Director, Clinical Operations Study Lead
Department: Clinical Operations
Employment Type: Full Time
Reference Number: 1985881
Job Description Summary
The Director, Clinical Operations Study Lead will lead study operational strategy and planning, and oversee execution of clinical studies for assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan
- Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Mirati SOPs), on schedule and on budget
- Lead, direct and oversee CROs and other 3rd party vendors to achieve project goals
Leading Operational Strategy, Planning and Execution of assigned Clinical Trials
- Provides leadership, direction and oversight to CRO and 3rd party vendors to ensure study is progressing per plan and study issues are addressed and brought to resolution
- Develops Operational Strategy with a focus on ensuring accurate assumptions are applied and robust risk management plans are in place, and periodically updated during the life of the study
- Leads cross functional Study Team Meeting
- Single point of operational accountability for entire study lifecycle from protocol synopsis to CSR
- Presents at Quarterly Reviews with CRO and Mirati Leadership reviewing performance against metrics and other key performance indicators (KPIs)
- Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents
- Ensures operational feasibility, patient and site, is conducted
- Contributes to CRO selection; Ensures CRO/3rd party vendors are appropriately onboarded, trained and qualified
- Participates in country and site feasibility/selection process, with a focus on providing country operational insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy
- Accountable for study budget planning and management
- Validates study budget and ensures impacts are adequately addressed
- Provides alternative options/offsets in the case of significant budget increases
- Routinely communicates study status, issues and mitigation plans to manager and project team
- Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring
- Review, endorsement and validation of relevant study plans and timelines
- Attendance at CRO-led study meetings; Drive agenda topics and review meeting minutes for accuracy and compliance
- Review of outcomes/actions related to protocol deviations; primary purpose of review is to support the identification of trends across sites and/or the study
- Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies
- In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the operational plan for database lock and CSR
- Ensure studies are "inspection ready" at all times; May be involved in regulatory inspections by preparing for and/or attending the inspections
What is Required
- Bachelor's degree in one of the disciplines related to drug development or business required; Advanced degree desirable
- Minimum 12 years of relevant experience
- Broad experience in a Clinical Trial discipline executing all phases of a study from protocol synopsis to CSR
- Demonstrated project management and cross-functional team leadership experience
- Experience in understanding of key drivers impacting budgets and experience building a Clinical Trial Budget and managing project to budget
- Strategic thinking and targeted problem-solving skills
- Ability to identify, resolve & escalate issues
- Ability to leverage negotiation and conflict resolution skills to enhance team performance and delivery
- Ability to represent & communicate clearly to senior leaders, governance and external bodies
- Strong communication and interpersonal skills
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.