Director – Development and Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee program-level delivery for assigned early-phase oncology studies.

• Ensure that programs achieve key milestones, adhere to timelines, and maintain quality standards.

• Act as a senior resource in clinical operations for assigned programs.

• Assist with activities at the CRO, vendor, and site levels.

• Engage in cross-functional study team meetings and contribute to decision-making processes.

• Monitor key deliverables and timelines while escalating risks or issues as necessary.

• Aid in preparation for inspections, ensure TMF quality, and support audit readiness activities.

• Review study documents, tracking tools, monitoring plans, and study manuals.

• Support compliance with GCP and adherence to SOPs.

• Maintain budget trackers, purchase order logs, accrual schedules, and spending forecasts.

• Review vendor invoices and address discrepancies with Finance and Development Business Operations.

• Provide operational cost inputs for clinical trial budget development.

• Track actuals against the plan and highlight variances to senior leadership.

• Maintain financial tracking tools at the study level and assist with portfolio-level budget reporting.

• Identify and implement improvements in clinical operations processes.

• Develop and maintain operational tools, templates, reference documents, SOPs, work instructions, and process guides.

• Participate in cross-functional working groups and operational meetings.

• Assist in the onboarding of new vendors, CROs, or team members.

⛳️ Requirements

• Bachelor's degree in life sciences, business, or a related discipline.

• At least 10 years of experience in clinical operations, development operations, or a comparable role in a pharmaceutical or biotechnology setting.

• Direct, hands-on experience managing the execution of clinical trials.

• Proven experience as a clinical operations lead or CTM on early-phase oncology trials.

• Responsible for study timelines, site management, vendor coordination, and TMF quality assurance.

• Experience in supporting clinical trial budget tracking, accruals, and financial review processes.

• Proficient in Excel and operational tracking tools such as Smartsheet.

• Ability to develop or enhance operational tools, templates, and process documentation in a cross-functional context.

• Strong understanding of ICH-GCP, GCP compliance requirements, and regulatory standards for clinical trials.

• Exceptional organizational, communication, and problem-solving abilities.

• Capability to manage multiple concurrent workstreams in a dynamic, lean biotech environment.

• Proficient in clinical trial systems such as EDC, CTMS, and eTMF.

• Proficient in Microsoft Office Suite.

• Previous experience in a lean or startup biotech environment is highly valued.

• Global trial experience is essential.

🏝️ Benefits

• Competitive salary.

• Comprehensive benefits package.

• Significant equity participation in a company nearing the public market.

• Fully remote work options.