Associate Director – Development Outsourcing

🕒 vor 19 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $175.000 - $190.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Direktor

👻 Geisterscore 2%

Was es bedeutet: die Wahrscheinlichkeit, dass für diese Stelle niemand wirklich einstellt.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Jade Biosciences

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

Gegründet 2024

🏥 Gesundheitswesen

🏭 Fertigung

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Jade Biosciences ist ein Biotechnologieunternehmen im klinischen Stadium, das potenziell erstklassige Therapien entwickelt, die darauf abzielen, den Behandlungsstandard für Autoimmunerkrankungen zu revolutionieren. Sein führender Kandidat, JADE101, ist ein Antikörper, der darauf ausgelegt ist, das Zytokin APRIL (A PRoliferation-Inducing Ligand) zu hemmen und wird zur Behandlung der IgA-Nephropathie (IgAN) entwickelt. Das Unternehmen baut seine Pipeline aus Projekten in der Entdeckungsphase auf, die von Paragon Therapeutics lizenziert sind, und konzentriert sich darauf, klinische Programme voranzutreiben, um neue Behandlungen für Patienten mit Autoimmunerkrankungen bereitzustellen.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

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

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