Senior Director, Global Strategic Feasibility, Study Start Up

🕒 il y a 3 jours

🇺🇸 États-Unis – Télétravail

💵 $206 200 - $276 200 / 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

• Oversee strategic planning and feasibility assessments for global clinical studies • Lead the global strategic feasibility team and work with regional strategic feasibility teams • Lead Study Start-Up documentation specialists to accelerate study-level and asset documentation • Ensure global and country-level strategic feasibility during study planning • Drive high-quality study start-up documentation and predictable enrollment forecasts using data analytics and company performance curves • Establish and improve global strategic feasibility processes, procedures, systems, and study start-up documentation • Oversee global strategic feasibility proposals aligned with corporate objectives, therapeutic areas, and regional requirements • Standardize data documentation, data assets, tools, and processes globally • Drive process optimization initiatives for feasibility methodologies, tools, and metrics • Collaborate with Clinical Operations, Clinical Development, Medical Affairs, Regulatory Affairs, Biostatistics, and other stakeholders • Establish and maintain partnerships with vendors, investigative sites, and key opinion leaders • Build, lead, and mentor a high-performing feasibility and study start-up team • Identify feasibility risks and develop mitigation strategies affecting timelines, budget, and study success • Present feasibility process and tool development progress, metrics, and recommendations to senior management and stakeholders • Represent Global Clinical Operations and Global Strategic Feasibility in global projects supporting BeOne R&D goals • Provide line management and drive ownership and accountability within the team and with external stakeholders

🎯 Exigences

• Bachelor’s degree or higher in a scientific, medical or healthcare discipline • BA or BS with 12+ years of experience in Feasibility, Clinical Study Management, Personnel Management and Operations Management, or an MA/MS with 8+ years of experience • Prior experience in a leadership capacity is essential • Experience with study optimization vendors, tools, and methods • Experience managing processes and timelines associated with Study Start-Up documentation, including Informed Consent development, Lab Manual creation, and Investigator Brochures • Demonstrated process improvement experience, including mapping processes, measuring components, and delivering standardization and efficiency • Proven experience in data analysis and data interpretation to inform decision-making • Expertise in country/site identification, feasibility, and study startup strategies • Experience managing, influencing, building, and managing relationships and achieving results with senior partners in an environment with competing priorities • Strong understanding of clinical study operations, feasibility assessment, and global clinical development processes • Knowledge of multiple therapeutic areas is highly desirable • Proven ability to lead and inspire teams, including cross-functional teams in a matrix environment • Demonstrated strategic thinking and informed decision-making based on feasibility assessments and business objectives • Microsoft Office Suite, CTMS applications, EDC applications, analytic tools such as Citeline and Studytrove, and additional feasibility software • Travel as needed

🏖️ Avantages

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for 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

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