Head of Clinical Trial Optimization
Department: Clinical Operations
Employment Type: Full Time
Reference Number: 1651230
Job Description Summary
This leadership position will be responsible for developing and implementing strategies to support systems integration enhancements for clinical trials. This role requires strategic orientation and functional expertise to lead the team and to develop new approaches to streamline clinical trial processes and conduct. This role will be the single point of accountability for robust clinical trial feasibility and use of analytics to drive and optimize site selection, a vertically integrated organization of dedicated study start-up professionals, vendor management, support of external collaborations, and other functions to facilitate increased operational efficiency. The role will establish the vision and build the framework to support the integration of novel enhancements and analogs to improve clinical trial performance and KPIs. You will develop, implement, and continuously enhance clinical research processes and capabilities to improve the quality and execution of Mirati's clinical trials. You will play a critical role in the success of Mirati's strategy to improve efficiencies and enable enhanced process capabilities for the delivery of clinical trials. You will partner with multiple internal groups within Integrative Sciences, Clinical Development, Regulatory Affairs, Pharmacovigilance, Biometrics, Clinical Operations, and Medical Affairs and work cross-functionally with other leaders to ensure systems integration standards meet business needs and objectives as well as regulatory standards.
- Lead organization in the delivery of high-quality process and operational excellence for clinical trials
- Establish trial site feasibility and selection processes using advanced analytics and predictive models
- Lead development of clinical and operational data-driven feasibility estimates, benchmarking assumptions, validated scenarios & accurate planning
- Develop and optimize processes and procedures for vendor management, clinical trial feasibility, study start-up activities, external collaborations, and clinical trial event management
- Develop and integrate new technologies, systems, and tools to enhance clinical trial conduct and overall performance
- Monitor benchmarks with industry peers and across other industries to establish and update best practices and KPIs
- Partner with CROs, Clinical Operations and Program Management to develop and deliver rapid, accurate, and robust assessments of program and country feasibility, oversight of site identification/site feasibility, and timing of key start-up and recruitment milestones
- Ensure appropriate communication and involvement across functions to create clear accountability for high quality, multidisciplinary processes
- Recognize and implement efficiencies identified through process improvements
What is Required
- Master's Degree in a scientific discipline. Doctorate degree preferred.
- At least 15 years of experience in biotech, CRO, academia, or pharmaceutical industry-leading oncology clinical trials
- Strong background showing progressive clinical trial and clinical development experience, including staff management
- Demonstrated experience with improving clinical trial KPIs
- Previous clinical trial outsourcing and associated governance leadership experience
- Ability to develop new clinical trial strategies using technology and systems (i.e. site feasibility, RWD, analytics etc.)
- Leadership and or staff experience in a study start up unit and/ or feasibility center of excellence preferred
- Strong written/verbal communication skills, detail-oriented nature
- Excellent leadership and influencing skills
- Demonstrated project management skills
- Ability to provide direction with cross-functional teams in a matrixed team environment
- Excellent computer skills including MS Office (Word, Excel, PowerPoint, Outlook)
About Mirati Therapeutics
Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design, and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRAS G12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRAS G12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability, and collaboration ground our work. These shared values are central to who we are, what we do, and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work-family
No matter the role, we are unified by our passion for helping patients and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.