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Associate Director, Clinical Operations
Phathom Pharmaceuticals. Lead and oversee the execution of multiple clinical studies within assigned development programs .
Posted 11/6/2026full-timeBuffalo Grove • Illinois • United StatesSenior💰 $185,000 - $220,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in managing complex global clinical trials, ensuring compliance with ICH-GCP and FDA regulations, while effectively collaborating with cross-functional teams and external partners. Proven ability to oversee project management, budget forecasting, and operational strategy to achieve clinical development objectives.
Highest-signal resume keywords
Clinical Trial ManagementICH-GCP ComplianceRegulatory Affairs ExpertiseProject Management SkillsVendor Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical OperationsBudget ManagementRisk ManagementRegulatory ComplianceAudit ReadinessData ManagementEnrollment ProjectionsProtocol DevelopmentPerformance ManagementStrategic Initiatives
Soft Skills
LeadershipCommunicationCollaborationInfluencing StakeholdersOrganizational Skills
Industry Keywords
Pharmaceutical IndustryBiotechnologyCRO IndustryFDA RegulationsEU Clinical Trial RegulationsGlobal Clinical ResearchOperational ExcellenceClinical Development PlansCross-Functional TeamsContinuous Improvement
About the role
Key responsibilities & impact- Lead and oversee the execution of multiple clinical studies within assigned development programs
- Drive operational strategy and execution to support clinical development plans and overall program objectives
- Manage complex studies involving multiple indications, interim analyses, DSMBs, endpoint review committees, and global vendors
- Ensure studies are delivered on time, within budget, and in compliance with ICH-GCP, regulatory requirements, and company procedures
- Oversee project scope, critical path activities, timelines, milestones, and risk mitigation plans
- Select, manage, and oversee CROs and external vendors
- Lead vendor budget discussions, contract negotiations, and performance management activities
- Escalate and resolve operational challenges and vendor performance issues
- Partner with CROs to develop study management, enrollment, communication, monitoring, and risk management plans
- Develop and manage program budgets and forecasts
- Collaborate with Finance on forecasting, enrollment projections, and spend management
- Provide senior leadership updates on program status, risks, timelines, and financial performance
- Support operational due diligence for new compounds, partnerships, and business development opportunities
- Serve as the primary Development Operations representative for assigned programs
- Partner with Clinical Development, Regulatory Affairs, Medical Writing, Biostatistics, Data Management, and other stakeholders
- Participate in audit and inspection readiness activities and support regulatory interactions
- Contribute to departmental process improvements, strategic initiatives, and operational excellence efforts
- Contribute operational expertise to protocols, CSRs, Investigator Brochures, INDs, IMPDs, NDA and MAA submissions, and enrollment and risk management plans
- Support preparation for regulatory agency meetings and health authority interactions
- Provide guidance, mentorship, and support to Clinical Operations team members and cross-functional colleagues
- Contribute to department training, development initiatives, and resource planning
- Foster accountability, collaboration, quality, and continuous improvement
Requirements
What you’ll need- Bachelor's degree; preferably in a scientific discipline
- Minimum of 8 years of clinical/operations experience within the pharmaceutical, biotechnology, or CRO industry
- Experience managing complex, global clinical trials across multiple therapeutic areas
- Demonstrated success overseeing CROs, vendors, investigators, and external partners
- Strong understanding of ICH-GCP
- Strong understanding of FDA regulations and US CFR requirements
- Strong understanding of EU Clinical Trial regulations
- Strong understanding of global clinical research compliance standards
- Experience with regulatory inspections and audit readiness activities
- Excellent project management, organizational, and prioritization skills
- Strong written, verbal, and presentation communication abilities
- Proven ability to influence stakeholders and lead cross-functional teams in a matrix environment
Benefits
Comp & perks- Highly competitive medical, dental and vision coverage options with low monthly premiums
- Roth & Traditional 401(k) savings plan with annual employer match
- Long-term incentive equity compensation program
- Employee Stock Purchase Plan (ESPP)
- 16 weeks of paid parental leave for all new parents
- 4-week part-time Bridge-Back-to-Work Program
- Hybrid and Flex Working Arrangements
- Unlimited Time Off
- 17 paid company holidays in addition to a year-end winter shutdown period
- Annual Fitness & Wellbeing Reimbursement
- Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
- Company-provided short and long-term disability benefits
- Company-funded HSA plan
- Accident and Hospital Indemnity insurance
- Employee Assistance Program (EAP)
- Employee recognition program