Vice President, Clinical Development Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Assume primary responsibility for the operational planning, management, and execution of clinical trials aimed at generating clinical evidence.

• Propel performance against essential trial metrics, including site activation, patient enrollment, data quality, budget compliance, and alignment with corporate objectives and regulatory requirements.

• Design and implement optimized operational strategies to improve trial efficiency, decrease complexity, and expedite data delivery timelines.

• Actively engage in budget planning, financial forecasting, and resource allocation within the evidence generation operations unit to ensure peak performance.

• Work closely with Biostatistics and Data Management teams to guarantee the timely, accurate, and high-quality transfer of trial data into the clinical database, facilitating efficient data cleaning, analysis, and database lock.

• Collaborate closely and establish efficient workflows with cross-functional leaders to ensure that clinical trial data from all sources is accurately captured and reconciled.

• Lead, mentor, and cultivate a high-performing operations team proficient in managing a focused portfolio of clinical evidence generation studies.

• Act as the primary operational leader for evidence generation trial execution, ensuring strong alignment and communication with Clinical Development, Regulatory Affairs, Project Management, and other key stakeholders.

• Ensure that all evidence-generation trial activities are conducted in strict compliance with Good Clinical Practice (GCP), ICH guidelines, and global regulatory standards.

• Maintain a continuous state of inspection readiness for all evidence-generation clinical trials and assist senior leadership during regulatory authority inspections (e.g., FDA).

⛳️ Requirements

• A Bachelor’s degree in a scientific, life sciences, or healthcare discipline is required; an advanced degree (MS, PhD, PharmD) is preferred.

• Over 13 years of progressive experience in clinical trial operations within the pharmaceutical, biotech, or medical device sectors, with a specific emphasis on managing trials for clinical evidence generation.

• More than 5 years of experience in managing and building high-performing clinical operations teams.

• Extensive, demonstrable knowledge of GCP, ICH guidelines, and experience defending clinical data/sites during regulatory authority inspections (e.g., FDA).

• A proven history of successful collaboration with Biostatistics, Data Management, and Medical Directors to achieve timely database locks.

🏝️ Benefits

• We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.