Senior Clinical Development Scientist
Department: Clinical Development
Employment Type: Full Time
Reference Number: 1688120
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based late-stage biotechnology company relentlessly focused on translating drug discovery and research into new treatments for patients by advancing and delivering novel therapeutics that target the genetic and immunologic drivers of cancer. Mirati is advancing a novel pipeline to treat large patient populations across multiple programs and tumor types, including two programs, adagrasib (MRTX849) and sitravatinib, in registration-enabling studies to treat non-small cell lung cancer (NSCLC).
Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule, potent and selective KRAS G12D inhibitor in preclinical development.
Sitravatinib is an investigational spectrum-selective inhibitor of receptor tyrosine kinases (RTK) designed to enhance immune responses through the inhibition of immunosuppressive signaling. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a Phase 3 trial of sitravatinib in combination with nivolumab in NSCLC.
The Company has initiated plans to prepare for the commercialization of adagrasib by establishing its commercial and medical affairs team. Mirati's ambition is to continue to recruit and a build a world-class, high-performing team with a shared passion and dedication for transforming the future of cancer treatment.
We are Mirati
Our mission is to discover, design, and deliver breakthrough therapies to transform the lives of cancer patients and their loved ones. We have built a culture fueled by accountability, urgency, collaboration and open-mindedness, and have established ourselves as an innovator within our industry. As we grow, we are looking to build diverse teams, with skilled individuals that are passionate about their work.
Why join us?
Our pipeline is one of the most robust and exciting in the industry and fuels our ambition to make great strides in the fight against cancer. By joining Mirati, you will become part of a leading biotech company with a team of talented professionals dedicated to bringing the latest innovations in cancer treatment to patients. With a focus on teamwork and a commitment to do everything we can to support healthcare professionals in their effort to care for patients, we are well positioned to raise expectations for what companies can do to advance cancer care. We are passionate and dedicated, nimble and fast and are committed to empowerment to enable speed and high-quality customer service. While we go about it, our commitment to do first what is right is unshakable and we promise to put patients first in all that we do.
- In collaboration with the Medical Director, leads development of study protocol and amendments
- Routinely reviews clinical study data, querying discrepant data points to ensure accurate data reporting and significant focus on data quality
- Supports medical monitoring and reporting, evaluates clinical trial adverse events, reviews clinical laboratory results
- 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 AE section of ICF templates, eCRFs and SAE report forms
- Ensures consistency across studies
- Collaborates with the clinical development team on analysis and interpretation of study results
- Supports development of clinical sections of regulatory documents, including investigator brochures, annual safety update 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
- 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
- Contributes to clinical study report content
- Assists with preparing responses to questions from Health Authorities and Ethics Committees
- Supports general Clinical/Medical Affairs activities involving product evaluation, labeling & surveillance
- 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
- Advanced degree in a scientific discipline, minimum of master's degree; PhD, MD, PharmD, DO preferred
- 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
Mirati's policy is to provide equal employment opportunities to all applicants and employees without regards 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 informations, 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.