Description: 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. Kura Oncology was founded in 2014 and has offices in La Jolla, California and Cambridge, Massachusetts.
Vice-President, Clinical Operations – Cambridge, MA
ESSENTIAL JOB FUNCTIONS:
- Direct clinical operational management of the Company’s clinical development programs and projects.
- Responsible for strategically planning clinical trials, resourcing, and providing oversight/execution to achieve program objectives and high-quality deliverables within established timelines and budgets.
- Provide strategic planning expertise; advise on operational components and ensure operational feasibility of clinical development plans and scenarios.
- Implement processes and build a Clinical Development Operations organization including resource planning and FTE allocation to successfully plan and conduct multiple clinical trials in early to late stage to achieve corporate objectives.
- Responsible for ensuring operational excellence in our clinical stage programs by applying high industry standards, policies, systems, and processes across all trials. Responsible for clinical trial budget management.
- Management and supervision of Clinical Operations functions and colleagues including Clinical Project Management, Data Management, Medical Writing, Regulatory Operations, Database Management, Medical Writing, Vendor Management, and Clinical Contracts/Budget Management.
- Responsible for recruiting, training, mentoring and retaining a top-tier clinical operations, data management, medical writing and regulatory operations team to achieve program objectives.
- Develop and implement resource management and trial metric tracking tools and establish performance goals by role. Develop and maintain systems for effectively managing service provider relationships. Provide oversight of clinical drug supply, vendor management and governance. Responsible for instituting a clinical Quality program in collaboration with other functions.
- Ensure Clinical Operations is compliant with company policies and procedures, as well as other applicable rules, guidelines and codes of practice required by regulators or law.
- Support Chief Medical Officer, clinical functions at Company, Executive Leadership and Board of Directors, as necessary.
- Contribute to investigator, regulatory and advisory board meetings.
- Complete other duties as identified or as deemed necessary.
- 15 or more years of pharmaceutical industry experience in oncology drug development, with 6 or more years of prior experience as a senior clinical operations manager or similar. Late stage development experience within or in collaboration with large biopharma required.
- Demonstrated expertise in the areas of clinical operations development and strategic planning; experienced with early to late stage clinical trials, and with the IND to NDA process.
- Experience developing, implementing and leading a broad range of clinical trials both in the U.S. and ex-U.S., building clinical operations infrastructure, including SOPs, and managing vendors.
- Experience with Clinical Operations line management, and mentoring and developing personnel.
- Extensive experience managing clinical trial budgets and clinical finance activities.
- Demonstrated leadership in a clinical operations role, effective organizational skills, and excellent verbal and written communication. Track record of program leadership and achievement of goals and deliverables.
- Ability and demonstrated record of decision making, influencing, leadership, and effecting change.
- Extensive academic and industry collaborative network.
- Experience working in global, alliance and/or partnership teams highly desirable.
- Travel estimated at 20%.
Kura Oncology offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to firstname.lastname@example.org