||Clinical Trial Leader, Clinical Operations
||March 12, 2020
|MANAGERIALLY RESPONSIBLE FOR:
ESSENTIAL JOB FUNCTIONS:
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.
- 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.
- Oversee all operational activities to ensure deliverables are prioritized and goals and objectives are met and/or changed accordingly.
- Accountable for coordination of planning, initiation, completion, and reporting of clinical 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 clinical protocols, ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, etc.
- Contribute to department documentation development, such as the development and writing of Standard Operating Procedures (SOPs).
- Collaborate with legal (and others, as needed) on the development and management of study specific agreements (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
- 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.
- Minimum B.A./B.S. degree in the science/healthcare field, a nursing degree, or equivalent combined education.
- At least 5 years of clinical research/trial experience or relevant work in the pharmaceutical/biopharma industry. Some experience in oncology preferred.
- Experience in CRO oversight is preferred.
- 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.
While performing the duties the employee is:
- constantly required to sit, and to reach to use computers and other office equipment
- occasionally stand for extended periods of time, up to four (4) hours/time.
- occasionally required to lift up to 10 pounds
- constantly required to view objects at close and distant ranges
- frequently required to communicate with others
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
Employee frequently works in a professional office environment and lab with lots of computer 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 Oncology is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package. To apply, please submit your resume to email@example.com