Senior Vice President, Clinical Development Operations

Location: Boston Area (on-site presence required)

Reports To: Chief Medical Officer

Position Overview

Our client is a clinical-stage, platform-based biotechnology company advancing a novel approach to drug discovery and development. As programs move forward and the organization scales, the company is seeking a Senior Vice President, Clinical Development Operations to lead and integrate the operational execution of its clinical development strategy.

This is a player-coach role for a senior leader who combines hands-on execution with strategic oversight. The SVP will bring deep experience in Clinical Operations, along with meaningful exposure to Data Management, Clinical Science, and/or Development Operations, and will work closely with internal teams and external partners to ensure programs advance with speed, rigor, and clarity.

The role is based in the Boston area and requires regular on-site presence to support close collaboration with scientific and clinical leadership.

Key Responsibilities

Clinical Development Operations Leadership

• Lead end-to-end Clinical Development Operations across ongoing and planned global clinical programs.
• Act as the operational counterpart to Clinical Development leadership, translating strategy into execution.
• Operate as a player-coach, remaining hands-on while building and mentoring a high-performing team.

Cross-Functional Integration

• Oversee and integrate key development functions, including:
• Clinical Operations
• Data Management and clinical data flow
• Clinical Science execution support
• Development Operations (planning, governance, timelines)
• Ensure strong alignment across Clinical Development, Biometrics, Regulatory, Safety, and external partners.

Operational Strategy & Execution

• Convert development plans into executable operational timelines, resource models, and governance structures.
• Drive study planning, feasibility, enrollment strategy, site performance, and risk mitigation.
• Identify operational risks early and lead practical solutions to protect timelines and data quality.

CRO & Vendor Oversight

• Provide executive-level oversight of CROs and key vendors.
• Lead or support vendor selection, governance models, and performance management.
• Ensure external partners function as true extensions of the internal team.

Data Quality & Decision Support

• Ensure high-quality data generation, review, and reporting to support confident development decisions.
• Partner closely with Biometrics and Clinical Science to ensure data integrity and interpretability.
• Maintain inspection-ready operations aligned with ICH-GCP and global expectations.

Leadership & Communication

• Provide clear, actionable updates to executive leadership on operational progress, risks, and mitigation plans.
• Foster a culture of accountability, collaboration, and continuous improvement.
• Build scalable operational frameworks that support long-term growth.

Qualifications

• Advanced degree (MD, PhD, Master’s, or equivalent).
• Significant experience in Clinical Development Operations leadership within biotech or pharma.
• Demonstrated strength in Clinical Operations, plus meaningful experience in at least one of the following:
• Data Management
• Clinical Science
• Development Operations / Program Execution
• Strong knowledge of global clinical development and ICH-GCP.
• Proven ability to operate hands-on in fast-paced, high-science environments.
• Ability to work hybrid on site in the Boston area.