Director of Clinical Operations (Hybrid) - CEDENT

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:

• Lead and oversee strategic planning, implementation, and execution of clinical trials across an immunology program, ensuring adherence to timelines, budget, and quality standards.

• Develop and manage comprehensive program project plans, including study protocols, clinical trial budgets, timelines, enrollment, and risk mitigation strategies.

• 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.

• Provide operational expertise and strategic input in developing Clinical Development Plans (CDP), supporting the overall clinical strategy for the program.

• Act as the primary point of contact for CROs and vendors, overseeing performance and ensuring compliance with agreements, timelines, and quality standards.

• Ensure all clinical trials comply with regulatory requirements, ICH-GCP standards, and company SOPs.

• Oversee data collection, analysis, and interpretation, working closely with Clinical Development, Biostatistics, and Data Management teams to ensure data accuracy and integrity.

• 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.

• 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:

• BA/BS, preferably in a health-related field; MA/MS in biological sciences, life sciences, nursing, or related field preferred.

• 10+ years of experience in clinical operations within the pharmaceutical or biotechnology industry.

• Experience in building and leading a team is a plus.

• Expertise in global regulatory and compliance requirements for clinical research, including US CRF, EU CTD, and ICH GCP.

• Proven ability to manage multiple competing priorities and adapt to changes.

• Strong communication, interpersonal, and problem-solving skills.

• Comfortable working in a fast-paced environment.