Senior Director, Clinical Operations
- Strategic Leadership
- Develop and execute the clinical operations strategy across Crescent’s oncology portfolio, in alignment with clinical development and corporate objectives.
- Provide operational input into clinical development plans, study designs, timelines, and budgets.
- Build and scale operational infrastructure, systems, and processes to support rapid growth.
- Clinical Trial Oversight
- Lead end-to-end operational planning, execution, and delivery of Phase I–III oncology trials, including in first-in-human and complex trial designs.
- Oversee CRO/vendor selection, contract negotiations, budget management, and ongoing performance oversight.
- Ensure trials are conducted in accordance with GCP, ICH guidelines, FDA/EMA regulations, and internal SOPs.
- Team Leadership & Cross-Functional Collaboration
- Hire, mentor, and develop a high-performing Clinical Operations team, including Clinical Trial Managers, Clinical Research Associates, and other operational staff.
- Collaborate closely with Clinical Science, Regulatory Affairs, Biometrics, CMC, Quality, Medical Affairs, and Finance.
- Foster a culture of accountability, transparency, and continuous improvement.
- Quality, Compliance, and Risk Management
- Drive development and refinement of SOPs, quality standards, and operational best practices.
- Identify operational risks and proactively implement mitigation plans.
- Support inspection readiness and lead the clinical operations response during audits and regulatory inspections.
- Budgeting & Resource Planning
- Oversee program and study-level budgets, resource allocation, and operational forecasts.
- Ensure cost-efficient trial execution without compromising quality or timelines.
- Undergraduate degree in a scientific or health related discipline. Advanced scientific or business degree or equivalent experience desirable.
- Minimum of 10 years of experience in drug development, clinical research and operational strategy experience including responsibility ensuring studies and programs are executed to quality, timelines and budget (at least part of this time in a Biotech/Pharma environment is preferred).
- Demonstration of effective team leadership of matrix teams.
- Prior experience with novel oncology modalities (e.g., immunotherapy, cell therapy, targeted therapies).
- Experience in first-in-human or early-phase oncology trials.
- Experience in building operational systems and infrastructure in a growing biotech environment
- Independently motivated, detail oriented and good problem-solving ability (think outside of the box mentality).
- Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment.
- Enjoys building relationships with KOLs and site personnel, with a willingness to travel to establish and build relationships.
- Experience with hiring, managing, mentoring and/or developing direct reports preferred.
- Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment.
- Competitive compensation, including base salary, performance bonus, and equity.
- 100% employer-paid benefits package.
- Flexible PTO.
- Two, one-week company-wide shutdowns each year.
- A commitment to your professional development, with access to resources, mentorship, and growth opportunities.
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