Associate Director, Regional Clinical Study Management

🕒 il y a 28 jours

🇺🇸 États-Unis – Télétravail

💵 $143 300 - $193 300 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 0%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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BeOne Medicines

Site WebLinkedInTous les Emplois

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

• Accountable for regional study or portfolio delivery with inspection-readiness quality, within agreed timelines and budget • Act as regional lead for one or multiple studies across an indication or program • Lead the regional clinical operations team, including external regional partners • Serve as point of escalation for regional study or portfolio issues • Develop regional tools, work instructions, and SOPs • Drive regional trial and portfolio deliverables • Lead planning and management of assigned clinical studies from feasibility through closeout • Generate and maintain regional study start-up and recruitment timelines • Drive regional trial feasibility, country allocation, and site selection • Provide regional input on global study plans • Coordinate local adaptations of global study documents and regulatory/EC/IRB submissions • Ensure regional and country information in study systems and tools is current • Coach and mentor CRAs; review and sign off monitoring reports as needed • Ensure country and site-level Trial Master File creation, maintenance, and quality control • Provide input on regional drug inventories, local drug labels, comparator drug regulatory approval, and reimbursement status • Manage regional data collection, data entry, and query resolution • Support Clinical Study Report planning and execution • Monitor compliance with protocols, SOPs, ICH/GCP, and applicable regulations • Maintain inspection readiness and prepare sites for audits and inspections • Identify regional risks, implement solutions, and share best practices • Lead improvements to study efficiency and quality • Select and manage regional study vendors • Manage and negotiate regional study budgets • Coordinate investigator fees, site payments, and patient travel reimbursement • Monitor regional resource utilization • Ensure clinical team competencies meet company requirements • Mentor junior team members and support development plans

🎯 Exigences

• Bachelor's degree in a scientific or healthcare discipline • 8+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry • Preferably master's degree in a scientific or healthcare discipline and 6+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry • Proficiency with MS Office and project planning applications • Solid leadership and management experience either as a direct line manager or cross-functional team lead • Strong written and verbal communication skills • Sound judgment and discretion in matters of significance • Ability to work independently and effectively handle multiple priorities in a fast-paced environment • Excellent interpersonal and organizational skills • Ability to influence and lead • Willingness to travel as required by business need

🏖️ Avantages

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

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