Job Opportunity

Senior Director, Global Safety Officer

Location: US
Department: Clinical Development
Employment Type: Full Time
Reference Number: 2168420

Job Description Summary

Mirati is looking for a Senior Director, Global Safety Officer (GSO) to join our growing team. This position is responsible for establishing the strategy, direction, and priorities of pharmacovigilance (PV) activities and is accountable for the overall safety profile and all product-related decisions and deliverables for the assigned product(s). The GSO will lead and manage safety collaborations with development partners. The GSO will partner with internal stakeholders on establishing NDA safety strategies. This individual will also support other investigational and marketed products. This includes all pre- and post-marketing safety, PV and supporting signal detection and risk management activities. This individual will mentor the Safety Scientist(s) and Medical Reviewer(s) supporting the assigned product(s). The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

Your Responsibilities

  • Establishing the strategy, direction, and priorities of PV activities and is accountable for the overall safety profile and all product-related decisions and deliverables for the assigned product(s)
  • Identification, analysis and reporting of possible safety trends and concerns with assigned Mirati product(s), including the identification and evaluation of safety signals through the assessment of individual case safety reports and aggregate data summaries from clinical studies and post marketing experience, review of relevant literature articles, product quality complaints and non-clinical safety data
  • Research and carry out signal detection activities utilizing internal and external sources of investigational or marketed product safety data
  • Perform safety analyses and present these at cross-functional Safety Review Committee meetings and to Senior Management and prepare presentations for Board of Director Meetings
  • Lead the development, implementation and coordination of risk mitigation strategies (e.g. Risk Management Plans, REMS, Post-Marketing Evaluation Programs), to ensure the safe and appropriate use of Mirati products, in compliance with global legal and regulatory requirements
  • Lead the production of all relevant regulatory documentation (e.g. IND Annual Reports, DSUR, PSUR) as well as support the production of clinical documentation (e.g. Protocols, IBs, ICFs)
  • Lead collaboration with business partners around safety data evaluation and safety data exchange, including the creation of safety data exchange agreements and safety management plans, review of safety materials received from our partners
  • Lead PV responses to medical inquiries regarding safety issues, ad hoc requests from regulatory agencies, ad hoc requests to support CTAs with study sites, etc., as needed
  • Partnering with internal stakeholders on establishing safety strategies for NDAs, commercialization and post-market PV requirements.
  • Represent Safety Risk Management, as applicable
  • Management and mentoring of the Safety Scientist(s) and Medical Reviewer(s) supporting the assigned product(s)
  • Under the direction/review of Executive Director, Safety Risk Management activities as necessary

What is Required

  • Minimum of a PharmD, MD, DO, or NP with at least 10 years of experience in international PV with relevant clinical experience considered
  • Mentor safety scientist(s) and medical reviewer(s) responsible for assigned product(s)
  • Must have led PV strategy and activities for a compound including the preparation of DSURs, PSURs, Company Core Safety Information (CCSI) and Risk Management Plans
  • Experience with the identification and evaluation of safety signals through the assessment of individual case safety reports and aggregate data summaries from clinical studies and post marketing experience
  • Clinical development and post marketing experience required including establishment of strategies, priorities for PV activities
  • Thorough knowledge of current US, Global, and ICH safety management and reporting regulations and guidelines
  • Worked with a drug safety database (ARGUS experience helpful) and have had responsibility for medical review of SAE reports
  • Strong working knowledge of MedDRA and WHODrug coding dictionaries
  • Excellent written and oral communication skills in the English language
  • Ability to perform and present Safety Analyses to Senior Management and prepare presentations for Board of Director meetings
  • Resourcefulness and personal organization skills together with demonstrated cross-functional teamwork
  • Competent in Microsoft Word, PowerPoint, Excel
  • Ability to maintain an "inspection ready" environment
  • Strong attention to detail
  • Solid medical knowledge of methods to assess causality relationship between adverse events and investigational and marketed products
  • Relevant experience in the oncology therapeutic area, strongly preferred

About Mirati Therapeutics, Inc.

Mirati Therapeutics, Inc. is a clinical-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, MRTX1719, an investigational PRMT5 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 Inc., visit us at Mirati.com or follow us on Twitter and LinkedIn. 

Why Join?

Mirati has been named a Top Workplace by the San Diego Union-Tribune. Our passionate team are deeply motivated to participate in work that is both important and unique.

Our belief is that transforming the lives of those with cancer is more than a job -- it's the chance to be part of something game-changing.

Urgency, open-mindedness, accountability and collaboration ground our work and behavior. These shared values are central to who we are, what we do and how we do it.

Our culture is one where we challenge norms, have high-risk tolerance, and celebrate an entrepreneurial and courageous attitude full of grit and determination to make a difference. We strive to create a sense of belonging and inclusion - one in which we laugh and have fun as we drive change together.

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.

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.