Director, Compliance (Remote or Office Based)
Employment Type: Full Time
Reference Number: 2578740
Job Description Summary
The Director, Compliance will assist with the development and implementation of a healthcare compliance program at Mirati, including being responsible for the implementation of systems, programs, processes, and practices to ensure that the Company is in compliance with legal and regulatory requirements and its policies. The Director, Compliance will provide a broad range of compliance support throughout Mirati's organization; partnering with the business to sustain Mirati's ethical and compliant culture and develop practical ways to uphold the legal, regulatory, and ethical obligations of a pharmaceutical company
- Independently drive the development, implementation, and management of the compliance program, including policy, process, training, communication, auditing, monitoring, and investigations
- Lead and manage all compliance operations activities including providing compliance oversight and participating, as required, in review and approval processes for core Commercial and Medical activities: grants, sponsorships, speaker bureau, advisory boards and other initiatives involving interactions with healthcare professionals, healthcare organizations and patients/advocacy groups.
- Develop and be responsible for oversight of the company's compliance auditing and monitoring program; including:
- Assessing organizational compliance risk in creating and updating a risk-based audit and monitoring plan. Partnering with the business to address detected noncompliance including recommending and taking corrective actions when needed
- Track and report results of compliance investigations and the corrective actions taken to Compliance leadership and other internal key stakeholders as needed. Interpret findings/trends and carry out corrective action and retraining as needed
- Develop and oversee a comprehensive compliance training program and communication strategy to U.S. employees and designated third parties on applicable compliance policies, laws and regulations, including any new developments or updates that may impact the Company's compliance program.
- Create and lead the transparency reporting program, including developing, reviewing, and submitting reports related to federal and state transparency ("Sunshine") laws.
- Monitor the business developments and industry compliance best practices to evolve the compliance program through ensuring appropriate practices, processes, systems and tools are in place and maintained to support the business at all times.
- Be an ambassador for communication around key compliance topics, resources, and special initiatives
What is Required
- Bachelor's degree and 10 years' experience or any combination of education and experience providing equivalent background.
- Certification in Healthcare Compliance (CHC) preferred
- Working knowledge and previous experience in a compliance operations or project management position desired
- Excellent interpersonal, communication and written skills, proven ability to work independently with a wide range of stakeholders.
- Strong presentation and training skills and ability to work independently.
- Interact with employees and manage vendors
- Up to 20% travel may be required.
- Role will be remote.
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.