Director, Clinical Operations

Hybrid: Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday.

POSITION OVERVIEW

This position is responsible for the strategic planning, financial oversight, and end-to-end execution of clinical trials, while ensuring compliance with regulatory, quality, and internal standards. This role oversees CROs and other external vendors, manages cross-functional study teams, supports data integrity, and drives operational efficiencies to ensure studies are delivered on time, within approved budgets, and with high quality.

RESPONSIBILITIES

Key responsibilities include:

Clinical Trial Strategy & Management

• Formulate operational execution strategies for clinical programs spanning Phase I–IV trials.
• Is accountable for the operational delivery of clinical trials, from protocol development through completion of the clinical study report.
• Own the development, maintenance, and adherence to integrated study timelines and milestones.
• Proactively identify and interpret clinical trial risks and implement mitigation strategies/corrective actions to address them.
• Drive study-level site selection and patient recruitment strategies.
• Determine drug supply assumptions for clinical trials and ensure trial sites have adequate drug supply.

CRO & Vendor Oversight

• Lead the identification, selection, and oversight of CROs, other external clinical vendors, and trial sites to ensure clinical trials are delivered on time, within approved budgets, and to expected quality standards.
• Serve as the primary oversight contact for strategic CRO and vendor partnerships.
• Lead contract and budget negotiations for CROs and other clinical vendors.
• Track metrics and performance to hold CROs and other clinical vendors accountable to financial and operational expectations.
• Manage clinical trial budgets and forecast costs across programs.

Compliance & Quality Assurance

• Develop or assist in developing/reviewing clinical protocols, investigator brochures, clinical development plans, clinical portions of regulatory submissions, and other key study-related documents.
• Ensure study plans, case report forms, tables, listings, figures, and clinical study reports are consistent, complete, accurate, and aligned with study objectives and regulatory requirements.
• Ensure compliance with clinical protocols, study plans, GCP, ICH, FDA, and other applicable regulatory requirements during clinical trials.
• Maintain an ongoing state of inspection-readiness across trial master files and study documentation.
• Lead the development, review, and continuous improvement of clinical SOPs and operational processes to support compliant, efficient, and inspection-ready clinical trial execution.

Team Leadership & Cross-Functional Alignment

• Promote alignment across functions by collaborating with internal stakeholders and serving as a core member of the cross-functional study team.
• Provide direction, guidance, feedback, and mentoring to external partners, consultants, contractors, and study team members, as appropriate.
• Effectively influence and ensure seamless, two-way communication and information sharing with internal and external stakeholders (e.g., CROs and trial sites) to ensure well-coordinated team dynamics and study execution.

REQUIRED LEADERSHIP BEHAVIORS 

At Collegium, how we achieve results is just as important as what we achieve. Our Leadership Behaviors define how we work, collaborate, and succeed as we continue to evolve as an organization.

We group these behaviors into three pillars:

• HEAD
• Think Entrepreneurially         
• Take Decisive Action
• Drive Results
• HEART
• Communicate Effectively
• Enable High Performance
• Collaborate with Purpose
• GUTS
• Take Smart Risks
• Be Tenacious About Change
• Compete to Win

Successful candidates will demonstrate these behaviors through their ability to challenge the status quo, build strong relationships, drive results, embrace change, and contribute to a high-performance culture.

QUALIFICATIONS

• B.A. or B.S. with at least 8 years of clinical trial experience in a pharmaceutical or biotechnology company, including experience leading or overseeing clinical trial execution
• Expertise in clinical operations, with in-depth understanding of FDA regulations and ICH-GCP guidelines governing the conduct of clinical trials
• Expertise in budgeting, financial tracking, and contract negotiation
• Strong organizational, problem-solving, and operational management skills
• Ability to communicate effectively, both verbally and in writing, across various levels of the organization
• Proven ability to work collaboratively and effectively in a cross-functional environment
• Flexibility to adapt to changing program and organizational needs
• Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) and EDC systems required