Director/Senior Director, Clinical Operations at Crescent Biopharma , Inc. – Waltham, Massachusetts
Crescent Biopharma , Inc.
Waltham, Massachusetts, 02451, United States
Posted on
NewSalary:$180000 - $265000Job Function:Executive/Management
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About This Position
Director/Senior Director, Clinical Operations
$180,000 - $265,000 a year
We are seeking a
Responsibilities- Develop and execute the clinical operations strategy across Crescents 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 IIII 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
- Bachelors 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
- Crescent Biopharmas vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Companys 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.
Additional Description for Pay Transparency:
The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 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 Companys savings plan (401(k)). This position is eligible to participate in the Companys 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 - https://www.crescentbiopharma.com/careers/#benefits
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.
$180,000 - $265,000 a year
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Job Location
Waltham, Massachusetts, 02451, United States
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