Senior Director, Clinical Operations

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 pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody‑drug conjugates. 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. Position Overview The Senior Director, Clinical Operations, will be responsible for planning, executing, and delivering the company’s oncology clinical programs. This role oversees all aspects of clinical trial operations, including study startup, execution, monitoring, and closeout, ensuring high-quality data, operational excellence, and regulatory compliance. The ideal candidate has deep experience in oncology drug development, excels in fast‑paced biotech environments, and can build and lead high‑performing clinical operations teams. This individual may be responsible for one highly complex or multiple medium‑complexity clinical programs. This individual may have one or more direct reports. This individual will report directly into the Vice President, Head of Clinical Development Operations. Responsibilities 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. Education & Experience 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. 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. Two, one‑week company‑wide shutdowns each year. A commitment to your professional development, with access to resources, mentorship, and growth opportunities. The anticipated base pay range for this position is : $229,000 to $253,000 USD. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long‑term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found through the link below. https://www.crescentbiopharma.com/careers/#benefits E-Verify: Crescent Biopharma, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires. Equal Opportunity Employer Statement 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. #J-18808-Ljbffr