Clinical Director Jobs

About The Position

Requirements

• BA/BS in life sciences or a health-related field required
• Minimum 12+ years of progressive clinical operations and/or development operations experience within the pharmaceutical or biotechnology industry.
• Demonstrated experience in clinical development programs and teams spanning early to late phase clinical development
• 5+ years of people management and leadership experience with a proven track record of building and developing high-performing teams.
• Demonstrated working knowledge of ICH/GCP guidelines, data management, clinical systems, statistical programming, medical writing, pharmacokinetics/pharmacodynamics, protocol design, and drug product development and distribution.
• Proficiency with MS Office Suite (Word, Excel, PowerPoint, Outlook, Project).
• Highly adaptable with the ability to thrive in a fast-paced, start-up or clinical-stage environment and develop creative solutions with limited infrastructure.
• Excellent interpersonal skills with strong oral and written communication abilities.
• Innovative, analytical, and highly organized with the ability to drive multiple projects to completion simultaneously.
• Proven experience working at the senior management level and recognized as a strong leader in a high-science organization.

Nice To Haves

• Experience with global project teams and ability to work across multiple time zones and languages preferred.

Responsibilities

• Ensures clinical trial objectives are aligned with clinical development strategy and overall corporate strategy.
• Generates progress reports and presents clinical program strategy and status updates to Senior Management.
• Contributes to business development activities and represents Development Operations on project and management teams.
• Directs the planning and execution of clinical trials across all phases of development, from early development through NDA/regulatory submissions.
• Accountable for clinical program and study timelines, budgets, and managing actual spend to approved budgets, including tracking actuals and communicating deviations.
• Oversees quality and risk management of clinical development programs, ensuring adherence to SOPs, GCP, ICH guidelines, and FDA regulations.
• Oversees the development and implementation of clinical trial systems and workflows (e.g., IRT/IXRS, central lab, eCOA) including design, specifications, and UAT.
• Oversees clinical supply forecasting, labeling/packaging, distribution, and chain of custody for clinical supplies.
• Oversees full-service CRO and vendor management activities, including RFP, vendor selection, scope of work development, performance management, and vendor governance.
• Works with internal and external medical, scientific, and operational experts to maintain awareness of industry standards and best practices.
• Authors and/or contributes to regulatory documentation and filings (e.g., IB, IMPD, IND) and correspondence with regulatory authorities and ethics committees.
• Contributes to the writing, review, and finalization of clinical study protocols, Investigator Brochures, and clinical study reports.
• Contributes to scientific publications and presentations.
• Provides leadership, mentorship, and direction to the Clinical Development Operations team; responsible for recruiting, developing, training, and retaining top talent.
• Ensures prioritization of activities and resourcing is aligned with clinical development program needs.
• Develops and maintains company SOPs, work instructions, and training for Clinical Operations activities.
• Constructively manages conflict within development teams and ensures timely resolution of issues.
• Fosters a collaborative, highly integrated, and innovative team culture.

Benefits

• health insurance
• paid time off
• retirement plan options