Director, Clinical Trial Management
About The Position
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.
Requirements
- Bachelor’s degree in science/healthcare field, a nursing degree, or equivalent combined education.
- 10+ years of strong hands-on experience leading large, complex Phase 3 clinical trials preferably in oncology/hematology in US, Asia, Europe; or equivalent combination of training and experience.
- Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
- In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent verbal and written communication skills.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Flexibility to travel domestically and internationally as required.
- Experience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions.
- Proficiency with Microsoft Project
Nice To Haves
- Experience setting up clinical trials outside of US and Europe is a plus.
- Field monitoring and/or clinical data management experience preferred.
Responsibilities
- Leads the planning and execution of a complex, global clinical trial from start-up through close-out, in compliance with regulations/SOPs, within budget and timelines.
- Provides oversight and guidance to clinical operations personnel assigned to the clinical trial.
- Partners closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and other functions to ensure aligned and efficient trial execution.
- Establishes strong relationships with investigators and KOLs.
- Contributes to the development and review of key study documents including protocols, ICFs, monitoring plans, EDC specifications and statistical analysis plans.
- Contributes to the selection of vendors and CROs. Manages and oversees CROs, vendors, and other external partners to ensure high-quality performance and adherence to expectations.
- Develops, manages, and tracks clinical trial budgets, ensuring studies are delivered within approved financial parameters.
- Provides regular, clear updates on study status, risks, and milestones to senior leadership and key stakeholders.
- Proactively identifies operational risks and implements mitigation strategies to maintain timelines, quality, and compliance.
- Supports and facilitates execution of contracts, clinical trial agreements, and study budgets.
- Direct manager of approximately 1-2 direct reports.
- Provides expert input into the building of department infrastructure, including developing, training, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
- Drives the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
- Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.
- Complete other duties as assigned by the manager.
Benefits
- 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!
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
11-50 employees
