Sr. Director, Commercial / Regulatory Counsel
Employment Type: Full Time
Reference Number: 2150255
Job Description Summary
The Sr. Director, Commercial/Regulatory Counsel will be responsible for leading, driving, and managing all aspects of Mirati's Commercial and Regulatory legal needs in preparation of Mirati's first commercial launch and follow-on products. This role will provide strategic direction and guidance to the commercial team, be the legal representative on the promotional review committee, and lead all negotiations for Mirati's commercial contracts. This position reports into the Chief Legal Officer.
Provide advice, guidance, and counsel to internal brand teams regarding advertising and promotional activities, product labeling, sales and marketing strategies, compliance rules and regulations, FDA and OIG guidance documents, and industry codes (e.g., PhRMA) as they relate to business activities and communications with healthcare professionals and/or patients or patient advocacy organizations.
Serve as a legal representative on cross-functional Promotional Review Committees to provide legal feedback and direction on advertising, promotional and educational materials submitted for review.
Provide legal advice and lead the negotiation and drafting of contracts for the Commercial team, as well as Market Access, drafting and negotiating pharmaceutical commercial contracts (including payor and distribution agreements).
Review and analyze pipeline products/clinical trial recruitment materials, training materials, press releases, grants/donations and sponsorships, and related research on FDA/OIG enforcement activities.
Provide analysis, guidance, and support to the Medical Affairs department members, including Medical Directors, Medical Information, and Regional Medical Directors.
Provide analysis, guidance, and support on patient advocacy matters.
Assist with internal investigations related to violations of internal policies, as necessary.
Review and provide legal guidance on financial and other interactions with healthcare professionals, patients, or others in a position to influence healthcare decisions (e.g., payers, advocacy groups, distributors, etc.) to ensure compliance with applicable laws and regulations.
What is Required
- JD and an active license to practice law are required.
- At least ten years practicing law, with at least seven years of relevant experience in the biotech/pharma or healthcare industry. In-house experience is strongly preferred. Additional experience at a regulatory agency or major law firm is welcome.
- Significant experience supporting branded pharmaceutical products as cross-functional legal lead, including participation in promotional and medical review processes.
- Strong knowledge of the legal/compliance framework affecting the pharmaceutical/biotechnology industry, including sales and marketing, fraud and abuse issues, OIG and other industry guidance documents, and issues arising under the Anti-Kickback Statute and the False Claims Act.
- Ability to work with a high degree of autonomy and collaborate cross-functionally in a constantly changing, fast-paced environment with multiple competing deadlines.
- Accountability, sound judgment, and the ability to take ownership of an issue and recognize the business impact of legal advice.
- Ability to think creatively, devise practical solutions to challenging problems, and effectively drive legal and business issues to closure
- 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.
- 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.