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Senior Director, Global Clinical Operations, Study Start-Up, Americas

$206.2k - $276.2k

BeiGene, Ltd.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals who are highly motivated, collaborative, and share our passionate interest in fighting cancer. Role Summary The Senior Director, Study Start‑Up Americas leads the strategic planning and execution of study start‑up activities across clinical programs in North America, ensuring rapid, high‑quality site activation. The role provides leadership to cross‑functional teams, oversees budgets, engages key stakeholders, and drives continuous process improvements to enable timely and compliant trial initiation. The Director balances strategic leadership with hands‑on execution in an agile, fast‑paced environment, delivering successful trial outcomes. Responsibilities Leadership and Line Management: Lead, coach, and mentor regional Study Start‑Up teams, conduct performance evaluations, establish staffing strategy, partner with talent acquisition, foster cross‑functional alignment, promote a strong quality culture, and establish and monitor performance metrics. Study Start‑Up Execution and Ownership: Lead end‑to‑end study start‑up activities, oversee operational planning, regulatory and ethics submissions, contract negotiations, site activation, and performance metrics for timelines, approvals, and readiness-to‑enroll. Identify risks, develop mitigation strategies, and provide operational updates to executive leadership. Process Improvement, Innovation, and Change Leadership: Drive continuous improvement initiatives to reduce activation timelines, increase predictability, and elevate quality. Evaluate and introduce innovative tools, technologies, and automation; champion change management for new systems, SOPs, and operational models. Qualifications Extensive experience as a direct line manager with responsibility for performance management and team development. Expert knowledge of global clinical trial regulations, including ICH‑GCP, FDA, and local regional authorities. Strong expertise in global study start‑up processes—clinical trial package preparation, regulatory submissions, contracting, and site activation. Demonstrated success managing complex clinical programs across multiple regions and phases. Advanced risk management and problem‑solving abilities. Strong financial acumen, including budget forecasting and cost oversight. Ability to work independently and manage multiple priorities effectively. Experience directing initiatives, tasks, and/or responsibilities as directed by leadership or the wider business. Education Bachelor’s degree in a life sciences discipline is required; an advanced degree is preferred. At least 12 years of clinical research experience, with 6 years in clinical operations leadership roles in sponsor, biotech, or CRO settings. Computer Skills Microsoft Office Suite, Trial Management applications, analytic tools, and additional relevant applications and systems. Travel May be required as per business need. Salary Range $206,200.00 – $276,200.00 annually, with base salary or hourly range only. Additional compensation may be offered based on candidate factors and location. Benefits Medical, Dental, Vision coverage 401(k) retirement plan

FSA/HSA

Life Insurance Paid Time Off and Wellness programs Equal Opportunity Employer BeOne is committed to fair and equitable compensation practices. We are an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by applicable law. All employment is decided on the basis of qualifications, merit, and business need. #J-18808-Ljbffr BeiGene, Ltd.

Vacancy posted 3 days ago
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