Senior Manager, Clinical Trial Supplies

🕒 il y a 1 mois

🏄 California – Distant

🏄 California – Remote

💵 $140 000 - $175 000 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

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Crinetics Pharmaceuticals

Site WebLinkedInTous les Emplois

201 - 500 employés

Fondée en 2015

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Crinetics Pharmaceuticals est une entreprise de biotechnologie qui développe des thérapies innovantes pour les maladies endocriniennes. L'entreprise se concentre sur le traitement des besoins médicaux non satisfaits en créant des traitements pour des affections telles que l'acromégalie, le syndrome carcinoïde, le syndrome de Cushing ACTH-dépendant, l'hyperplasie surrénale congénitale, et d'autres troubles endocriniens. Crinetics s'engage à améliorer la qualité de vie des patients grâce à une science de pointe et des essais cliniques robustes. Leur portefeuille comprend des candidats prometteurs comme le paltusotine, qui a été accepté par la Food and Drug Administration des États-Unis pour le traitement des patients adultes atteints d'acromégalie. L'entreprise collabore avec des praticiens de santé et des parties prenantes pour s'assurer que leurs thérapies répondent efficacement aux problèmes réels et construisent de la valeur pour les investisseurs en entrant dans des niches de marché avec des besoins significatifs.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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