Clinical Operations Director Lead
2 days ago
**Job Summary**
Lifelancer, a talent-hiring platform in Life Sciences, Pharma, and IT, is seeking an experienced Clinical Operations Director to join our team. This role will be responsible for leading clinical trials across all phases, including overseeing vendors.
Responsibilities:
- Accountable for delivery of assigned clinical program/studies, timelines, and resource management with focus on quality
- Partner and collaborate with cross-functional stakeholders such as the Clinical Lead and other relevant stakeholders
- Lead and oversee execution of Phase I through phase 4 trials in compliance with ICH/GCP, local regulations, and internal SOPs
- Support the selection, oversight, and management of CROs and other vendors
- Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
- Review and provide clinical operations input into relevant clinical documents
- Represent Clinical Operations on cross-functional project teams and vendor/CRO operational meetings
- Communicate study-status, cost, and issues to ensure timely decision-making by senior management
- Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
Requirements:
- Minimum of BA/BS with at least 6 years of trial and clinical program experience. Advanced degree preferred.
- Experience in Oncology indications highly desired
- Solid experience in early and late phase drug development
- Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges
- Cross-Collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
- Excellent verbal and written communication skills, in addition to excellent organizational skills
- Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
Estimated Salary:$145,000 - $175,000 per year, depending on location and experience
About Lifelancer: Lifelancer is a talent-hiring platform that connects talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains. We believe in fostering strong relationships between professionals and organizations, and we're committed to providing exceptional support throughout the hiring process.
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