Senior Director, Clinical Operations Lead
Department: Clinical Operations
Employment Type: Full Time
Reference Number: 1880965
Leader in the clinical operations function to oversee milestones and deliverables from protocol creation and related clinical trial activities to study completion, including study initiation, achievement of enrollment targets, maintenance of high-quality study data, data cleaning, database lock and clinical study report preparation.
- Active participant in developing clinical trial strategies and incorporating these into a Clinical Development Plan.
- Line management responsibilities include overseeing staff working in various functions at the study level
- Support development of SOPs and establishment of associated trainings together with subject matter experts, and ensure consistency, quality and compliance with global clinical standards.
- Oversee the preparation and management of clinical trial budgets, resources and timelines; identify and develop mitigation strategies for potential issues and resolution processes as appropriate
- Provide strategic direction for outsourcing, selection and oversight of CROs and vendors, and provide ongoing executive management to selected partners
- Coordinate closely and collaboratively with Drug Safety, Quality and Compliance, Regulatory, Technical Operations (Supply Chain), Finance and Medical teams to ensure operational excellence in clinical trial execution.
- Work with internal team members in the development and implementation of compliance programs for clinical trials, including SOPs; to ensure compliance with all domestic and foreign regulatory requirement governing the conduct of clinical trials of human subject. Experience in clinical trial audit activities
- Negotiate resource needs and allocation with line functions.
- Continuously monitor project progress, costs, resource allocations and timelines and implement corrective action if deviations occur; work with functions to develop contingency plans and drive their implementation when triggered.
- Lead the identification, evaluation and selection of clinical trial investigators and sites, including experience working with cooperative groups in multi-center trials as well as in investigator initiation studies.
- Perform ongoing assessment, evaluation and control of internal and external resources.
- Forecast resourcing requirements to meeting the needs of current and projected study activity.
- Partner with HR to recruit talent to meet business needs and foster department growth
- BS (Science degree) with 12+ years, MS/RN with 6+ years, MD or PhD with 5+ years of clinical development experience in industry setting.
- Oncology therapeutic area expertise preferred
- Broad and deep knowledge of clinical operations, clinical development, and clinical project management
- Experience with CRO management
- Expected competencies:
- Working knowledge of ICH/GCP guidelines
- Effective written/verbal communication (e.g. able to adjust style/contents to suit the audience/purpose)
- Ability to work independently as well as collaboratively in a multidisciplinary setting
- Ability to work well under pressure
- Ability to apply technical expertise and make sound decisions
- Ability to influence without authority
- Flexibility and willingness to adapt in a changing environment
- Ability to travel
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.