Employment Type: Full Time
Reference Number: 1979682
Job Description Summary
Mirati Therapeutics is seeking an experienced and highly motivated Director of DMPK to support our fast paced and passionate drug discovery group. The successful candidate will take a lead role in setting DMPK strategies for small molecule discovery programs, planning and executing drug metabolism, pharmacokinetic and toxicokinetic studies using internal and external resources, and provide human physiology-based PK (PBPK) and efficacious dose predictions for lead molecules. You will be an essential member of discovery project teams, proactively identifying DMPK risks and suggesting solutions for the team. Working in collaboration with the clinical pharmacology group, the Director of DMPK will support clinical programs as requested and integrate in vitro DDI results and human dose predictions into first-in-human strategies. You form strong working interactions with project scientists across discovery including pharmacologists, toxicologists, bio-analysist, drug metabolisms scientists, and medicinal chemists. In addition, you are comfortable communicating and presenting your work to members of multi-disciplinary project teams and can teach your coworkers the underlying details of DMPK to help guide them in their decision-making process.
- Responsible for all aspects of DMPK for drug discovery projects from preclinical research into IND-enabling studies, assisting early clinical development as requested
- Perform modelling and simulations of human PK and efficacious dose to enable lead selection, evaluation of DDI risk and selection of first in human dose
- Perform PK/PD modelling to support advancement of leads
- Function as core team DMPK lead on multiple programs
- Design and manage internal and external DMPK studies in support of projects
- Identify key DMPK issues and design in vitro and in vivo ADME experiments to address these
- Design in vivo PK and toxicity studies, interpret PK, TK and ADME data and communicate results to project teams
- Provide IND packages and interact with regulatory agencies regarding preclinical data
- Support physical chemical profiling and dose form selection for PK and toxicity studies
- Supervise and provide mentorship to DMPK scientists
- Effectively collaborate and interface other functional areas such as medicinal chemistry, pharmacology, toxicology, and clinical pharmacology
- Provide excellent communication, interpersonal and leadership skills, and detail-oriented support to a fast-paced team environment
What is Required
- BS/MS/PhD in pharmacology/pharmaceutical sciences/analytical chemistry with 24/21/10 or more years of drug development experience in pharmaceutical/biotech companies
- Experience in GastroPlus PBPK modelling and Phoenix WinNonlin analysis of PK/PD data and the prediction of human PK and efficacious dose for lead compounds is required
- Proven record of experience as a DMPK representative on small molecule drug discovery teams
- Ability to manage several programs simultaneous and quickly adapt to change
- Experience in designing and conducting non-GLP and GLP studies for lead candidate selection and IND filing
- Expertise in ADME studies, interpretation of PK and TK
- Strong analytical chemistry skills and proficiency in MS-based analysis
- Hands-on experience with DMPK/ADME experiments and willingness to execute those experiments when necessary
- Ability to author IND reports with excellent written communication skills
- Excellent time management, verbal communication, and collaborative skills
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.