Associate Director, Clinical Supply Chain

2 weeks ago

Foster City, United States Mirum Pharmaceuticals Inc Full time

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare diseases. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. Learn more about our work, our culture, and what it's like to be a part of our team: www.mirumpharma.com.

POSTION SUMMARY

Reporting to the Senior Director, Clinical Supply Chain, the Associate Director is responsible for the global supply and distribution of investigational drug product for Mirum's ongoing clinical trials inclusive of the oversight management of multiple Contract Manufacturing Organizations (CMOs) and distribution providers. The ideal candidate is a self-starter with the ability to work independently under minimal supervision.

JOB FUNCTIONS/RESPONSIBILITIES

* Leads and establishes the overall strategy for Clinical Supply for all Mirum investigational drug products.
* Creates and maintains Clinical Supply forecasting models ensuring investigational material production is on par with corporate and financial goals, study enrollment, and business continuity.
* Leads the Clinical Supply program for investigation drug product inventory management and distribution in partnership with CMOs; evaluates drug utilization versus forecast considering country requirements and logistical timelines.
* Responsible for the oversight of Clinical Supply CMOs inclusive of selection (RFI), contract negotiations, financial review, daily operations, and the routine assessment of CMO performance via formal Business Reviews.
* Responsible for the management of global resupply strategies in IRT systems.
* Responsible for the creation, periodic review, and maintenance of all Clinical Supply SOPs.
* Accountable for initiating, overseeing, and resolving departmental deviations.
* Serves as the primary representative/subject matter expert (SME) during all inspections and clinical supply chain audits. Interacts with the Clinical Operations, CMC, Quality, and other functions to ensure optimal execution of the Clinical Supply strategy for investigational drug products.
* Supports project-related interactions with IRT vendors and Contract Research Organizations.
* Supports the preparation and review of Mirum documentation including regulatory applications, clinical trial applications, routine amendments, protocols, briefing documents, Quality Technical Agreements, responses to health authority inquiries, and other documents as required.
* Management and oversight of Clinical Supply direct reports responsible for daily operations, distributions, and labeling activities (inclusive of consultants)

QUALIFICATIONS

Education/Experience:

* Degree in biological or life sciences, pharmacy or medicine (or international equivalent). An advanced degree is desirable. A minimum of 8 years in the pharmaceutical industry or relevant work experience and a minimum of 6 years in Clinical Supply Chain.
* Proficient in the daily management and operations of a Clinical Supply Chain inclusive of bulk management, distribution, and maintaining study blinds across multiple investigational products.
* Experienced with Clinical Supply Chain systems for inventory management and resupply (Interactive Response Technology - IRT).
* An experienced people manager both from a direct report and consultant relationship.
* Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
* Excellent communication skills both in writing and verbally.
* Experienced in assisting as the Clinical Supply Chain SME during Regulatory Inspections and Audits.

Knowledge, Skills and Abilities:

* Experienced with Clinical Supply Chain systems for inventory management and resupply (Interactive Response Technology - IRT).
* Knowledge of import / export requirements.
* Proactive in driving performance cross-functionally and fostering collaboration.
* Proficient /good knowledge of industry technology.
* Applies and drives Forecasting and Planning activity as it relates to protocol.
* Ability to build/drive internal team consensus.
* Translates broad strategies into specific objectives and action plans.
* Proficient in team and individual leadership.
* Knowledge and experience relating to clinical trials would be desirable.

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

  • Supply Chain Procurement Specialist

    2 weeks ago

    Johnson City, United States Corporate Supply Chain Full time

    Supply Chain Procurement Specialist (FT) Johnson City, TN Job ID: 004ECR BALLAD CORPORATE Corporate - Corporate Supply Chain Full-time (scheduled 72 hrs or more per pay period) - Day Job Description SCOPE OF POSITION The Procurement Specialist I is primarily responsible for the acquisition of medical supplies and services necessary to provide high quality...

  • Clinical Supply Chain Specialist

    2 weeks ago

    Foster City, CA, United States LanceSoft Full time

    TypeContract (Full Time)Title : Clinical Supply Chain Specialist Location : Foster City,, CASpecific Responsibilities & Skills for the Position: • Works on non-routine to routine problems where analysis of situations or data requires an evaluation of identifiable factors. • With guidance may exercise independent judgment in developing methods, techniques...

  • Supply Chain Associate

    2 weeks ago

    Iowa City, United States University of Iowa Full time

    The University of Iowa Hospitals and Clinics Supply Chain Department is seeking a Supply Chain Associate to manage supplies in the operating rooms and clinic areas. Duties to include: Serve as a Supply Chain Department liaison for clinics and operati Supply Chain, Associate, Supply, Microsoft, Hospital, Shift, Transportation, Education

  • Senior Director, Clinical Supply Chain

    2 weeks ago

    Redwood City, United States Revolution Medicines, Inc. Full time

    Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment...

  • Supply Chain Specialist

    7 days ago

    Foster City, United States Tranzeal Full time

    Role: Supply Chain Specialist II - SAP Location: Foster City, CA - Remote Description: As the SAP Business Network Supplier Enablement , you will be responsible for driving the successful onboarding and integration of suppliers onto our SAP Business Network platform. You will play a key role in maximizing the value of our SAP Business Network investment by...

