V.P. Chief Compliance Officer
Employment Type: Full Time
Reference Number: 2131143
Job Description Summary
This position description intends to describe the general nature and level of work being performed by people assigned to this job. It is not intended to include all duties & responsibilities. The order in which the duties & responsibilities are listed is not significant.
Position Summary: The Chief Compliance Officer will be responsible for leading, driving, and managing all aspects of Mirati's global compliance program in preparation of Mirati's first commercial launch. The Chief Compliance Officer will provide strategic direction, compliance guidance to management, as well as implement and maintain all aspects of Mirati's compliance program. Specific responsibilities include policy and process implementation, leading effective training programs, conducting internal monitoring, directing investigations and corrective actions as needed, and chairing/participating on various risk management committees to help ensure organizational compliance with applicable laws, regulations, industry guidance and Mirati policies This person will work closely and cross-functionally with executive peers and functional units throughout our organization to lead and support compliance initiatives, and to raise the level of awareness of compliance within our organization. This position reports into the Chief Legal Officer.
- Design, build, implement and maintain a robust and effective U.S. and global compliance program that is right-sized for Mirati as it newly transitions to a commercial organization
- Develop strategies for and oversee day-to-day operations of Mirati's compliance program
- Analyze and interpret applicable laws, regulations, and related compliance landscape and provide practical, timely solutions to meet business needs;
- Employ monitoring metrics and provide regular reporting on Mirati's state of compliance to senior leadership, and Board of Directors;
- Champion a corporate culture in which employees recognize compliance as aligned with Mirati's core values, and regard it as a key factor in business decisions;
- Implement and execute monitoring plans, including ride-alongs for customer-facing remote employees;
- Chair Mirati's Compliance Committee and provide ongoing risk management input on business strategies and operations;
- Develop and participate in various risk management processes including review of promotional, medical and corporate materials, grant review, and federal and state transparency reporting;
- Facilitate investigations regarding matters of observed, reported or suspected non-compliance;
- Collaborate with functional heads as needed toward implementing recommended corrective actions;
- Keep abreast of FDA rules and regulations governing the advertising and promotion of pharmaceuticals; maintain current knowledge of enforcement actions and policy, code, guidance and other communications and expectations for pharmaceutical industry healthcare compliance programs in the U.S. and globally, as required
- Recruit, lead and manage one or more compliance professionals
- Manage and coordinate with vendors, third parties and others to support the development, implementation, and maintenance of the compliance program (e.g., reporting hotline; federal and state HCP/HCO reporting and requisite systems modifications for spend tracking; support learning management system implementation and oversight; Fair Market Value analyses for HCPs and Market Access; debarment screening; state law drug price transparency. Effectively manage associated budgets for these projects
What is Required
- JD (from an ABA-accredited law school), a healthcare compliance certification preferred, and a minimum of fifteen (15) years of relevant experience in the pharmaceutical/biotech industry, including roles in leadership
- A successful track record helping to build a culture of compliance and ethics in which compliance and business objectives are mutually reinforcing and establishing effective reporting, monitoring, and auditing programs
- Litigation or Government Investigation experience is preferred.
- Strong problem-solving skills - demonstrates and exercises creativity and initiative.
- Ability to gain trust at, and work with, all levels of organization.
- High level of integrity with the ability to maintain the protection of proprietary and confidential information
- Strong written and verbal communications skills - able to effectively collaborate and communicate with client groups, senior management and executives within the company.
- Ability to handle multiple projects simultaneously independently.
- Skilled at effectively consolidating and communicating information from diverse sources through all levels of the organization, up to executive management across all functional areas.
- Privacy experience preferred
- Ability to periodically travel
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.