Lead Clinical Operations Strategist
3 weeks ago
Workforce Genetics is a clinical-stage biotech company dedicated to advancing therapies for multi-drug resistant infections.
We are seeking a highly experienced Director of Clinical Operations to lead the design and implementation of clinical trials, focusing on combating bacterial infections, particularly multi-drug resistant pathogens.
This role demands active leadership, strategic planning, and hands-on management to ensure trials are conducted efficiently within timelines and budgets, maintaining the highest quality standards.
Responsibilities:- Oversee clinical trial planning and execution, ensuring compliance with FDA and international regulatory standards.
- Lead and manage clinical operations staff and external consultants, fostering a collaborative environment that promotes innovation and efficiency.
- Coordinate regulatory document submissions (NDAs, INDs, annual reports) to support successful product approvals.
- Manage CROs to ensure high-quality, timely, and budget-compliant studies that meet our scientific objectives.
- Collaborate with cross-functional teams for trial material delivery, leveraging expertise in project management and supply chain logistics.
Key requirements for this position include:
- A postgraduate degree in life sciences or a related field.
- No less than 15 years of clinical research experience, including roles in CROs and sponsor organizations.
- A proven track record in GCP compliance and FDA regulations, with a strong understanding of ICH-GCP guidelines.
- Experience in managing clinical studies and CROs, with a focus on operational efficiency and quality control.
The estimated salary range for this position is $140,000 - $180,000 per annum, commensurate with experience. This is a remote-based opportunity, located on the east coast of the US.
At Workforce Genetics, we offer a dynamic work environment that encourages creativity, collaboration, and continuous learning. If you are a seasoned professional with a passion for driving clinical excellence, we invite you to apply for this exciting opportunity.
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