Associate Director, Clinical Operations Standards and Planning
New
A
Apogee TherapeuticsBiotechnology
RemoteFull-TimeManager
Salary175,000 - 195,000 USD per year
Apply NowOpens the employer's application page
Job Details
- Experience
- 12+ years
- Required Skills
- Project ManagementResource Planning
Requirements
- Minimum 12+ years of pharmaceutical/biotech industry experience in Clinical Operations related role.
- Bachelor’s degree.
- Experience in operationalizing large, global clinical trials.
- Experience providing oversight of CRO’s and other vendors.
- Experience driving innovation in clinical trial operations.
- Extensive knowledge of drug development processes.
- Extensive knowledge of ICH-GCP guidelines.
- Extensive knowledge of 21 CFR Part 11 and major Health Authority regulations.
- Strong project management skills.
- Strong analytical and forecasting capabilities with capacity modeling experience.
Responsibilities
- Identify operational efficiencies in partnership with key CROs and vendors.
- Partner with stakeholders to ensure vendor performance aligns with expectations.
- Maintain standards to ensure consistency across programs and studies.
- Collaborate with Process Excellence and QA to ensure operational efficiency and inspection readiness.
- Oversee Clinical Operations Resource Planning and Management.
- Support the establishment and maintenance of a defined career ladder.
- Develop operational best practices to support clinical trial sites.
- Collaborate on end-to-end clinical operations process, tools, and resources.
- Lead process improvement initiatives.
View Full Description & ApplyYou'll be redirected to the employer's site
