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Director/Senior Director, Clinical Operations

Crescent Biopharma

Waltham, MA permanent

Posted: March 4, 2026

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Quick Summary

We're seeking a Director/Senior Director, Clinical Operations to develop and execute the clinical operations strategy across Crescent’s oncology portfolio, in alignment with clinical development and corporate objectives.

Job Description

We are seeking a


Responsibilities:
• 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
• 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
• 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
• 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
• Oversee program and study-level budgets, resource allocation, and operational forecasts
• Ensure cost-efficient trial execution without compromising quality or timelines


Education & Experience:
• Bachelor’s degree in a scientific or health-related field, advanced degree preferred
• 10+ years of drug development and clinical operations experience, including biotech/pharma environments
• Deep oncology expertise, including early-phase and first-in-human trials
• Experience with novel oncology modalities (e.g., immunotherapy, cell or targeted therapies)
• Demonstrated leadership of matrix teams and experience building operational infrastructure
• Strong organizational, problem-solving, and conflict-resolution skills
• Ability to thrive in a fast-paced, evolving biotech environment
• Experience hiring, mentoring, and developing team members preferred
• Willingness to travel and build relationships with investigators and key opinion leaders

#LI-CBIO


What We Offer:
• 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; also, two, one-week company-wide shutdowns each year
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities


About us:
• Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates (ADCs). By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.


Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

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