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Kura Oncology, Inc. · 4 months ago

Senior Clinical Trial Leader

Boston, MA

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

Kura Oncology is a clinical-stage biopharmaceutical company dedicated to advancing precision medicines for cancer treatment. They are seeking a Senior Clinical Trial Leader to manage the operational aspects of clinical trials, ensuring that project milestones are met and that trials adhere to compliance standards.

BiopharmaBiotechnologyGeneticsHealth CareMedicalOncologyPrecision Medicine

Comp. & Benefits

Responsibilities

Responsible for the planning and management of the operational aspects of clinical trials, including CRO and vendor management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company goals

Collaborate with internal and external team members for the planning and execution of clinical trials

Accountable for coordination of planning, initiation, completion, and reporting of clinical study protocols within or across programs from team endorsement to reporting

Ensure clinical trials meet time, quality, and cost targets consistent with the overall Clinical Development Plan

Lead the development of and provide input into study-related documents, including ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, etc. Also performs review and provides strong operational input in the development of clinical trial protocols and CSRs

Contribute to department documentation development, such as the development and writing of Standard Operating Procedures (SOPs)

Collaborate with Legal & Clinical Contracting & Outsourcing (and others, as needed) on the development and management of study specific agreements/budgets (i.e., non-disclosure agreements, clinical trial agreements, clinical research organization agreements, etc.)

Organize and manage project timelines and budgets; help ensure project deliverables are on time and within budget and amended accordingly

Provides leadership and contributes to all operational aspects of the trial budget, including forecasts to ensure delivery within the business financial standards

Oversee the conduct of studies and ensure studies are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures

Monitor and visit clinical study sites as needed

Track, collect, and review clinical documentation for clinical trials

Complete other duties as assigned by the manager

Key contributor to the development of annual trial/project objectives and communicating to relevant line management and Clinical Strategy Team (CST)

Serves as the key CST point of contact for the trial

Accountable for the successful preparation and presentation of operational content at key leadership discussions (CST, GPT, SLT, etc.)

Ensures strong oversight, review, and delivery of trial/project CAPAs in order to meet corporate compliance standards and timelines

Accountable for partnering with CRO in audit responses and addressing quality issues

Filters, prioritizes, analyzes, and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges

Ensures inspection readiness application for all assigned clinical trials

Manages projects/work streams with high complexity, risk, impact, and reach. Manages large-sized global clinical teams with members also from outside the direct working environment

Coordinates stakeholders from closely related areas and beyond

Demonstrates skills in successfully leading international teams in the matrix organization and directs, influences, and motivates people; creates and leads a positive working climate

Develop and lead operational and therapeutic area training for internal and external study team members

Directs multiple studies in parallel and/or be called upon for program management duties

Exhibits Subject Matter Expert level understanding of multiple functions and functional processes

Accountable for successful project execution including definition of milestones and clarification of project scope

Receives minimal guidance and works independently

Acts as a senior advisor and mentor within the team and beyond and serves as best practice resource within own discipline or as technical expert on cross functional teams or projects

Qualification

Clinical trial managementCRO oversightGCP knowledgeOncology experienceProject managementInterpersonal skillsDocumentation skillsCommunication skillsMentoring abilityOrganizational skills