deliverables, timelines, budgets, and scientific quality.
Serve as the primary operational liaison between internal scientific teams and external partners.
Develop and maintain strong strategic relationships with CROs and key external vendors.
Coordinate operational planning for nonclinical studies across various functional areas.
Develop and maintain integrated study schedules, milestone trackers, and timelines.
Ensure study documentation, protocols, work orders, reports, and operational records are complete and organized.
Facilitate cross-functional planning meetings and monitor execution of key project milestones.
Support technology transfer and operational coordination as programs transition from discovery into development.
Facilitate communication across multidisciplinary teams.
Present operational updates, portfolio metrics, timelines, and resource forecasts.
Support strategic planning activities, portfolio prioritization, and organizational resource planning.
Partner closely with Finance to develop study budgets, monitor expenditures, forecast spending, and reconcile invoices.
Track purchase orders, contracts, change orders, and vendor invoices.
Monitor budget performance and provide regular forecasting updates.
Identify opportunities to improve operational efficiency and optimize utilization of external resources.

Requirements

B.S., M.S., or Ph.D. in Life Sciences, Pharmaceutical Sciences, Biomedical Sciences, or a related scientific discipline.
Minimum of 8 years of experience in biotechnology, pharmaceutical, or CRO environments supporting scientific operations, research operations, project management, development operations, or related functions.
Demonstrated experience coordinating outsourced nonclinical research and development activities.
Experience identifying, selecting, negotiating with, and managing CROs and scientific service providers.
Strong experience managing study budgets, vendor quotations, purchase orders, contracts, timelines, and operational deliverables.
Working knowledge of drug discovery and early development, including DMPK, bioanalytical sciences, toxicology, pharmaceutical development, and IND-enabling studies.
Excellent organizational and project management skills with the ability to manage multiple complex programs simultaneously.
Strong interpersonal and communication skills with demonstrated success collaborating across multidisciplinary scientific organizations.
Experience developing operational processes, tracking systems, and performance metrics to improve organizational efficiency.
Proficiency with project management software, Microsoft Office applications, and budget tracking tools.
Experience supervising or mentoring scientific operations or project management staff.
Experience supporting regulatory submissions or IND-enabling development activities.
Familiarity with clinical development operations, clinical trial management, or clinical CRO oversight.
Experience implementing electronic project management, vendor management, or portfolio management systems.
Highly organized with exceptional attention to detail and operational excellence.
Strong problem-solving and decision-making skills with the ability to proactively identify and resolve operational challenges.
Collaborative leader capable of influencing multidisciplinary teams without direct authority.
Excellent relationship-building skills with internal stakeholders and external partners.
Adaptable and comfortable working in a rapidly evolving biotechnology environment.
Strategic thinker capable of building scalable operational infrastructure to support company growth.
Effective communicator with the ability to translate complex operational information into actionable business insights.

Skills

Project Management
Budget Management
Vendor Management
CRO Management
Operational Planning
Process Improvement
Risk Mitigation
Metrics Development
Relationship Building
Communication
Problem-Solving
Strategic Thinking
Adaptability

Experience Level

8+ years of experience

Education Level

B.S., M.S., or Ph.D. in Life Sciences, Pharmaceutical Sciences, Biomedical Sciences, or a related scientific discipline

About the Company

Working in a dynamic biotechnology environment.