  • Pharma Supply Chain Analyst

    1 month ago

    Foster City, California, United States QData Full time

    Required Qualification for this role Candidates must have at least 8+ years of experience in Pharma/Life Sciences Supply Chain and need to have experience executing and managing Pharma/Life Sciences Supply Chain projects and MUST understand the end to end Pharmaceutical Supply Chain Lifecyle Process which includes planning execution and SC collaboration...

  • Pharma Supply Chain Analyst

    1 month ago

    Foster City, United States QData Full time

    Required Qualification for this role Candidates must have at least 8+ years of experience in Pharma/Life Sciences Supply Chain and need to have experience executing and managing Pharma/Life Sciences Supply Chain projects and MUST understand the end to end Pharmaceutical Supply Chain Lifecyle Process which includes planning execution and SC collaboration...

  • Supply Chain Program Manager

    4 hours ago

    Foster City, United States Knewin Full time

    The Supply Chain, Quality & Reliability (SCQR) team is seeking an experienced Program Manager to support our supply chain management-related activities across the organization. In this role, you will own the Supplier Health & Readiness initiative at Zoox, functioning as the overall program manager as well as key liaison between strategic sourcing, supplier...

  • Supply Chain Specialist

    2 weeks ago

    Foster City, United States Intelliswift Software Inc Full time

    Client Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff...

  • Supply Chain Specialist

    4 days ago

    Foster City, United States Netpace Full time

    Job Description Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our...

  • Supply Chain Specialist

    4 days ago

    Oklahoma City, United States Akka-Technologies Full time

    Job Description:PDS Tech is seeking an Entry Level Supply Chain Specialist for our Oklahoma City, OK Warehouse Distribution facility. The Supply Chain Specialist will be an integral member of our clients Warehouse Management team. Provides and analyzes post production spare/repair data to manage program items throughout the supply chain process. Analyzes...

  • Supply Chain Specialist 1

    4 days ago

    Oklahoma City, Oklahoma, United States PDS Defense Full time

    EngineeringSupply Chain Specialist 1 - Job ID#205899 Oklahoma City, OK Posted: 5/13/2024Job DescriptionJob ID#:205899Job Category:EngineeringPosition Type:Associate - W2Duration:52Shift:1PDS Defense, Inc. is seeking a Supply Chain Specialist 1, in Oklahoma City, OK.Job Description:Seeking an Entry Level Supply Chain Specialist for our Oklahoma City, OK...

  • Supply Chain Manager

    3 weeks ago

    Oklahoma City, United States Citwell Consulting Full time

    Want to get involved in a French fast-growing structure where professionalism, entrepreneurship and enthusiasm meet? Good news: Citwell is looking for a Supply Chain Manager for its first international office in Boston. About you You have a master’s or MBA degree from a top notch college, university, in either business or engineering school. You have 6 to...

  • Supply Chain Analyst

    4 days ago

    Grove City, United States NSG Group Full time

    Primary Duties: Slow Moving/ Obsolete (SLOB) elimination: Finished products:Run reports to identify slow moving inventory of finished and semi-finished goods across all facilities and warehouses.Compare stock data with consumption to determine coverage.Work with NMI/Procurement to align part numbers and product characteristics.Work with AGR Sales team to...

  • Supply Chain Coordinator

    2 weeks ago

    Arizona City, United States DPS Group LLC Full time

    Summary Arcadis DPS Group is seeking a Supply Chain Coordinator to join our Global Supply Chain Management team based in Chandler, AZ. As the Supply Chain Specialist within DPS' Advanced Technology Group, you will be responsible for supporting process improvement programs related to high-tech industrial construction projects on a global scale. Successful...

  • Supply Chain Coordinator

    1 week ago

    Arizona City, United States DPS Group LLC Full time

    Summary Arcadis DPS Group is seeking a Supply Chain Coordinator to join our Global Supply Chain Management team based in Chandler, AZ. As the Supply Chain Specialist within DPS' Advanced Technology Group, you will be responsible for supporting process improvement programs related to high-tech industrial construction projects on a global scale. Successful...

  • Senior Supply Chain Manager

    5 days ago

    Kansas City, United States Advantage Tech Full time

    Advantage Tech is looking for a Senior Supply Chain Manager for our Ohio client.This role is responsible for the direction, strategy, planning and execution of Supply Chain activities (including governance and risk management) for BCP in line with the strategy established at the corporate level. This position manages and oversees the S&OP processes, sourcing...

  • Manager, Supply Chain

    4 days ago

    Elizabeth City, United States Sentara Healthcare Full time

    Assume responsibility and accountability for the operational success of a hospital Materials Management department. Responsible for the delivery of high quality services that meets or exceeds customer expectation. Achieve system, hospital and departm Supply Chain, Manager, Microsoft, Project Management, Supply, Manufacturing, Healthcare

  • Supply Chain Manager

    2 weeks ago

    Michigan City, United States Bluejay Solutions Full time

    Manager, Supply Chain Management Summary of Position: The Manager of Supply Chain Management leads a team responsible for the sourcing and delivery of all the materials and services necessary to support Company factory production and aftermarket operations. This group is responsible for local and international sourcing and procurement activities in support...

  • Supply Chain Manager

    2 days ago

    Michigan City, United States Bluejay Solutions Full time

    Manager, Supply Chain ManagementSummary of Position:The Manager of Supply Chain Management leads a team responsible for the sourcing and delivery of all the materials and services necessary to support Company factory production and aftermarket operations. This group is responsible for local and international sourcing and procurement activities in support of...