Associate Director, Toxicology
Employment Type: Full Time
Reference Number: 1916510
Job Description Summary
The Associate Director, Toxicology will be responsible for oversight of toxicology studies for all preclinical and clinical programs. A solid background is required in Toxicology including knowledge and understanding of Good Laboratory Practices (GLPs), ICH Guidelines and integrated safety strategies from early discovery through drug approval.
- Oversight of toxicology studies including but not limited to, single- and repeat-dose toxicity, genetic toxicology, safety pharmacology, and development and reproductive toxicology studies to support small-molecule drug development in oncology.
- Assist in the design and timely reporting of toxicology studies.
- Coordinate preclinical safety evaluations of development candidates with CROs and consultant(s) to ensure timely delivery of high-quality data and study reports.
- Work with external consultant(s) to address toxicology-related studies as needed.
- Monitor studies and review reports generated by CROs.
- Provide written toxicology summaries for regulatory documents such as CTD sections for INDs and NDAs, IBs, and briefing books to support clinical trials and drug registration.
- Address and resolve toxicological issues arising in drug discovery and development programs, and adequately assess the relevance of any toxicological findings to human safety.
What is Required
- PhD or DVM in Toxicology, Pharmacology, or a related science with 5+ years of industry experience in conducting small molecule drug safety assessment studies
- Solid understanding and working knowledge of regulatory toxicology, GLPs
- Strong verbal and written communication skills; ability to communicate clearly and effectively with scientific colleagues and executive management
- Performs independently and professionally when managing CROs
- Possesses effective time management, organizational and interpersonal skills, conflict management, problem-solving skills.
- High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
- Works effectively in a matrix cross-functional environment. Ability to establish and maintain culturally sensitive working relationships
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 KRAS G12C 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 KRAS G12D 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.