Director, GCO Clinical Program Lead

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

💵 $171 900 - $231 900 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 1%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of BeOne Medicines

BeOne Medicines

10 000+ employés

Fondée en 2010

🧬 Biotechnologie

🏥 Santé

💊 Pharmaceutique

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines est une entreprise mondiale d’oncologie dont le siège est en Suisse. Elle découvre et développe des traitements innovants, plus abordables et plus accessibles aux patients atteints de cancer dans le monde entier. Avec un portefeuille couvrant l’hématologie et les tumeurs solides, BeOne accélère le développement de son pipeline diversifié de nouvelles thérapies grâce à ses capacités internes et à ses collaborations. Forte d’une équipe mondiale en croissance de plus de 11 000 collaborateurs présents sur six continents, l’entreprise s’engage à améliorer radicalement l’accès aux médicaments pour un bien plus grand nombre de patients qui en ont besoin.

Description

• Lead strategic operational planning and clinical operational performance for designated clinical programs • Serve as a point of escalation for study and compound-related issues • Provide strategic leadership to global Clinical Study Managers • Build, develop, retain, hire, train, mentor, and manage global gCSM teams • Oversee project delivery, goals, budgets, timelines, quality, and operational KPIs • Collaborate with GCPLs, Franchise Heads, governance teams, and cross-functional R&D leaders on program strategy and execution • Represent GCO in program governance and provide clinical operational insight • Lead or participate in KOL engagement activities and act as a function spokesperson when needed • Evaluate strategic feasibility and budget estimates during early planning and strategy changes • Allocate resources and initiate Clinical Study Team formation • Create annual program budgets and resource forecasts and track DCT goals • Create, review, maintain, and provide input on compound-level documents including IB, DSUR, and protocols • Conduct regular program review meetings and ensure studies track approved budgets and timelines • Report study status, goals, and operational KPIs and enforce quality KPIs • Evaluate preferred global vendors and participate in vendor governance meetings • Create and review performance and development plans for direct reports • Provide line management and mentorship to gCSMs • Drive scientific knowledge development and process improvement across Clinical Operations • Apply ICH/GCP and regulatory expertise to clinical trial execution

🎯 Exigences

• Bachelor or higher degree in a scientific or healthcare discipline • 10+ years’ experience in the clinical trial industry • Deep therapeutic-area expertise • Global program management skills and a global perspective • Project management exposure/experience across the entire lifecycle of multi-region/country clinical trials • Experience in a fast-paced global environment • Experience in people management and program management preferred • Knowledge of ICH/GCP Guidelines and applicable regulatory requirements • Proficiency with MS Office • Experience with project planning applications • Experience with Clinical Trial Management Systems (CTMS) • Ability to travel domestically and internationally, up to 20% • Ability to work with colleagues across various time zones

🏖️ Avantages

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness benefits • Equal opportunity employer • Reasonable accommodation in the job application process

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