Senior Manager, Clinical and Regulatory Submission Review
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 1621522
Job Description Summary
The Senior Manager, Clinical and Regulatory Submission Review will report directly to the Senior Director, Quality Assurance. The individual will be responsible for performing quality control reviews of various clinical documents in support of Mirati's small molecule programs. The individual will also be responsible for reviewing applicable data in support 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 quality assurance / GXP compliance background, experience with small molecules, and regulatory inspections. In addition, excellent verbal and written communications skills are required.
These may include but are not limited to:
- Review of Clinical documentation such as clinical protocols, ICFs, CSRs, IB, Annual reports, and Pharmacy Manuals, etc.; and conducting audit of document against the source data, certifying compliance with study, regulatory and GXP requirements.
- Collaborate with Mirati Clinical colleagues to ensure timely reviews of clinical documentation to meet submission deadlines
- Participation in weekly clinical project team meetings representing Mirati QA
- Coordinate multiple QC reviews of clinical documentation supporting multiple programs
- Conduct QA checks of QC reviews and ensure all corrections are made
- Generation of audit summaries for each QC review
- Ensure GXP compliance is maintained
- Ensure clinical documentation meets regulatory requirements
- May perform document change control activities (i.e., SOP writing) as needed
- Develop, revise, implement and adhere to Quality Assurance department policies and procedures
- Assist with maintaining file organization within the Quality department
- Other duties as assigned
What is Required
- Bachelor's or Master's degree in Life Sciences field or equivalent years experience, with 8+ years pharmaceutical industry experience and a minimum of 6 years in Quality Assurance.
- Previous small molecule drug and NDA-level experience are a strong plus
- Established working knowledge of Good Clinical Practices and Good Manufacturing Practices and other applicable regulations (US and international).
- Quality Assurance experience supporting both development projects and commercial products.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
- Strong communication skills both written and oral.
- Ability to multi-task and shift priorities rapidly to meet tight deadlines.
- Professional demeanor and an excellent written and verbal communicator.
- Detail oriented and well organized.
- Good and thoughtful listener.
- Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
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.