Director, Clinical Operations — Oncology Trials

Generate Biomedicines; United States; On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Annual Bonus

Equity Compensation

Benefits Package

Job summary

Generate:Biomedicines, a clinical-stage company, seeks an Associate Director of Clinical Operations in the United States. The role leads planning and execution of early-stage oncology trials, interfacing with internal and external stakeholders to ensure high-quality data and on-time delivery.

The ideal candidate will manage site and CRO interactions, oversee startup, forecasting, data quality, and regulatory submissions while guiding a operations team through clinical development milestones.

Qualifications

• Minimum 8 years in clinical operations across at least 2 therapeutic areas, including oncology.
• Experience managing CROs and vendors in US and international trials.
• Understanding IND to NDA drug development phases and study delivery.

Responsibilities

• Develop clinical operations strategy for each development program.
• Collaborate cross-functionally on protocols, safety reports, and CROs.
• Evaluate and select CROs and sites; manage vendor scope, contracts, and budgets.
• Develop SOPs and ensure GCP compliance.
• Monitor external performance and troubleshoot challenges.
• Coordinate study timelines with internal partners.
• Attend site initiation meetings and study calls.
• Oversee patient recruitment planning.

Skills

Clinical Operations

CRO Management

Site Initiation

Regulatory Submissions

Team Leadership

Job description

Generate:Biomedicines, a clinical-stage company, seeks an Associate Director of Clinical Operations in the United States. The role leads planning and execution of early-stage oncology trials, interfacing with internal and external stakeholders to ensure high-quality data and on-time delivery.

The ideal candidate will manage site and CRO interactions, oversee startup, forecasting, data quality, and regulatory submissions while guiding a operations team through clinical development milestones.