Senior Director, Clinical Operations

Position Summary

The Senior Director, Clinical Operations will provide strategic and operational leadership for the planning and execution of assigned early-stage clinical development programs across Aditum Bio's 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.

Position Responsibilities

Program Leadership

• Lead clinical operations for multiple early development programs (clinical pharmacology and Phase I/II) across Aditum Bio's portfolio companies.
• Develop operational strategy aligned with program and portfolio priorities, building and pressure-testing scenario plans across timeline, cost, enrollment, 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, enrollment planning, and risk mitigation.
• Ensure studies are delivered on time, within budget, and to the highest quality standards.

Cross-Functional & Vendor Leadership

• 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.

People & Innovation

• 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.

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• At least 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.

Pay and benefits

The range for this full-time position is $275,000 - 285,000, plus a target bonus, equity compensation and benefits including medical, dental, vision, and 401k. Our salary ranges are determined by role, level and location. The range displayed on our postings reflects the minimum and maximum for new hire salaries. Within the range, individual pay is determined by interview performance, job-related skills, experience and relevant education and training. Please note the range reflects base salary and does not include target bonus, equity or benefits.