Associate Director, Clinical Operations

PURPOSE OF JOB: The Associate Director Clinical Operations will provide day-to-day cross-functional leadership and oversight and support for RAPT clinical trials as assigned.  This cross-functional study leadership role involves direct oversight of one or more Study Execution Teams (SETs), as well as collaboration with external functional area / support staff and vendors, to ensure successful execution on the clinical strategy and delivery of high-quality clinical trial data on time and within budget. The suitable candidate will work under minimum supervision and contribute technical and operational expertise to achieve RAPT’s Clinical Development goals.

MAJOR DUTIES AND RESPONSIBILITIES:

The successful candidate will be responsible for providing oversight of in-house and outsourced clinical trial activities in the following areas:

• Leads the SET in support of the approved study consistent with the Clinical Development Plan or other Core Team endorsed parameters
• Propose and establish working groups in collaboration with relevant functional areas
• Oversee the initial development and continued updates for both the SET Risk Mitigation Plan and SET RACI
• Communicate SET recommendations and decisions to Core Team (in collaboration with Clinical Operations representative on the Core Team)
• Communicate Core Team recommendations and decisions to SET (in collaboration with Clinical Operations representative on the Core Team)
• Escalate to Core Team in an efficient and timely manner all issues that impact key deliverables/milestones, timelines, budgets, and resources (in collaboration with Clinical Operations representative on the Core Team)
• Ensure new SET members are oriented to the SET Charter as appropriate
• Meet with each SET functional representative at least quarterly
• Provide functional input and expertise as needed
• Leads the set-up and on-time execution of clinical study tasks, while ensuring the trial is conducted to RAPT quality standards and in compliance with the protocol, SOPs, ICH-GCP, and applicable regulatory requirements
• Ensures effective cross-functional collaboration to ensure delivery of the assigned activities to meet project milestones
• Leads identification, selection, contracting and management of study vendors/CROs and development of vendor scope of work (SOW)
• Leads the development and review of clinical study plans (Clinical Monitoring Plans, Data Management Plans, Safety Management Plans, Communication Plans, etc.), and other project/study-related documents including training materials, forms, logs, presentations, etc.
• May act as primary point of contact for assigned trial(s) for vendors, partners, investigational sites, and RAPT internal teams
• Participates in specification development, design, set-up and UAT of trial infra-structure systems (EDC, IRT, CTMS, eCOA, etc.) and demonstrates proficiency in the use, configuration and oversight of these systems to ensure operational readiness and data integrity throughout the study lifecycle
• Provides leadership and oversight of Clinical Operations staff assigned to work closely with RAPT Biomarker Team staff and external personnel (Central Labs, specialty labs, clinical trial study sites, etc.) on clinical laboratory activities including specimen management & logistics, data management, and issue identification and resolution
• Ensures effective collaboration with RAPT Clinical Drug Supply Manager and internal and external CMC / Supply Chain personnel to forecast investigational product, auxiliary medicinal products, and other study-critical materials, and to identify distribution, storage, and accountability requirements
• Ensures effective collaboration with RAPT Clinical Program Manager and Finance personnel to ensure accuracy and financial information related to clinical trial progress, including enrollment information, timeline status, and budget forecasts and updates
• Writes/Contributes to clinical trial protocols and protocol-associated documents including Informed Consent Forms and other documents as needed
• Coordinates/Performs in-house review of clinical data listings for completeness and accuracy and escalates issues to the vendor and RAPT internal team, as needed
• Manages clinical monitoring activities, overall site performance, and ensures compliance with Good Clinical Practices (GCP) and applicable regulations
• Ensures monitoring trip reports are reviewed and action items are followed to resolution; escalates critical issues and risks, as necessary
• Ensures ongoing review/oversight of TMF and other records as assigned
• Organizes and manages internal team meetings, investigator meetings, and other trial-specific meetings as required
• Other duties as assigned

EDUCATION REQUIREMENTS: 

• Bachelor’s degree required, preferably in a scientific discipline. Advanced degree preferred.  May consider a combination of experience and education in lieu of strict adherence to educational requirements

EXPERIENCE REQUIREMENTS: 

• Minimum of 10 years of clinical operations experience, including
• Recent experience leading global clinical trial(s) in immunology and/or dermatology
• Significant experience leading study start-up activities for global trials
• Proven track record of managing the full end-to-end spectrum of clinical trial activities
• Experience directly managing clinical vendors, including but not limited to CRO, eCOA, EDC, IRT, Drug Depots, etc.
• Minimum of 2 years managing direct reports or 4 years managing personnel in a matrix environment

OTHER QUALIFICATIONS:  

• Ability to work on-site at our South San Francisco office 3 days per week

California law requires pay information in job postings. The specific rate will depend on the successful candidate’s qualifications, prior experience, and other relevant factors. The estimated annual pay range for this position is $189,300 (entry-level qualifications) to $209,000 (highly experienced).

Salary : $189,300 - $209,000