Executive Director, Data Management
Employment Type: Full Time
Reference Number: 2055261
Job Description Summary
Represents Biometrics as the subject matter expert in Clinical Data Management responsible for all activities carried out by the team members. You will ensure your team is in compliance with SOPs and processes, resourced and budget planning, vendor selection and provide oversight to the outsourced vendors, and proactively recommend process improvement to increase efficiency of the data management function as well as ensuring it is regulatory compliance.
Represents Biometrics as the subject matter expert in Clinical Data Management (CDM) by providing strategic planning and tactical directions for Clinical Data Management activities across all projects in all phases of development
Extensive experience in performing forecast and manage budget, timelines, and resource needs; ensures budgets, schedules, and performance requirements are met
Proven track record in providing strong leadership and inspiration to the Clinical Data Management team; recruits, develops, and retain high talents
Interacts internally and externally with executive management requiring negotiation of challenging matters to influence decision making
Experienced in establishing data management processes to ensure data quality/integrity and meet regulatory compliance; experienced with regulatory inspection is a plus
Identifies, solicits, and review bids from data management vendor(s) for project(s) and make recommendations to the Biometrics Management team
Provides oversight and guidelines to CROs to ensure timely delivery and regulatory compliance of outsourced activities; may oversee CROs data management function inspections and audits
Directs with executive oversight, Clinical Data Management activities including CRF/eCRF design, database development, validation programming, discrepancy management, and database releases
Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas
Sets visions for Clinical Data Management, operations, infrastructure, and technology
Promotes and lead standardization, automation, innovation, implement policies, standards and process improvement, and technology enhancement in Clinical Data Management and beyond to increase drug development efficiency
Ensures Data Management Plans (DMPs) are consistent and regulatory compliant across studies and programs to meet the growing needs of the company portfolio (DMP includes Case Report Form (CRF), CRF completion guidelines, SAS annotated CRFs, data handling plan, data entry review guidelines, data edit check specifications, data transfer specifications, database audit plan, database release plan)
Maintains current data management best practices and systems used in data collection
What is Required
BS/MS or equivalent; preferably in the scientific/healthcare discipline
At least 18 years of Clinical Data Management experience in the pharmaceutical/biotechnology industry
Prior experience in oncology therapeutics including hands-on global submission experience in NDA/MAA are required
Proven leadership and management skills to lead a large group and the ability to hire and develop team members
A proactive and independent thinker in problem solving; ability to anticipate data management related problems with the ability to recommend creative technical solutions to avoid potential issues
Experience in managing multiple CROs
Advanced knowledge of CDM processes, systems, and technology advancements
Full understanding of ICH, GCP and other global regulatory guidance related to data
Advanced working knowledge of data management principles, including knowledge of Data Standards (ie, CDISC)
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.