Associate Director, Regional Clinical Study Management

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $143.3k - $193.3k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

• 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