Job Opportunity

Associate Director, Drug Safety Physician

Location: San Diego, CA, US
Department: Clinical Development
Employment Type: Full Time
Reference Number: 2056940

Job Description Summary

Mirati is looking for a Drug Safety Physician to join our growing team within the Pharmacovigilance & Safety Risk Management group (PV & SRM) group, whose priority is ensuring the safety of our medicines and patients worldwide.

Physicians who work in PV & SRM are responsible for ensuring the safety of our medicines, which focuses on single case and aggregate data safety monitoring for signal detection and evaluation, contributing to benefit-risk assessments, and risk management planning, for assigned investigational and/or marketed products throughout the products' lifecycle(s).

As an Associate Director, Drug Safety Physician, you will be part of a highly skilled and international cross-functional team working to develop Mirati's growing portfolio of innovative medicines in oncology. This role will provide opportunities for significant professional development, reporting to the Global Safety Officer. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. The ideal candidate is passionate about learning and oncology drug development, and has strong verbal and written communication skills.

Your Key Responsibilities

  • Prioritize the safety of assigned product(s) and patients.
  • Provide medical safety expertise and risk management for assigned product(s).
  • Active participation in the assigned product cross-functional Safety Management Team(s), whose mandate is to provide integrated assessments of safety data for a development project or marketed product with significant clinical activities.
  • Perform on-going medical review of emerging safety data from various sources, including but not limited to individual serious adverse event case series, tabulated aggregate data, and published literature, to identify and evaluate safety signals.
  • Analyze validated signals, author Safety Assessment Reports, and recommend appropriate risk communication and mitigation.
  • Assist in the development and draft responses of safety-related responses to queries from regulatory agencies.
  • Participate in the analysis of safety data from on-going and completed clinical trials, and review safety sections of Clinical Study Reports.
  • Effectively contribute to the preparation and review of periodic safety reports (DSUR, PSUR/ PBRER) and relevant safety sections of the Investigator's Brochure.
  • Contribute to the development of risk management documents (e.g., Risk Management Plan) for submission to regulatory agencies.
  • Maintain compliance with pharmacovigilance regulations of regulatory agencies around the globe through effective and timely completion of medical safety activities and training.
  • Participate in inspection readiness activities and preparation as needed.
  • Provide a contributory role in partner / collaboration agreements and interactions, as required.
  • Participate in the departmental development activities including Standard Operating Procedures (SOPs) and Work Practice Instructions.

What is Required

  • MD degree or equivalent (e.g., DO or MB) required.
  • Experience in oncology not required, although given the medical complexities of oncology patients, the candidate must demonstrate the ability to research and synthesize relevant information efficiently.
  • At least 2 years of medical practice experience and broad knowledge of medicine.
  • Experience in a prior drug safety physician role in biotech or pharmaceutical industry is not required, although the ability to adapt to a new role and a matrix environment is a key transferrable skill.
  • Attention to detail and ability to analyze data in broader context, ability to (re)prioritize work/tasks of oneself and others
  • Excellent written and oral communication skills are key requirements; the ideal candidate will have a keen interest in analyzing data and concisely summarizing inferences and conclusion.
  • Strong influencing skills and the ability to explain and defend positions regarding significant issues to cross-functional peers.
  • Competent in Microsoft Word, PowerPoint, Excel
  • Ability to work independently and strong attention to detail

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.