Director, Clinical Operations

$236,000 - $275,000/Yr

Aligos Therapeutics - South San Francisco, CA

Full-time - Senior

South San Francisco, CA

About the position

The Director of Clinical Operations will report directly to the Head of Clinical Operations and will be responsible for the operational implementation of one or more clinical trials. This individual will be a key member of a small clinical development team that is implementing a number of early-stage clinical programs evaluating multiple investigational drugs for the treatment for chronic hepatitis B, MASH, and SARS-Cov2.

Responsibilities

• The development and execution of high-quality, realistic, cross-functional, clinical trial plans using best practice management standards and methodologies
• The identification and selection of Service Providers (SPs) and investigational clinical sites
• The development of Requests for Proposals from Service Provider's
• The management of Service Providers including training and oversight, and for being the primary point of contact for SPs
• The drafting and coordination of reviews of study-related documents including protocols, informed consent forms, case report forms, monitoring plans, investigator brochures, and clinical study reports
• The development and maintenance of study timelines and study budgets
• The coordination of the review of data listings and oversight of the preparation of interim/final clinical study reports
• Contributing to the development of abstracts, presentations, and manuscripts
• Monitoring and tracking clinical trial progress and upkeep of status update reports
• Identification of program risks and development and implementation of mitigation strategies
• Set up of (e)TMF, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages
• Ensuring GCP compliance and inspection readiness are maintained throughout study conduct
• Performing Sponsor quality oversight of clinical investigational staff and SPs
• Performance of oversight of central laboratories and other ancillary vendors during start-up, conduct, and close-out
• Coordination with CMC regarding drug forecasting and supply of study drug to investigational sites
• Contribution to the development of clinical trial management best practice processes and SOPs
• Contributing to department initiatives to improve the efficiency and effectiveness of the Clinical Operations group
• Will be responsible for managing, mentoring and/or providing oversight for less-experienced Clinical Operations staff
• Will be responsible for helping to plan and implement professional development activities for any assigned team members

Requirements

• A minimum of a bachelor's degree and/or RN Degree is required
• A minimum of 10 or more years of clinical monitoring and clinical operations experience within a pharmaceutical, biotechnology, or contract research organization is required
• Prior experience of management and supervision of clinical operations personnel required

Nice-to-haves

• Experience of early clinical development, particularly with antiviral or anti-infectious disease compounds is preferred.

Benefits

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Short and Long Term Disability
• Health Savings Account (HSA)
• Flexible Spending Accounts (FSA)
• Critical Illness Insurance
• Accident Insurance
• Legal and ID Theft Insurance
• 401k plan
• Paid Time Off (PTO)
• Employee Stock Purchase Plan (ESPP)