Director, Clinical Development Scientist
Department: Clinical Development
Employment Type: Full Time
Reference Number: 2441333
Job Description Summary
Collaborates with Clinical Development colleagues to efficiently design and effectively execute high quality clinical studies in close partnership with Clinical Operations. Your accountabilities include timely delivery of the protocol, clinical data review, and support of the appropriate interpretation and communication of data. As well as maintaining compliance with internal and external standards, mitigating risk and managing emerging clinical issues within the trial and being a contact for external investigators and internal study teams for questions relating to clinical/medical aspects of the protocol.
- In collaboration with the Medical Director, leads development and clinical/scientific execution of study protocols and amendments
- Ensures appropriate data review, interpretation of study results, and reporting in collaboration with other functional groups.
- Reviews and tracks emerging efficacy and safety data including adverse events and laboratory results, and keeps Medical Director informed of changes in the efficacy/safety as they occur and take action as appropriate
- Conducts medical monitoring and addresses medical inquiries (only if Medically Qualified individual)
- Works with the Medical Director to conduct routine safety reviews
- Contributes to study documents, including ICF templates, eCRFs and SAE report forms
- Supports development of clinical sections of regulatory documents, including investigator brochures, annual safety update reports, and clinical study reports
- Supports and interfaces with Clinical Operations and study level project team throughout trial conduct
- Collaborates with Medical Director to communicate study data results to colleagues, both internally and externally.
- Assists with preparation of various presentations, including meeting abstracts, posters, oral presentations and advisory boards
- Interprets, reports and prepares written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
- Assists with preparing responses to questions from Health Authorities and Ethics Committees
- Prepares and may present scientific/clinical information at SIVs and internal and external meetings
- Contributes to the clinical development strategy
- Works closely with Quality to ensure flawless conduct of clinical aspects of trials
- Ensures consistency across studies
- Reviews medical literature and related new technologies
- May support integrated document development for marketing authorization filing
- May support preparation for the FDA Oncology Drug Advisory Committee and EU Oral Explanation
What is Required
- Advanced medical degree preferred (not required)
- Minimum of 10 years oncology clinical development experience
- Significant experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports
- In depth knowledge of regulatory guidelines and ICH/GCP
- Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
- Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams
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.