Job Opportunity

Director, Clinical Data Management

Location: San Diego, CA, US
Department: Biometrics
Employment Type: Full Time
Reference Number: 2376582

Job Description Summary

Represents Biometrics as the subject matter expert in Clinical Data Management on the assigned clinical program team(s). You will ensure your team is in compliance with SOPs and processes, provide oversight to the outsourced vendors and proactively recommend process improvement to increase efficiency of the data management function.

Your Responsibilities

  • Represents Biometrics as the subject matter expert in Clinical Data Management (CDM) on the clinical program teams
  • Coordinate with CRO to ensure completion of all aspects of data review; including running validation procedures, issuing queries, database QC, SAE reconciliation, medical coding, and database closure activities according to timelines
  • Oversee the development and quality control (QC) of data management documents including data management plans, data validation specifications, data transfer agreements, and database quality control to meet the growing needs of the portfolio
  • Ensure the design/program eCRFs, edit checks, and derivations in the EDC databases are according to plan; perform and document user acceptance testing on databases and oversee database migrations
  • Responsible for consistent CDM documentation within assigned development program; manages Mirati URL to include study set up activities including creation of user environments, access support and provisioning, optimization and update activities
  • Participate in Sponsor data review across Mirati clinical trials
  • Facilitate the development and implementation of key data and metrics reports/listings for each clinical trial in conjunction with study team
  • Recommend improvements to CRO Clinical Data Management practices and procedures including identifying and recommending solutions for technology issues
  • Proactively identify, analyze, propose creative solutions, and effectively resolve complex data issues by exercising appropriate judgement and collaborating with the clinical project team members
  • Develop departmental Mirati SOPs and Work Instructions; proactively propose and develop departmental standards to improve efficiencies
  • Foster and promote the long-term development of the CDM teams, work closely with other functional leads to improve cross-functional operational excellence
  • May identify, solicit, and review bids from data management vendor(s) for assigned project(s) and make recommendations to the Biometrics management team
  • Identify resource needs to support the assigned portfolio to minimize costs and maximize utilization/realization to ensure key goals are met on time
  • May hire, supervise, train, and provide mentorship in career development and performance management of individual employees

What is Required

  • BA/BS, preferably in the scientific/healthcare field
  • At least 10 years of experience in data management for the pharmaceutical/biotechnology industry
  • A proactive and independent thinker in problem solving; ability to anticipate data management related problems with the ability to recommend creative solutions to avoid the problems
  • Had leadership experience and the ability to hire and develop staff
  • Experience in managing first line managers and previous experience as mentor to junior data managers

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.