Senior Director, Clinical Operations: Early-Stage Biotech

Aditum Bio; Cambridge, Oakland (MA, CA); On-site; USD 275,000 - 285,000; Full time

Job summary

Aditum Bio is seeking a Senior Director, Clinical Operations to lead strategic and operational planning for assigned early-stage clinical development programs across its biotechnology portfolio.

Reporting to the SVP, Clinical Development Operations, this role will independently lead clinical operations strategy for first-in-human and Phase I/II studies, partnering with portfolio leadership and cross-functional teams to deliver trials on time and within budget.

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• 10+ years progressive clinical operations experience within biotech/pharma/CROs including leadership responsibility for early-stage programs.
• Proven success leading operational execution of clinical pharmacology studies (FIH, SAD/MAD, PK/PD, DDI, food effect) and Phase I/II trials.
• Significant experience overseeing CROs and external vendors, including governance, performance management, quality oversight, and budget accountability.
• Strong understanding of clinical development strategy and operational considerations for early-stage drug development.

Responsibilities

• Lead clinical operations for multiple early-development programs across portfolio companies.
• Develop operational strategy aligned with program priorities, building scenario plans for timeline, cost, enrollment, and risk decisions.
• Lead studies from protocol development through closeout, driving global strategy, feasibility, enrollment planning, and risk mitigation.
• Ensure studies are delivered on time, within budget, and to high quality standards.
• Oversee CRO/vendor lifecycle including selection, scope, oversight, and ongoing performance; manage timelines, budgets, forecasts, resources.
• Ensure regulatory compliance (ICH-GCP, FDA, EMA) and inspection readiness.
• Drive continuous improvement via scalable processes, SOPs, and best practices.
• Mentor clinical operations staff and external resources; balance program leadership and study lead roles as needed.
• Champion innovative trial execution approaches, including digital technologies, decentralized trials, and AI-enabled analytics.

Skills

Leadership

Clinical Ops

Program Mgmt

Budget Mgmt

Regulatory

Education

Bachelor's in science

Advanced degree preferred

Tools

GxP Systems

Job description

Aditum Bio is seeking a Senior Director, Clinical Operations to lead strategic and operational planning for assigned early-stage clinical development programs across its biotechnology portfolio.

Reporting to the SVP, Clinical Development Operations, this role will independently lead clinical operations strategy for first-in-human and Phase I/II studies, partnering with portfolio leadership and cross-functional teams to deliver trials on time and within budget.