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Director Clinical Supply Chain - Menlo, United States - DSJ Global
Description
(Onsite 2-3 times per week)What We Look For
We are looking for curious and committed individuals who are ready for the opportunity to transform the way people living with cancer can be treated.
We are in search of team members who work collaboratively with a diverse group of colleagues, respectfully engaging one another while collectively and inclusively tackling any challenges we may face.
We are building an exciting and fast paced company passionate about discovering and developing tomorrow's most innovative cancer therapies.We are seeking an
Associate Director of Supply Chain
to lead the supply chain for novel clinical programs.
The Associate Director of Supply Chain will be accountable for building the clinical supply and demand planning processes, managing clinical orders and providing oversight for logistics providers throughout the development stages of antibody-based radiopharmaceuticals.
This role will be the main liaison between Tech Ops, Clinical Operations, CROs, CMOs and clinical sites for ongoing and new clinical studies.
Principal ResponsibilitiesLead and manage clinical demand and supply plans
Lead and manage clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory managementPartner with Clinical Operations for evaluation and selection of CRO partners and IRT vendors.
Collaborate regarding CRO capabilities to support study execution of study supply, including global depot networks and IRT functionality, as necessaryEstablish and maintain clinical demand plan by chairing a monthly rolling forecast process.
Aligning supply plans and orders with the rolling forecastServe as the clinical supply lead for assigned program(s) and develop/manage the clinical supply planCollaborate with cross-functional teams (i.e.
Clinical Operations, QA, CMC, and Regulatory) to proactively identify and mitigate potential risks to the continued advancement of the clinical programsManage clinical orders, inventory of drug substance and starting materials
Single point of contact for manufacturing sitesOversee and coordinate clinical order management process to ensure clinical sites received the drugs on time per planServe as internal lead for triaging of product issues, temperature excursions, and deviations originating from and clinical sites.
Accountable for vendor management process and logistics process
Lead vendor identification, selection, onboarding, and management for combo agent/comparator sourcing and secondary packaging and distributionManage contract, budget and performance of logistic providers.
Business Process
Establish supply chain business processes as neededCreate SOPs and work instructions to govern cGMP activitiesSupport budgetary requests for supply chain and logistic costs
Qualifications, Education & Experience
B.S. or M.S. in scientific fields with 8+ years of experience in clinical supply chain and logistics in the biotechnology environmentDemonstrated in-depth experience of establishing, refining, and operating clinical supply chain in the biotechnology industryAPICS certification preferredExpertise in Lean is desirableWorking knowledge of import and export laws and processesExperience working effectively with CMOs and CROs
Skills & Abilities
A solid understanding of GMPs and CMC requirements is expectedDemonstrated thought leadership in clinical supply chainExperience in preparing regulatory filingsCapable of working on multiple projects/tasks and able to meet timelinesTeam-oriented, progressive thinker who enjoys participating in an innovative and creative work environment Excellent verbal and written communication skills.
Ability to operate in a fast-paced, multi-disciplinary industrial environmentA solid understanding of GMPs and CMC requirements is expectedDemonstrated thought leadership in clinical supply chainExperience in preparing regulatory filingsCapable of working on multiple projects/tasks and able to meet timelinesTeam-oriented, progressive thinker who enjoys participating in an innovative and creative work environment Excellent verbal and written communication skills.
Ability to operate in a fast-paced, multi-disciplinary industrial environmentAbility to critically evaluate and troubleshoot complex problems and attention to detail#J-18808-Ljbffr
