Clinical Supply Chain Manager
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1750363
Job Description Summary
This position is responsible for the development and maintenance of investigational material supply plans and strategies for early and late stage small and large molecule development compounds throughout the life of a clinical study. As the clinical supply chain's primary input to cross functional teams (CMC team, project team, study team, etc.), the role liaises with the cross functions to proactively assemble key program/protocol attributes necessary to generate approvable clinical supply strategies and plans. With an advanced understanding of clinical protocol design and the risks associated with clinical supply chain activities, the CSPM is a key driver of the decisions that impact a clinical study's supply strategy by being a vocal member on teams while representing the clinical supply chain. The role will also work closely with vendors and internal support resources to ensure the on-time execution of activities in order to meet supply milestones.
- Responsible for review of clinical protocols and the development of supply chain strategies that ensure alignment with the clinical study plan, milestones, and the clinical development plan.
- Through a knowledge of clinical study design, the CSPM contributes to and influences protocol content and supply strategy to minimize drug supply and patient compliance risks.
- Engages cross functional peers to drive key decisions required to develop supply strategies and study objectives.
- Directs the planning and execution of clinical supply packaging, labeling, and logistics events with vendors to ensure timely delivery to support clinical studies.
- Working with vendors and internal resources, develops the strategy for comparators, labels, packaging, distribution and returns strategies.
- Provides input to the development of investigational product related content in study documents including investigator meeting documents, protocols, and pharmacy manuals
- Responsible to raise and communicate supply chain risks that may impact initial and on-going supply continuity, while presenting risk mitigation strategies to enable continuity.
- Contributes to the development of IRT system user requirements (URS) and user acceptance testing while ensuring the system manages drug supply effectively.
- Responsible for monitoring/facilitating drug supply events within IRT from study start-up through study closure
- Develops demand/supply forecast and communicates plans to key stakeholders (CMC, Manufacturing, etc.).
- Responsible to develop clinical supply budget and monitoring expenditures against the supply budget.
What is Required:
- BS/BA degree in related discipline and five to eight plus years of clinical supply project management experience preferred.
- Professional Project Management certification is also desirable
- Proficient knowledge of protocol interpretation, IRT URS development and UAT.
- Understanding of clinical supply interdependencies within the drug development process and clinical study execution.
- Demonstrated experience developing working with clinical supply vendors.
- Knowledge of temperature-controlled distribution, import/export and logistics
- Broad knowledge of and experience with cGMP, GDP and GCP standards and guidance documents such as Annex 13.
- Broad knowledge of CMC, manufacturing, Quality Assurance, Clinical operational processes
- Demonstrated experience in global clinical supply forecasting and planning, packaging and labeling operations, IRT and clinical trial design
- Proficiency with standard Microsoft applications (MS Word, MS Excel, MS PowerPoint, MS Project, MS Visio).
- Demonstrated ability in communicating, influencing and driving decisions while a member of cross functional teams supporting clinical studies.
- Ability to effectively work in complex, dynamic and fast paced drug development environment.
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.