Director, Trial Optimization & Study Activation
Department: Clinical Operations
Employment Type: Full Time
Reference Number: 1739185
Job Description Summary
This management position will be responsible for developing and implementing strategies and operational methods to optimize clinical trial initiation processes. This role requires functional expertise leading an internal team to develop new approaches to streamline clinical trial processes and conduct in partnership with CROs. This role will be the single point of accountability for study start up and also the operations lead for networks and alliances. The role will establish and build the framework to support integration of novel enhancements and analogs to improve clinical trial start up performance and KPIs. 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 standards meet business needs and objectives as well as regulatory standards.
- Accountable for strategic and operational optimization of a portfolio of clinical studies with primary focus on the study concept and initiation phase
- Directly manage internal Study Start Up Associates working with CROs and sites to optimize and streamline trial initiation and site activation timelines
- Lead and drive specific study strategy in interactions with Site Networks and Alliances, hospital or university clinical research units, advocacy groups, and recruitment vendors
- Contribute to protocol timeline planning activities, feasibility assessment and recruitment and retention support
- For Site Networks/Alliances, work closely with internal team members including those managing the relationship, to advance joint goals and deliverables and promote overall health and success of the collaboration which includes but is not limited to:
- Study start up elements
- Adherence to unique operating models of networks/alliances including just in time models
- Management of operational escalations
- Data aggregation and reporting for accrual tracking, network/alliance KPIs and more
- Support internal teams with visibility to the alliance model, unique aspects and development of new processes as needed while ensuring internal alignment
- Interface closely with medical affairs on the aspects of the network relationship and with the partner as needed
- Ensure that network alliances are managed consistently, drive implementation of alliance management best practices, standard tools and approaches where feasible
- Responsible for driving continuous improvement of study start up processes, functions and deliverables within Trial Optimization; May serve as Process Owner
- Establishes performance metrics for his/her teams and monitors these metrics in an effort to continually enhance capabilities and improve overall quality and timelines
- Manages resources to ensure portfolio needs are appropriately supported and study start up workload is balanced
- Provide vision, leadership, oversight, mentoring and coaching to Study Start Up Associates
What is Required
- Bachelor or Master of Science degree in medical/pharmaceutical/biological discipline
- At least 10-12 years of experience in the conduct of clinical trials and expertise in business process analytics and continuous improvement
- Direct experience in leading and managing oncology clinical trials, and in accelerating clinical study start up
- Demonstrated experience optimizing workflows involved in site selection, IRB/IEC submissions/approvals, site essential document processing, contract and budget negotiations, and enrollment
- Experience directly leading an organization and or colleagues in the same discipline
- Demonstrated expertise in designing and implementing measurable mitigations throughout the life of a clinical trial, and specifically in the study start up arena
- In depth knowledge of regulatory guidelines and ICH/GCP
- Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
- Demonstrated project management and cross-functional team leadership experience
- Strategic thinking and targeted problem-solving 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 KRASG12C 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 KRASG12D 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.