Senior Director, Global Safety Officer (GSO)
Department: Clinical Development
Employment Type: Full Time
Reference Number: 1593015
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 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, Pharmacovigilance (PV) and supporting signal detection and risk management activities. This individual will manage and 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.
- Establishing the strategy, direction, and priorities of pharmacovigilance 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 pharmacovigilance requirements.
- Represent PV and Safety Risk Management Department, as applicable
- Management and mentoring of the Safety Scientist(s) and Medical Reviewer(s) supporting the assigned product(s)
- Under the direction/review of Head of PV, participate in other PV and 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
- Hire, manage and 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
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.