Overview

The Director will provide leadership to all operations functions assigned to the implementation of a clinical trial and represents clinical operations functions as a core member of the cross-functional team. This position is responsible and accountable for all operational activities within a clinical trial and ensures these activities are performed according to quality, schedule and cost standards as defined by senior management, executed contractual agreements, regulations, good clinical practice, and standard operating procedures (SOPs). Through appropriate leadership, direction and operational expertise, the Director will contribute to clinical operations strategies for specific projects and act as a key partner with internal and external stakeholders to ensure the effective implementation of these strategies.

Responsibilities

• Is accountable for operational delivery of clinical trials, from protocol generation through to completion of clinical study report.
• Oversee cross-functional alignment, collaborating with and influencing other cross functional colleagues; is a core member of the cross-functional team.
• Play a key role in identification, selection and oversight of CROs, other external clinical vendors, and trial sites, ensuring clinical trials are executed on time, within budget and with quality; assist with contract and budget negotiations.
• Proactively identify and interpret clinical trial risks, and implement mitigation strategies/corrective actions to address them.
• Effectively influence and ensure seamless, two-way communications and information sharing with internal and external stakeholders (e.g., CROs and trial sites) to ensure well-coordinated team dynamics and study execution.
• Develop or assist in developing/reviewing clinical protocols, clinical portions of regulatory submissions, clinical development plans, and other key study-related documents.
• Determine drug supply assumptions for clinical trials and partner with tech ops to ensure trial sites have adequate drug supply.
• Ensure uniform standards are used across all clinical trials in compliance with current regulations, ICH-GCP guidelines, and SOPs and consistent with clinical protocols.
• Manage internal and/or external people (e.g., contractors/vendors), providing feedback, mentoring, and/or guidance, as appropriate, on a regular basis.
• Uphold and consistently demonstrate Collegium’s Core Values.
• Contributes to the functional plans and delivers team goals.
• Communicates with gravitas/influence and makes personal connections.
• Identifies improvements in existing approaches and solves tough problems.

Qualifications

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