Arvinas - Director of Clinical Operations (Neuroscience)
Requirements
• 12+ years of clinical operations experience, with significant hands-on leadership of early-phase clinical trials, including Phase I/II studies. • Deep expertise in neuroscience clinical trials, particularly in neurodegenerative diseases (e.g., PD, PSP, SBMA, ALS). • Demonstrated success in CRO oversight and vendor management, with a strong ability to drive performance, accountability, and quality. • Proven experience advancing programs from preclinical/IND-enabling through early clinical development. • 5+ years of people management experience, with the ability to build and lead high-performing teams. • Strong understanding of GCP, ICH guidelines, and global regulatory requirements. • Experience in biotech or fast-paced clinical-stage environments, with the ability to operate with agility and accountability. • Excellent strategic thinking, problem-solving, and risk management skills. • Strong communication and stakeholder management skills, with the ability to influence at senior levels. • Demonstrated ability to manage budgets, timelines, and competing priorities across multiple programs. • Experience with INDs and early clinical development is highly preferred. • Clinical pharmacology and/or dose-escalation study experience is desirable. • Willingness to travel as needed. • Arvinas will not be providing VISA sponsorship for this position. You must have the ability to work without a need for current or future VISA sponsorship. • The duties of this role are generally conducted in a combination of company office and home office environments. Employees must be able, with or without an accommodation use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving, analysis and dialogue; collaborate with others; maintain general availability during standard business hours. • Experience in Parkinson’s Disease, PSP, SBMA, ALS, or related neurodegenerative disorders. • Experience with rare disease trials, including patient recruitment challenges and innovative trial designs. • Familiarity with decentralized trial elements and digital health technologies. • Experience with patient registries and natural history studies. • Prior experience building or scaling clinical operations infrastructure in a growing biotech. • Education • Bachelor’s degree in Life Sciences, Pharmacy, or related field required; advanced degree preferred. • Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com
Responsibilities
• Lead end-to-end clinical operations for global early-phase neuroscience trials, ensuring delivery against timelines, budget, quality, and enrollment targets. • Serve as the primary operational lead for CRO oversight, driving accountability, performance, and partnership to ensure execution excellence and high-quality data delivery. • Provide strategic and technical leadership in the planning and execution of complex neuroscience studies, including dose-escalation, cohort expansion, and rare disease trial designs. • Translate clinical development strategy into operational plans, ensuring alignment across cross-functional stakeholders and external partners. • Build, lead, and develop a high-performing clinical operations team, including hiring, training, and resource prioritization aligned with program needs. • Establish and optimize clinical operations infrastructure, including SOPs, systems, processes, and KPIs to support scalable and compliant trial execution. • Oversee vendor selection, contracting, and management, including CROs and specialty vendors; ensure performance metrics are defined and met. • Proactively identify and mitigate operational risks, particularly for early-phase and rare disease studies. • Partner cross-functionally with Clinical Development, Medical, Regulatory, Biometrics, CMC, Supply Chain, Legal, IT, and Finance to ensure integrated execution. • Collaborate with key opinion leaders (KOLs) and investigators to inform protocol design and feasibility. • Ensure studies are conducted in compliance with GCP, ICH guidelines, and regulatory requirements, maintaining inspection readiness at all times. • Oversee clinical documentation and deliverables, including protocols, IBs, DSURs, and study reports, in collaboration with medical writing and clinical teams. • Monitor and report on clinical trial performance metrics (KPIs), including enrollment, quality, timelines, and budget. • Foster a collaborative, accountable, and execution-focused culture within the clinical operations function and across stakeholders.
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