VP Clinical Operations

Job Title: VP Clinical Operations

Job Number: 32985

Location: San Diego, CA

Job Description

The VP Clinical Operations will provide clinical and regulatory operational expertise and organizational leadership to support the company’s development programs. This position has responsibility and authority to manage the company’s clinical and regulatory operations activities while working closely with medical and CMC personnel, CROs and other external vendors and consultants.

This person leads the clinical operations team strategically and is responsible for resourcing and execution of the company’s clinical trials and compliance with ICH and other regulatory guidelines and industry practices. The position will provide strategic direction for, and executive oversight of, operational matters impacting the company’s clinical development programs, including trial planning, study/protocol design and development, execution within budget and timelines, quality and compliance. Responsibilities also include actively managing CROs and external vendors to ensure outsourced work is delivered per timelines and project specifications, while achieving quality expectations.

Provides strategic and operational guidance to ensure that trials are properly defined, planned, and executed across all clinical stage programs. Leads and manages all aspects of company’s clinical operations to ensure delivery of clinical operations effectiveness including development and management of the operational interface & relationship with the cross-functional team.

This person is also responsible for handling day-to-day regulatory activities such as filing IND Amendments, periodic and expedited safety reports and coordinating and preparing responses to requests for information from regulatory agencies. This position involves both high-level strategic planning as well as hands-on responsibilities to support the company’s pipeline.

Responsibilities

• Lead the clinical operations team and oversee the strategy, planning, resourcing, execution, and close out of clinical research activities and clinical trials, data collection activities and operations.
• Manages and mentor’s clinical operations and other company personnel (e.g., clinical development, clinical supply, clinical quality, etc) to foster collaborative decision making and support their career development. Implements a company-specific clinical team to support current and future clinical trials.
• Implements study protocols, data management systems, data monitoring and quality systems, and enable data analysis and data reports/publications.
• Oversees efficient and timely processing of documents to support clinical development activities such as confidentiality agreements, clinical trial agreements, and vendor contracts and scopes of work.
• Oversees resourcing of and execution by clinical CROs and other clinical vendors contracted to conduct clinical trials sponsored by the company.
• Oversees adherence to protocols, clinical site monitoring, study-specific plans, and clinical quality audits. 
• Responsible for clinical trial files including contracts and ethics committees and maintains clinical inventory intended for distribution to investigational sites.
• Oversees the development, training, and updates to clinical operations Standard Operating Procedures (SOPs) for the organization.
• Develops, negotiates, and manages the clinical operations budget with CROs and other external vendors.
• Ensures effective external partnerships with investigators and study sites, clinical consultants, and other external vendors.
• Develops Clinical Quality Systems in conjunction with the Quality Group. This includes drafting and maintaining SOPs, ensuring CAPA implementation, inspectional readiness, and preparation for regulatory agency inspections.
• Develop and manage short- and long-range plans for the Clinical Operations Group that anticipates future needs (resources and technology) and maximizes the team’s ability to work efficiently and to deliver high quality clinical data to support regulatory filings.
• Author, review and/or edit clinical and regulatory documents (e.g., informed consents, Investigator’s Brochures, study materials, essential documents, presentations, IND sections, and reports) as necessary.
• Oversee and trouble-shoot clinical development program challenges, processes, activities and risk mitigation strategies pertaining to the conduct of clinical trials and key milestone deliverables, with company and external personnel.

Required Skills

• Bachelor’s degree in life sciences or business related. Master’s degree is a plus.
• A minimum of 15 years of experience with expertise in the areas of clinical operations development and strategic planning; developing, implementing, and leading early to late-stage clinical trials.
• Experience conducting clinical in oncology and respiratory diseases.
• In depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection.
• Experience in developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred.
• Expert knowledge of global regulatory and compliance requirements for conducting clinical research, including but not limited to FDA, ICH, EMA and industry standards.
• In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs.
• Demonstrated organizational and planning skills and independent decision-making ability.
• Strong organization and time management skills and ability to effectively manage and prioritize multiple projects simultaneously.

Compensation and Benefits:
Salary range: $220,000-250,000/year

Benefits:
Health Insurance (medical, dental, vision)
Life Insurance
Short- and Long-Term Disability
401(k)
Paid Time Off (PTO)
Annual bonus