SVP Innovative Medicines
Employment Type: Full Time
Reference Number: 1904364
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.
Reporting to the CMO, the Senior Vice President, Innovative Medicines Development will provide medical leadership and oversight for all of the Mirati oncology clinical programs as described in the following responsibilities:
- Leadership of the Clinical Leads, Medical Directors, Development Team Leaders and Clinical Development Scientists
- Provide strategic leadership and design input for all clinical programs
- Responsible for the delivery of a clinical strategy for the pipeline
- Oversee development of core study and regulatory documents including clinical development plans, protocols, investigator brochures, clinical study reports and regulatory submissions
- Lead the Protocol Review Committee
- Oversee the review, analysis, and reporting of clinical data in collaboration with biometrics to enable internal decision making and regulatory filings
- Drive excellence and key performance indicators in protocol development efficiency by leading and partnering with a cross-functional team, including Research, Biometrics, Clinical Operations, and Regulatory
- Partner with the Research and Development functions to ensure alignment of diagnostics strategy including patient selection and development of companion diagnostics
- Collaborate with leadership of Safety/PV organization in reviewing, analyzing and reporting of safety data from clinical trials
- Ensures clinical document and clinical plan compliance, complies with federal regulations, GCP and good medical practice
- Oversee preparation and execution for clinical presentations at scientific conferences
- Collaborate with clinical operations on investigator selection and engagement
What is Required:
- M.D. with board certification in Hematology/Oncology
- 15+ years clinical development and drug development experience in the biotechnology industry, pharmaceutical industry or academia
- Minimum of 5 years direct management experience leading clinical development disciplines
- Executive leadership skills to educate and influence stakeholders and to add value to strategic business planning and decision-making
- Extensive experience leading the design, conduct, analysis, and reporting of oncology clinical studies
- Scientific knowledge at a molecular level
- Successful IND, NDA/BLA, and CHMP filing experience and extensive health authority interactions
- Thorough understanding of GCP, ICH and global regulatory requirements
- Proven ability to manage, motivate and inspire a diverse group of oncology clinical disciplines
- Proven ability to effectively work in a cross-functional/matrix environment
- Significant experience successfully leveraging external partnerships
- Detail-oriented with an ability to think strategically and operationally on a wide range of issues in a solutions-oriented manner
- Exceptional interpersonal, problem-solving and written and verbal communication skills
- Excellent organizational and project management skills
- Outstanding clinical and business judgment
- Accomplished record of leading cross-functional teams in a matrixed organization
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 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.