Director, Regulatory CMC
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1939937
Job Description Summary
The Director of Regulatory Chemistry, Manufacturing and Controls (CMC) will report directly to the Vice President of Regulatory CMC. The individual will be responsible for working with the CMC teams to guide the CMC global regulatory strategy of Mirati's small molecule programs leading to successful preparation and approval of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), New Drug Application (NDA), and Marketing Authorization Application (MAA) submissions. The ideal candidate will have a strong CMC technical background, experience with preparing CMC regulatory submissions, and responding to Health Authority questions. In addition, excellent verbal and written communications skills are required.
- Responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions (e.g. IND, IMPD, NDA, and MAA) for submission to global Health Authorities in compliance with departmental and regulatory standards
- Develop and execute global CMC regulatory strategies in partnership with analytical, chemical, and product development for small molecule oncology compounds
- Prepare Health Authority responses & background packages (including participating/leading Health Authority meetings); and/or post-approval submissions.
- Independently manage and prioritize multiple complex projects
- Assess Manufacturing Change Controls for global impact and guide technical teams on global change management
- Participate as the Regulatory CMC Lead on CMC Teams
- Research and provide analysis of current US and international regulations and guidance
- Actively participate on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements
- Review and guide content of CMC information in nonclinical and clinical documents including clinical protocols and investigator brochures
- Communicates critical issues to Management
What is Required
- A minimum of a Bachelor of Science in chemistry or pharmaceutical science with a minimum of 12 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent is required
- A minimum of 5 years CMC Regulatory Strategy experience
- An MS, Ph.D., or Pharm. D. degree preferred
- Knowledge of EU and FDA regulations
- Experience directly writing submission documents that support clinical trials. Experience writing marketing applications is highly desirable
- Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy
- Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently
- Prepare and manage filings and ensure thoroughness, accuracy, and timeliness.
- Strong attention to detail with high-level verbal and written communication skills
- Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
- Excellent problem-solving skills
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 KRAS G12C 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 KRAS G12D 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.