Senior Director Clinical Operations

Avetix Bio; Boston (MA); On-site; USD 260,000 - 380,000; Full time

Job summary

Avetix Bio seeks a Senior Director, Clinical Operations to provide strategic and operational leadership across early-stage clinical development programs, including clinical pharmacology studies and Phase I/II patient trials. You will partner with portfolio company leadership and cross-functional teams to deliver high-quality trials on time and within budget in a lean biotech incubator setting.

You will build scalable operational capabilities, oversee CRO and vendor performance, mentor staff, and

Qualifications

• 10+ years in clinical operations within biotech/pharma/CROs.
• Experience leading early-stage pharmacology and Phase I/II studies.
• Proven CRO/vendor governance, budget, and quality oversight.

Responsibilities

• Lead clinical operations for multiple early development programs across companies.
• Develop operational strategy aligned with program priorities, including timeline, cost, enrolment, and risk models.
• Serve as a trusted partner to executive leadership and cross-functional teams.
• Study Execution: lead studies from protocol development through closeout, driving global operational strategy and risk mitigation.
• Oversee CRO/vendor lifecycle, budgets, timelines, forecasts, resources, and performance.
• Quality & Continuous Improvement: ensure compliance with ICH-GCP and global regulations while maintaining inspection readiness.
• Drive continuous improvement through scalable processes, SOPs, and best practices.
• Develop and mentor clinical operations staff and external resources.
• Champion innovative approaches to trial execution including digital technologies and AI-enabled analytics.

Skills

Clinical operations leadership

Global trials

CRO/vendor oversight

Budget accountability

ICH-GCP compliance

Regulatory knowledge

Enrollment modeling

Strategic planning

Stakeholder influence

Digital/AI analytics

Job description

The Senior Director, Clinical Operations will provide strategic and operational leadership for the planning and execution of assigned early-stage clinical development programs across a portfolio of biotechnology companies. Reporting to the SVP, Clinical Development Operations, this individual will independently lead the clinical operations strategy and execution for assigned programs spanning clinical pharmacology studies (first-in-human, SAD/MAD, PK/PD, drug-drug interaction) and Phase I/II patient studies, partnering closely with portfolio company leadership and cross-functional teams to deliver high-quality clinical trials on time and within budget. The Senior Director will play a critical role in building scalable operational capabilities across the portfolio, overseeing CRO and vendor performance, mentoring clinical operations staff, and helping establish best practices across the portfolio. This role requires a collaborative leader who is equally comfortable serving as program lead and, where portfolio needs require it, as the study lead, developing operational strategy and rolling up their sleeves in a lean, fast-paced biotech incubator environment.

Responsibilities

• Lead clinical operations for multiple early development programs (clinical pharmacology and Phase I/II) across companies.
• Develop operational strategy aligned with program and portfolio priorities, building and pressure-testing scenario plans across timeline, cost, enrolment, and risk to inform program- and portfolio-level decisions.
• Serve as a trusted partner to executive leadership and cross-functional teams.
• Study Execution
• Lead studies from protocol development through closeout, driving global operational strategy, feasibility, enrolment planning, and risk mitigation.
• Ensure studies are delivered on time, within budget, and to the highest quality standards.
• Lead cross-functional study teams and own the CRO and vendor lifecycle (e.g., selection, contract scope, oversight, and ongoing performance) that drive execution.
• Oversee study timelines, budgets, forecasts, resources, and vendor performance.
• Quality & Continuous Improvement
• Ensure compliance with ICH-GCP and applicable global regulations while maintaining inspection readiness.
• Drive continuous improvement through scalable processes, SOPs, and operational best practices.
• Develop and mentor clinical operations staff and external resources through direct or matrix leadership.
• Champion innovative approaches to trial execution, including digital technologies, decentralized trials, and AI-enabled operational analytics.

Required Skills

• 10+ years of progressive clinical operations experience within biotechnology, pharmaceutical, or CRO organizations, including leadership responsibility for early-stage clinical programs.
• Demonstrated success leading the operational execution of both clinical pharmacology studies (first-in-human, SAD/MAD, PK/PD, drug-drug interaction, food effect) and Phase I/II patient studies, including global and multi-center trials, with a clear emphasis on early development.
• Significant experience overseeing CROs and external vendors, including governance, performance management, quality oversight, and budget accountability.
• Strong understanding of clinical development strategy and the operational considerations associated with early-stage drug development.
• Hands-on experience with global operational strategy: country and site selection, feasibility assessment, enrollment modeling, and scenario planning to support program-level decision-making.
• Proven ability to lead multiple concurrent clinical programs while effectively balancing competing priorities in a fast-paced environment.
• Deep knowledge of ICH-GCP, FDA, EMA, and other applicable regulatory requirements governing clinical research.
• Experience managing clinical trial budgets, resource planning, forecasting, and operational risk management.
• Demonstrated success building collaborative relationships across Clinical Development, Biometrics, Regulatory, Quality, and executive leadership.
• Excellent leadership, communication, and negotiation skills, with proven ability to influence and align senior stakeholders, including portfolio company executives, CMOs, investigators, and CRO partners, without direct authority.
• Track record of introducing new technologies, tools, or ways of working within clinical operations, and of leading the change management required for adoption.
• Comfortable operating in a lean biotech incubator model where strategic leadership is paired with a hands-on, execution-focused approach, including the willingness to serve as both program lead and study lead as portfolio needs dictate.