Senior Clinical Trial Leader - Boston, United States - Kura Oncology, Inc.

Description

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

ESSENTIAL JOB FUNCTIONS:

General:

• 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.

Sr. CTL:

• 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

JOB SPECIFICATIONS:

• Advanced degree desirable; PM certification desirable
• Ideally 10 years clinical research experience with at least 5 years of direct trial management experience
• Some experience in oncology preferred.
• Experience in CRO oversight is required
• Manages large sized global clinical trial team
• Works with minimal or no supervision
• Ability to mentor junior staff
• Self-directed and proactive handles multiple complex tasks
• Strong organization, documentation, and communication skills.
• Excellent interpersonal skills: ability to collaborate across disciplines.
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
• Ability to travel up to approximately 30% of time.
• Hybrid on-site in Boston two days per week.

WORK ENVIRONMENT:

Employee frequently works in a professional office environment and lab with lots of computer/lab equipment, tools, and moderate amounts of noise and activity. Employee may occasionally be required to travel. The work environment is fast-paced and demanding. Off-shift, weekend and overtime duties may be required as assigned by the manager.

Kura's Values that are used for candidate selection and performance assessments:

• We work as one for patients
• We are goal-focused and deliver with excellence
• We are science-driven courageous innovators
• We strive to bring out the best in each other and ourselves

The Kura Package

• Career advancement/ development opportunities
• Competitive comp package
• Bonus
• 401K + Employer contributions
• Generous stock options
• ESPP Plan
• 20 days of PTO to start
• 18 Holidays (Including Summer & Winter Break)
• Generous Benefits Package with a variety of plans available with a substantial employer match
• Paid Paternity/Maternity Leave
• In-Office Catered lunches
• Home Office Setup
• Lifestyle Spending Stipend
• Commuter Stipend (Boston Office)
• Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more

Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of solid tumors and blood cancers. The company's diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology's approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts.

Kura's pipeline consists of three investigational drug candidates: ziftomenib, tipifarnib and KO-2806. Ziftomenib is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need. Ziftomenib is currently enrolling patients in a Phase 2 registration-directed trial (KOMET-001) in NPM1-mutant relapsed or refractory AML. Kura is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients with PIK3CA-dependent HNSCC. Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors. For additional information, please visit Kura's website at

Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.