Director of Clinical Operations (Hybrid) (Boston, MA)

Director of Clinical Operations (Hybrid) (Boston, MA)

Summary:
The Clinical Operations Program Lead will be responsible for overseeing the strategic planning, implementation, and execution of clinical trials within a key immunology program. This role ensures trials are conducted according to project timelines, budget constraints, and quality standards. The Clinical Operations Program Lead will collaborate with cross-functional teams to support the clinical strategy, manage external vendors, and ensure compliance with regulatory and company standards.

Responsibilities:

1. Lead and oversee strategic planning, implementation, and execution of clinical trials across an immunology program, ensuring adherence to timelines, budget, and quality standards.
2. Develop and manage comprehensive program project plans, including study protocols, clinical trial budgets, timelines, enrollment, and risk mitigation strategies.
3. Collaborate cross-functionally with internal teams such as Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine, and Program Leadership to align on clinical trial objectives and milestones.
4. Provide operational expertise and strategic input in developing Clinical Development Plans (CDP), supporting the overall clinical strategy for the program.
5. Act as the primary point of contact for CROs and vendors, overseeing performance and ensuring compliance with agreements, timelines, and quality standards.
6. Ensure all clinical trials comply with regulatory requirements, ICH-GCP standards, and company SOPs.
7. Oversee data collection, analysis, and interpretation, working closely with Clinical Development, Biostatistics, and Data Management teams to ensure data accuracy and integrity.
8. Contribute to the preparation and review of clinical study documents, including the Investigator Brochure, IND applications, study protocols, clinical study reports, and updates for regulatory submissions.
9. Work with the Head of Clinical Operations to hire, train, and develop the Clinical Operations team, fostering a collaborative, accountable, and excellence-driven culture.

Requirements:

1. BA/BS, preferably in a health-related field; MA/MS in biological sciences, life sciences, nursing, or related field preferred.
2. 10+ years of experience in clinical operations within the pharmaceutical or biotechnology industry.
3. Experience in building and leading a team is a plus.
4. Expertise in global regulatory and compliance requirements for clinical research, including US CRF, EU CTD, and ICH GCP.
5. Proven ability to manage multiple competing priorities and adapt to changes.
6. Strong communication, interpersonal, and problem-solving skills.
7. Comfortable working in a fast-paced environment.