Senior Director, Clinical Operations Excellence & Delivery
$210k - $250kScientific Search
Location: Remote Reports to: Vice President, Clinical Operations Salary: $210-250k base plus bonus and equity Join a well-funded, clinical-stage biotechnology company advancing innovative therapies for patients with serious immunology and inflammatory diseases. Backed by significant long-term investment and led by an experienced team with a track record of successfully developing and commercializing medicines, this organization combines the scientific rigor of large pharma with the agility and speed of a biotech startup. With multiple programs advancing across respiratory and gastrointestinal indications, this is a unique opportunity to play a highly visible leadership role and directly impact the execution, scalability, and operational excellence of a growing clinical development organization. Position Summary The Senior Director, Clinical Operations Excellence & Delivery will provide strategic leadership across the Clinical Operations organization, driving operational consistency, performance, scalability, and execution excellence across a growing portfolio of clinical programs. This individual will partner closely with Clinical Operations leadership and cross-functional stakeholders to develop infrastructure, governance frameworks, performance metrics, and vendor oversight strategies that enable efficient and high-quality clinical trial execution. This is an ideal opportunity for a leader who enjoys building processes, improving operational effectiveness, and creating scalable systems within a fast-paced biotech environment. Responsibilities
- Lead the development and implementation of Clinical Operations processes, standards, governance frameworks, and best practices across the organization.
- Establish scalable operational infrastructure to support growth across a multi-program clinical development portfolio.
- Develop and oversee Clinical Operations KPIs, performance dashboards, and operational reporting frameworks.
- Partner with study teams and leadership to monitor study performance, timelines, risks, and operational health.
- Drive operational accountability through performance tracking, governance reviews, and proactive issue escalation.
- Lead the development of CRO and vendor oversight frameworks, ensuring consistent quality, performance, and accountability across external partners.
- Support vendor selection, onboarding, governance, and business review activities.
- Partner cross-functionally with Clinical Development, Biometrics, Regulatory Affairs, Clinical Quality, Clinical Supply, Finance, and other stakeholders to support integrated study execution.
- Contribute to portfolio planning, resource forecasting, and operational prioritization initiatives.
- Support inspection readiness activities and promote quality-focused operational practices across programs.
- Mentor and develop Clinical Operations team members while fostering a culture of accountability, collaboration, and operational excellence.
- Prepare and present operational updates, performance metrics, risks, and strategic initiatives to executive leadership and key stakeholders.
- Bachelor's degree required; advanced scientific, healthcare, or business degree preferred.
- 12+ years of clinical operations experience within biotech, pharmaceutical, or CRO environments.
- Significant experience leading Clinical Operations Excellence, operational strategy, portfolio oversight, delivery management, or related functions.
- Deep understanding of Phase 1–3 clinical trial execution and operational delivery models.
- Experience developing operational metrics, governance frameworks, and performance reporting systems.
- Proven CRO and vendor management experience.
- Strong understanding of ICH-GCP, FDA regulations, and global clinical trial execution.
- Demonstrated success driving operational improvements, organizational scalability, and process optimization within growing biotech environments.
- Excellent leadership, communication, and cross-functional collaboration skills.
- Experience influencing executive leadership and managing complex organizational initiatives.
- Ability to travel up to 20%.
- High-visibility leadership role with direct interaction with executive leadership.
- Opportunity to shape and build Clinical Operations infrastructure within a rapidly growing biotechnology company.
- Strong financial backing and commitment to advancing innovative therapies.
- Expanding pipeline focused on areas of significant unmet medical need.
- Fully remote work environment with meaningful influence on operational strategy and organizational growth.
Vacancy posted 3 days ago
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