Associate Director, Clinical Operations / Senior Clinical Trial Manager

Associate Director, Clinical Operations / Senior Clinical Trial Manager

An incredible opportunity to join a stealth-mode biotech

Reports to: Head of Clinical Operations

Location: Remote, US (ideally East Coast)

Contract: Full-time

About the opportunity

An incredible opportunity has arisen to join a small, growing, stealth-mode biotechnology company as Associate Director, Clinical Operations / Senior Clinical Trial Manager.

This is a unique opportunity to join an ambitious biotech at an exciting stage of its development, working within a small, lean team where you will have high visibility, significant ownership and the opportunity to make a real impact.

Working closely with the Head of Clinical Operations, you will play a key role in driving clinical trial execution, shaping the Clinical Operations function and contributing to the company's ongoing growth and development.

This is a hands-on opportunity for someone who thrives in an entrepreneurial environment, enjoys working autonomously and wants to be part of building something from an early stage.

Key responsibilities

• Lead the operational planning, management and execution of clinical trials and development programmes, ensuring delivery against agreed timelines, budgets and quality standards.
• Develop and maintain essential clinical study documentation, including protocols, informed consent forms and study plans.
• Support ethics committee and regulatory submissions, ensuring compliance with applicable regulatory requirements and ICH-GCP.
• Lead CRO and vendor selection, qualification, contracting and ongoing oversight.
• Manage clinical study budgets, review vendor contracts and invoices, and proactively identify financial and operational risks.
• Establish and maintain strong relationships with international clinical sites, Principal Investigators and external partners, particularly across the US and EU.
• Oversee clinical trial supply activities in collaboration with internal teams and external providers.
• Provide oversight of clinical data management, EDC activities, data quality and study milestones.
• Ensure effective TMF management, sponsor oversight and ongoing inspection readiness.
• Monitor study progress, identify risks and implement solutions to ensure delivery against key milestones, including FPI, LPI, LPO and DBL.
• Work cross-functionally with Clinical Development, Regulatory, Data Management and external stakeholders to ensure successful programme delivery.

Experience, skills and knowledge

• Advanced degree in Life Sciences or a related discipline, or equivalent relevant experience.
• Strong experience within Clinical Operations in the pharmaceutical or biotechnology industry.
• Experience managing multicentre, international clinical trials, ideally across the US and EU.
• Cardiometabolic clinical development experience is strongly desired.
• Phase I and II clinical trial experience.
• Proven experience in CRO selection, vendor management and oversight.
• Strong knowledge of global clinical trial regulations, including FDA, EMA, MHRA and ICH-GCP requirements.
• Experience with clinical data management, EDC systems, TMF oversight and inspection readiness.
• Strong project management, budget management and stakeholder management capabilities.
• Excellent communication and organisational skills.

Personal attributes

• Proactive, motivated and comfortable taking ownership within a small, growing biotech.
• Strategic thinker with a hands-on approach and strong attention to detail.
• Pragmatic, solutions-focused and able to operate effectively in a fast-paced environment.
• Confident communicator with the ability to influence and collaborate across internal and external teams.
• Comfortable working autonomously within a lean team, with the confidence to take initiative and make decisions.
• Adaptable and comfortable with changing priorities in an evolving business.
• Willing to work remotely and travel nationally and internationally as required, including occasional travel to London and clinical trial sites.