Senior Manager, Clinical Trial Supplies

🕒 Maio 8

🏄 California – Remoto

🏄 California – Remote

💵 $140.000 - $175.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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Crinetics Pharmaceuticals

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2015

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Crinetics Pharmaceuticals é uma empresa de biotecnologia que desenvolve terapias inovadoras para doenças endócrinas. A empresa está focada em atender necessidades médicas não atendidas, criando tratamentos para condições como acromegalia, síndrome carcinoide, síndrome de Cushing dependente de ACTH, hiperplasia adrenal congênita e outros distúrbios endócrinos. A Crinetics está comprometida em melhorar a qualidade de vida dos pacientes através de ciência de ponta e ensaios clínicos robustos. Seu pipeline inclui candidatos promissores como paltusotina, que foi aceita pelo Food and Drug Administration dos EUA para o tratamento de pacientes adultos com acromegalia. A empresa colabora com profissionais de saúde e partes interessadas para garantir que suas terapias abordem problemas reais de forma eficaz e agreguem valor para os investidores ao entrar em nichos de mercado com necessidades significativas.

Descrição

• Develop and lead end-to-end clinical supply strategies for multiple clinical programs and phases (Phase I–IV) • Design optimized supply models, including labeling, packaging, distribution, and inventory strategies • Assess and mitigate supply risks, including demand uncertainty, enrollment variability, and manufacturing constraints • Manage clinical trial supply lifecycle activities, including forecasting, demand planning, packaging, labeling, distribution, returns, and destruction • Ensure uninterrupted supply of investigational and comparator products to global clinical sites • Manage Interactive Response Technology (IRT) system builds, UAT testing, supply strategies and reconciliation activities • Partner closely with Clinical Operations, Manufacturing, Quality, Regulatory Affairs, Finance, and external vendors as required to ensure alignment on study timelines and deliverables • Serve as the clinical supply representative on study teams and governance forums • Influence study design decisions to optimize supply chain efficiency and patient experience • Lead selection, contracting, and performance management of external vendors (CMOs, depots, couriers, IRT providers) • Develop and manage clinical supply budgets, vendor quotes, proposals, and timelines • Drive cost optimization while maintaining quality and compliance • Confirm production plans and shipping schedules; develop depot/site resupply strategies and coordinate packaging schedules with third-party provider(s) to support clinical demand changes • Work with third-party providers to develop detailed project plans and timelines for the packaging, release, and distribution of clinical supplies • Coordinate the review and approval of provider documentation (distribution instructions, label proofs, packaging specifications and methods, packaging batch records, etc.) • Plan and oversee the implementation of expiry date extensions • Coordinate the assessment of and track temperature excursions during storage, receipt, or transit to clinical sites or depots • Support the transportation and disposition of returned/unused materials, as needed • Manage activities needed to source comparators and ancillary products. Plan supply strategies, labeling and distribution activities • Support the development of Standard Operating Procedures (SOPs) and guidelines related to third-party provider management, inventory management, distribution, transportation, disposition of returned/unused materials, etc. • Support CMC team as needed • Other duties as assigned.

🎯 Requisitos

• Minimum of a Bachelor’s in life sciences, nursing, business or related field with at least 12 years of related technical experience • Alternatively, a Master’s degree with 8 years of experience (an equivalent combination of experience and education may be considered) • Previous experience in Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination • Previous experience in rare diseases/oral solid dosage forms is a plus • Import and export management of drug substance and drug product • Understanding of CGMP and CGCP requirements, compendia testing, and ICH and regulatory guidelines including stability data requirements • Excellent interpersonal and communication skills (written and oral) • Experience with preparation of regulatory documents is desired • Excellent ability to work in a goal and team-oriented setting and to handle competing priorities • Flexibility within a rapidly changing environment and high attention to details • Well-developed organizational skills and the ability to thrive under pressure • Well-versed in industry trends, emerging business processes and technologies.

🏖️ Benefícios

• discretionary annual target bonus • stock options • ESPP • 401k match • top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance • 20 days of PTO • 10 paid holidays • winter company shutdown