Associate Director, Clinical Operations

Generate Biomedicines

. Plan and execute early-stage clinical trials, initially focused on oncology programs .

Posted 9/21/2026full-timeRemote • United StatesSenior💰 $162,000 - $227,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical operations, particularly in oncology, with a strong focus on managing CROs, developing clinical strategies, and ensuring GCP compliance. Proven ability to lead teams, collaborate cross-functionally, and effectively communicate with stakeholders throughout the clinical trial process.

Highest-signal resume keywords

Clinical Operations ManagementCRO ManagementOncology ExperienceGCP ComplianceClinical Trial Strategy Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial PlanningData ManagementBudget ForecastingProtocol DevelopmentRegulatory SubmissionsVendor SelectionSOP DevelopmentPatient Recruitment PlanningStudy Timeline ManagementSite Management

Soft Skills

Effective CommunicationTeam LeadershipProblem-SolvingMentoringCollaboration

Industry Keywords

Oncology ProgramsClinical TrialsIND to NDA ProcessBiomarker-Selected StudiesPharma and Biotech ExperienceClinical Operations StrategyStudy Initiation MeetingsAnnual Safety ReportsInvestigator BrochuresClinical Study Reports

About the role

Key responsibilities & impact

Plan and execute early-stage clinical trials, initially focused on oncology programs
Interface with internal and external stakeholders to plan, execute, and problem-solve throughout clinical trials
Lead site- and CRO-facing interactions, including study start-up, drug and budget forecasting, and acquisition of high-quality clinical and translational data
Serve as clinical operations program lead for at least one program and associated studies
Lead a team of clinical operations staff
Develop clinical operations strategy for assigned development programs
Collaborate cross-functionally to develop protocols, annual safety reports, investigator brochures, clinical study reports, presentations, regulatory submissions, and publications
Evaluate and select CROs, sites, and other external collaborators; develop vendor scopes of work, contracts, quality plans, monitoring plans, and budgets
Develop and manage SOPs and ensure GCP compliance
Evaluate vendor performance, troubleshoot challenges, and recommend solutions
Develop and manage study timelines with internal partners
Attend and present at study site initiation meetings and study calls as appropriate
Plan and forecast patient recruitment
Manage or mentor Clinical Operations team members

Requirements

What you’ll need

Minimum 8 years of experience in clinical operations across at least 2 therapeutic areas, including oncology
Experience managing CROs and vendors in the US and international clinical trials
Experience in site initiation visits, site management, and data cuts for publication and regulatory requirements
Understanding of the drug development process from IND to NDA
Ability to communicate effectively and efficiently
Willingness to train other team members within and outside Clinical Operations
Experience in large Pharma and biotech and with biomarker-selected studies preferred but not required
Experience with at least one report preferred, but strong hands-on experience and a growth mindset will be considered

Benefits

Comp & perks

Annual bonus
Equity compensation
Competitive benefits package