Director Clinical Operations
2 Days Old
This rapidly growing clinical-stage biotech is actively seeking a Director of Clinical Operations to support a late-stage program and expanding development pipeline. With an anchor program in a pivotal trial and additional assets approaching the clinic, the company is entering a critical growth phase and needs an experienced clinical operations leader to join its agile, mission-driven team.
This position will report directly into senior leadership and play a key role in driving global clinical trial strategy and execution in a fast-paced, collaborative environment. The role can be based remotely on the East Coast or out of the company’s U.S. hub.
Qualifications:
10+ years of clinical operations experience, ideally in biotech or rare disease.
Proven leadership of global Phase 3 trials (NA/EU/APAC).
Strong vendor/CRO oversight and budget management skills.
Expertise in inspection readiness, TMF oversight, and eClinical systems (e.g., Medidata RAVE).
Hands-on, adaptable, and thrives in fast-paced, lean environments.
Responsibilities:
Lead global trials from start-up to closeout, ensuring quality, timelines, and budget adherence.
Oversee CRO/vendor relationships and trial deliverables.
Ensure inspection readiness and document compliance (e.g., TMF).
Manage and mentor clinical team members.
Provide strategic updates to leadership and support regulatory planning.
Seniority level Seniority level Director
Employment type Employment type Full-time
Job function Job function Project Management, Science, and Research
Industries Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
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Inferred from the description for this job Medical insurance
Vision insurance
401(k)
Paid paternity leave
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- Location:
- Phila, PA, United States
- Job Type:
- FullTime
- Category:
- Management & Operations