Associate Director – Development Outsourcing

🕒 il y a 16 jours

🇺🇸 États-Unis – Télétravail

💵 $175 000 - $190 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

🗣️🇺🇸🇬🇧 Anglais requis

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Publiée sur la page carrières de Jade Biosciences, pas via un site d'emploi

Repérée par Remote Rocketship il y a 16 jours

Toujours ouverte sur le site de Jade Biosciences. Vérifiée il y a 2 heures.

Logo of Jade Biosciences

Jade Biosciences

11 - 50 employés

Fondée en 2024

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Jade Biosciences est une entreprise de biotechnologie en phase clinique qui développe des thérapies potentiellement de pointe visant à transformer le standard de soin des maladies auto-immunes. Son candidat principal, JADE101, est un anticorps conçu pour inhiber la cytokine APRIL (A PRoliferation-Inducing Ligand) et est en cours de développement pour le traitement de la néphropathie à immunoglobuline A (IgAN). La société construit son portefeuille à partir de produits en phase de découverte sous licence de Paragon Therapeutics et se concentre sur l'avancement des programmes cliniques afin d'offrir de nouveaux traitements aux patients atteints de maladies auto-immunes.

Description

• Serve as the primary Development Outsourcing lead for assigned studies and programs • Partner with cross-functional study teams and external vendors to ensure successful execution of outsourcing activities • Implement outsourcing strategies and independently manage day-to-day vendor-related activities • Advise study teams on vendor selection, contract strategy, oversight, and issue resolution • Ensure outsourcing deliverables, timelines, and decisions align with study objectives • Lead vendor sourcing and evaluation, including RFI/RFP preparation, proposal review, bid defense coordination, comparative analyses, and recommendations • Lead development, negotiation, and execution of vendor agreements, including Confidentiality Agreements, Master Service Agreements, Statements of Work, Change Orders, rate cards, and Letters of Intent • Partner with Legal, Finance, Development Operations, Clinical Quality Assurance, and other stakeholders on contracts and vendor oversight • Act as the day-to-day outsourcing representative for assigned vendors and studies • Identify and resolve operational issues, risks, and decisions; escalate significant concerns and strategic decisions to leadership • Support vendor governance by preparing materials, tracking actions, monitoring performance metrics, and ensuring commitments are executed • Monitor vendor performance and support corrective and preventive actions • Support vendor qualification, audit readiness, inspection preparedness, and oversight activities • Maintain vendor selection, contracting, governance, performance management, and issue-resolution documentation • Contribute to continuous improvement of Development Outsourcing processes, tools, templates, and best practices • Balance urgent issues, strategic priorities, and routine responsibilities across multiple concurrent activities • Exercise independent judgment, drive decisions, resolve obstacles, and ensure commitments are completed

🎯 Exigences

• 8-12 years of biotechnology, pharmaceutical, CRO, or contract research experience with significant experience in Development Outsourcing, Clinical Operations, Vendor Management, or a related function • Strong understanding of clinical development and outsourced service delivery models across Phases I-IV • Demonstrated experience leading vendor sourcing initiatives, RFP processes, bid defenses, contract negotiations, and vendor oversight activities • Experience negotiating and managing Master Service Agreements, Statements of Work, Change Orders, and other vendor-related contracts • Proven ability to independently manage complex outsourcing activities across multiple studies and stakeholders • Strong business judgment, organizational skills, and ability to prioritize effectively in a dynamic environment • Ability to identify risks, make timely decisions, and drive resolution of issues with limited direction • Strong communication, negotiation, influence, and relationship management skills • Experience collaborating effectively within cross-functional and matrixed organizations • Authorization to work in the United States verified through I-9 and E-Verify

🏖️ Avantages

• Fully remote work • Periodic/occasional travel to team and company events • Equal Opportunity employment

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