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RAPT Therapeutics · 1 month ago

Associate Director, Clinical Operations

SOUTH SAN FRANCISCO, California, United States

Full-time

Hybrid

Lead/Staff, Director/Executive

$189K/yr - $209K/yr

10+ years exp

RAPT Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapies. The Associate Director Clinical Operations will lead cross-functional teams overseeing clinical trials, ensuring compliance with protocols and regulatory requirements while delivering high-quality clinical trial data on time and within budget.

BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics

Responsibilities

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 Development Team and Core Team (in collaboration with Clinical Operations representative on each team)

Communicate Development Team and Core Team recommendations and decisions to SET (in collaboration with Clinical Operations representative on each team)

Escalate to Development Team and 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 each 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 Project 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

Qualification

Clinical trial managementGlobal clinical trialsImmunology experienceVendor managementClinical operations experienceStudy start-up activitiesLeadership skillsCommunication skillsTeam collaborationProblem-solving skills