Vice President, Clinical Development, Adagrasib
Department: Clinical Development
Employment Type: Full Time
Reference Number: 1758855
Job Description Summary
The Vice President, Clinical Development for Adagrasib reports to the Chief Medical Officer. Working within approved corporate business strategies, you will develop and implement overall clinical development plans for Adagrasib and provide the medical expertise for building business strategies. This is a key role on the CMO Leadership team in regard to strategic planning and interacting closely with cross functional partners. The position will involve extensive interaction with internal senior management, outside experts, corporate partners, the FDA and key oncology thought leaders and experts in the fields of non-small cell lung cancer.
- Participate in an integrative and cross functional effort to identify high impact evidence generation opportunities and then originate, conceptualize and design registration and non-registration clinical trials, studies and exploratory analyses that have differential impact in the oncology space.
- Collaborate and drive the Adagrasib development program and related processes within the department;
- Work closely with internal teams to contribute, develop, implement, and deliver the designated product development and lifecycle plans, which includes the origination, conceptualization and design of registrational and non-registration clinical trials and studies
- Develop and maintain key opinion leader relationships
- Lead the scientific review processes to ensure accurate, appropriate, efficient and compliant review, execution and dissemination of Adagrasib projects intended for external audiences.
- Participate in advisory boards and strategic scientific collaborations with external constituents (e.g. thought leaders, cancer centers, and other affiliated or adjacent entities);
- Ensure that all strategic clinical development activities are managed effectively in support of regulatory submissions and subsequent approval.
- Possess clinical leadership and expertise in the development of study protocols and clinical study reports, study medical monitoring, safety reporting, regulatory documentation and interactions.
- Participate in cross-functional collaboration efforts to align and fulfill publication, communication, education and training objectives and plans;
- Understand and apply the current status of industry standards and practice and ensure activities are in compliance with GPP, ensuring both internal and external interactions comply with these standards;
- Conduct business in accordance with Mirati corporate values.
What is Required
- M.D/PhD/PharmD Degree with board certification/eligibility in Oncology
- Minimum of 7-10 years of Director level or above clinical development experience in the biopharmaceutical industry with demonstration of successful results;
- Experience bringing products through the FDA and EMEA regulatory process in the oncology space.
- Experience in drug development with in depth understanding of clinical trial design, clinical trial execution, regulatory requirements in oncology, and data analysis;
- 7 years'+ experience managing, leading, influencing and developing clinical development and medical affairs professionals in a changing competitive and technological environment;
- Ability to master the emerging and evolving clinical evidence in oncology and and be able to effectively communicate complex material to a wide variety of audiences including investigators, thought leaders, nurses and research coordinators;
- Expert knowledge of guidelines under which biopharmceutical companies operate (FDA, PhRMA, OIG, etc);
- Proven ability to act as a medical spokesperson for external audiences;
- Demonstrated success in developing and managing strategic relationships with medical oncology experts and key thought leaders;
- Knowledge and application of business planning & leadership principles, such as data analysis, goal setting, action plans, monitoring tools, directive and supportive techniques to develop and implement action plans;
- Strong managerial, leadership, and influencing skills;
- Fluent in English and excellent written and oral communication skills; fluency in other languages highly desired.
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.