Vice President, Medical Director
Department: Clinical Development
Employment Type: Full Time
Reference Number: 2131302
Job Description Summary
- Reporting to the President, Founder and Head of Research and Development, the Vice President, Medical Director will provide medical leadership and oversight for one or more Mirati oncology clinical programs as described in the following responsibilities:
- Leadership of Medical Directors and Clinical Development Scientists
- Provide strategic leadership and design input for all clinical programs
- Responsible for the delivery of a clinical strategy for the clinical program(s)
- Clinical leadership of global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the clinical development plan, GCPs, ICH and FDA and other regulatory authority requirements.
- Help identify global study sites and foster relationships with study investigators
- Chair internal and external clinical trial meetings-updating clinical staff and upper management on patient recruitment, trial issues, investigator's feedback, patient enrollment issues and presenting a plan of action for resolution of issues
- Oversee development of core study and regulatory documents including clinical development plans, protocols, investigator brochures, clinical study reports and regulatory submission
- 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
- 10+ years clinical development and drug development experience in the biotechnology industry, pharmaceutical industry or academia
- Minimum of 5 years direct management experience leading a team of Medical Directors at various levels
- 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
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.