WEP Clinical · 13 hours ago
Senior Director, Clinical Operations
United States
Full-time
Remote
Director/Executive
10+ years expWEP Clinical is a mission-driven organization dedicated to advancing clinical research and transforming lives. The Senior Director of Clinical Operations provides global leadership for clinical program delivery, ensuring the highest standards of quality and compliance while managing key sponsor relationships and operational performance.
BiotechnologyInformation TechnologyPharmaceutical
Responsibilities
Lead and oversee all global clinical operations functions, including Clinical Project Management, Site Management, and Clinical Monitoring, ensuring studies are delivered on time, within scope, and to the highest quality standards
Serve as a senior operational advisor to leadership on feasibility, resourcing, timelines, and risks, providing guidance for portfolio planning and program execution
Act as the primary operational contact for sponsors, maintaining transparency, resolving escalations, and aligning operational strategies with client expectations
Identify, mitigate, and escalate operational risks; ensure adherence to global regulatory requirements (ICH-GCP, FDA, EMA, PMDA) and internal SOPs
Oversee global site selection, activation, monitoring, and performance; drive investigator engagement, timely recruitment, and high-quality data delivery
Implement governance structures, KPIs, and dashboards; monitor performance and drive continuous improvement across regions and programs
Lead global vendor strategy, including selection, contracting, performance management, and integration with internal operations to optimize delivery
Champion adoption of clinical systems (CTMS, eTMF, IRT, eCOA, etc.) and digital tools to enhance operational visibility, efficiency, and decision-making
Drive continuous improvement initiatives, scalable delivery frameworks, and best practices to ensure consistent, compliant, and efficient study execution
Partner with Business Development to develop operational strategies, budgets, proposals, and bid defenses, supporting organizational growth and client engagement
Lead global resource forecasting, capacity planning, and budget management to ensure efficient allocation and cost-effective program delivery
Build, mentor, and lead high-performing global teams, fostering collaboration, accountability, inclusion, and leadership development across Clinical Operations
Qualification
Required
Bachelor's degree in Life Sciences, Pharmacy, or a related field
10+ years of experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industry, with a strong focus on clinical operations, or an equivalent combination of experience, education, and expertise
Proven success in leading, scaling, and inspiring global or regional clinical operations teams
Strong leadership and people-development skills, with a track record of mentoring high-performing teams
Deep expertise in Good Clinical Practice (GCP), clinical trial regulations, and ethical guidelines across Europe
Extensive experience managing clinical trial budgets, site feasibility assessments, and vendor partnerships
Strategic thinker with exceptional problem-solving, decision-making, and negotiation abilities
Demonstrated ability to drive change, implement innovative technologies, and optimize clinical trial operations
Excellent communication, collaboration, and stakeholder management skills, with the ability to influence effectively at all levels
Preferred
advanced degree (MD, PhD, or MSc)
Benefits
Medical, dental, and vision insurance, FSA, HSA
Voluntary short-term and long-term disability insurance
Voluntary life insurance
401K safe harbor plan and company match
Paid vacation, holiday, and sick time
Paid maternity & paternity leave
Company
WEP Clinical
WEP Clinical is a specialist pharma services company that works with drug developers.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
TJC
2021-11-17Private Equity
Leadership Team
Robert Goodman
Chief Commercial Officer (CCO)
Recent News
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