Director/Senior Director, Clinical Operations (Boston, MA)

Director/Senior Director, Clinical Operations (Boston, MA)

Summary:
As the Head of Clinical Operations, you will lead the clinical operations strategy and oversee clinical studies, driving industry-leading execution speed and quality. As a key functional leader and subject matter expert, you will collaborate with cross-functional program teams to achieve departmental and corporate goals.

Responsibilities:

• Lead strategic planning and daily study operations, focusing on site oversight from startup to closeout, patient enrollment, monitoring, compliance, and data flow with clinical sites, CROs, and vendors.
• Develop and implement global operations strategies with Clinical Development to optimize timelines while ensuring high quality and integrity.
• Collaborate with cross-functional teams to deliver clinical studies on time and within budget, ensuring quality in line with protocols, ICH GCP, regulatory guidelines, and patient safety.
• Manage clinical CROs, acting as the primary contact to identify and resolve issues, ensuring adherence to agreements, timelines, and quality standards.
• Build and maintain strong relationships with global investigators, clinical site staff, and vendors.
• Generate reports to communicate study progress and key metrics to Leadership and program teams.
• Partner with Finance and vendors to maintain accurate budgets and cost tracking for each clinical study.
• Contribute to preparation and review of key study documents, including protocols, informed consent forms, case report forms, and clinical study reports.
• Oversee the collection and analysis of clinical trial data, ensuring data accuracy and integrity.
• Participate in creating and updating clinical operations SOPs and coordinate with Quality Assurance for site and vendor audits.
• Hire, train, and develop the Clinical Operations team, fostering a culture of collaboration, accountability, and continuous improvement.

Requirements:

• BA/BS in a scientific discipline, with 10-12+ years of experience in clinical operations within pharma or biotech (experience with small to medium-sized companies preferred).
• Broad knowledge of biopharmaceutical drug development, including ICH and GCP guidelines and regulations.
• Preferred experience in immunology/inflammation clinical development.
• Strong experience managing collaborations with CROs, vendors, and external organizations, with experience in global clinical trial implementation.
• Excellent interpersonal skills and ability to build relationships with key stakeholders, along with conflict management and negotiation skills.
• Proactive mindset with strong leadership, teamwork, influence management, organizational skills, and the ability to work independently.
• Proficiency in project management practices, project planning, goal setting, prioritization, and time management.
• Ability to thrive in a dynamic, fast-paced biotech environment.
• Willingness to travel as required.

This is a full time position.