Director, Clinical Supply Chain CA based
Department: Technical Operations / Supply Chain
Employment Type: Full Time
Reference Number: 2049765
Job Description Summary
The Director of Clinical Supply Chain will report to the Head of Clinical Supply Chain at Mirati and manage a team of Clinical Supply Managers with responsibility for the leadership and oversight of global clinical trial supply for all Mirati's clinical development programs. The scope of this role includes the management of the clinical supply chain team and related activities with a hands on, roll up the sleave attitude. We are looking for a candidate to lead and manage the tactical priorities across the clinical portfolio whilst also being able to identify and drive opportunities for ongoing improvement. The role will lead and manage the function through a purpose-built clinical supply chain, which through its organizational structure, tools, and processes is an influential and value-added member of the development organization and clinical programs. The ideal candidate thrives in building effective and efficient cross-functional processes through team collaboration and with exceptional communication and interpersonal skills, while leveraging internal and vendor-based resources.
- Lead clinical supply chain team to support proactive planning and execution for the timely release of clinical supply.
- Responsible for establishing and executing clinical supply strategy for clinical studies
- Leads a team of clinical supply chain professionals whose drug development and clinical supply expertise are inputs to cross functional teams, including clinical supply project managers, packaging, labeling, distribution, comparator sourcing and IRT management
- Drives and influences the identification, development and implementation of business process, tools, systems and Standard Operating Procedures (SOP's) that ensure effective operations which support compliance and timely supply availability
- Engages functional peers and stakeholders to identify process gaps/constraints and establishing consensus and alignment on process improvement initiatives.
- Supports company development pipeline objectives by aligning CSC resources as needed and justifies resources required to meet those objectives.
- Maintains vendor oversight for the following supply chain areas:
- Clinical label text development
- Clinical packaging
- Clinical distribution
- Comparator sourcing
- Interactive Response Technologies (IRT)
- Responsible for clinical labeling processes in compliance with applicable regulations, including processes around blinding, randomization, packaging design
- Develop, maintain and publish relevant Key Performance Indicators (KPI's) and clinical study dashboards
- Financial oversight of the clinical packaging and labeling vendors.
- Key contributor in Study Execution Teams (SET), Clinical Strategy Team (CST), and related CMC and organizational meetings. Collaborate with Clinical Operations, Regulatory Affairs, Quality Assurance, Technical Operations/ CMC, Project Management to develop ideal supply strategies to support availability of product to patients
- Mentor and develop staff - foster environment of innovation and growth by providing clear vision, expectations and direction to the team
San Diego based preferred, but open to remote with some travel.
What is Required
- BS/BA degree is required (packaging engineering, supply chain, or similar); Masters is preferred. At least 12 years of related Industry experience is required
- Demonstrated experience leading people with direct reports
- Experience in cGMP packaging operations is required with knowledge of clinical trials operations is necessary.
- Candidates should have a strong understanding of US and EU regulations on labeling and packaging implementation.
- Keen attention to detail and accuracy is important.
- Excellent verbal and written communication skills in English is necessary.
- Strong analytical skills
Experience and Qualifications Preferred:
- Process improvement / continuous improvement mindset with demonstrated experience and or training
- Label development process experience
- Experience with various IRT platforms
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.