Job Opportunity

Director, Medical Research and Data Operations

Location: US
Department: Medical Affairs
Employment Type: Full Time
Reference Number: 2376798

Job Description Summary

The Director, Medical Research & Data Operations is a versatile, and experienced medical affairs professional with a strong background in clinical and data operations. The ideal candidate will be an excellent communicator and team player with experience providing end-to-end management across studies and working within a highly matrixed organization. The role will be responsible for the oversight and coordination of protocols (startup, maintenance, and closure) with external strategic partners/institutions. Areas of focus of the role may include, but not limited to, operational oversight for medical affairs led investigator sponsored research, expanded access/compassionate use programs (EAP/CUP) and other study types of non-registrational data generation. This role may also partner with the internal cross-functional team to enable development and approval of medical content/ publications related to the medical data efforts.

Your Responsibilities

  • Oversee operations and maintenance for investigator sponsored research, expanded access/ compassionate use and other non-registrational data generation studies
  • Manage study activities including contracting, fair market value, drug supply and forecasting, safety reporting, activation activities, study conduct, the tracking and invoicing of project milestones, and study closure
  • Coordinate cross functional proposal and protocol review including summaries/minutes and actions for governance meetings
  • Direct/align related operational activities with finance, supply chain, clinical development, pharmacovigilance/safety, etc.
  • Ensure adherence to all related Mirati and regulatory authority compliance policies/guidance.
  • Direct activities related to review and tracking of data outputs and communications (eg, publications)
  • Identify and escalate issues and harmonize mitigation/ resolution strategies across stakeholders and/or functional management/ leadership
  • Collaborate with Medical Affairs including Medical Strategy and Regional Medical (field team) colleagues
  • Support additional medical activities within the Med Affairs team on an as needed basis
  • Travel may be required up to 20% of your time

What is Required

  • Degree in life sciences or related field
  • Minimum of 8+ years of industry experience with a minimum of 5+ years in oncology research
  • Solid analytical and problem-solving skills, strategic capabilities, project management and planning and organizational skills
  • Ability to communicate effectively, including scientific concepts, both in writing and in oral presentations
  • Ability to collaborate within matrix structured product team across multiple disciplines
  • Ability to effectively engage both internal and external stakeholders and collaboration partners
  • Strong track record of execution and operational effectiveness
  • Demonstrated ability to manage multiple projects and prioritize appropriately
  • Embraces an agile and flexible mindset as focus and role/responsibility may evolve over time

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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on Twitter and LinkedIn. 

Why Join?

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.