Clinical Operations Development Lead

Clinical Operations Development Lead

Are you leading global clinical development programmes at the asset or indication level and looking for an opportunity to directly influence clinical strategy from First-in-Human through registration and beyond?

We're partnering with a rapidly growing immunology-focused biotech that is transforming the treatment landscape for patients with severe autoimmune diseases. Following significant commercial success and continued pipeline expansion, they are seeking an experienced Clinical Operations Development Lead (CODL) to play a critical leadership role within Global Clinical Development.

This is not a traditional Clinical Trial Management position.

This is a highly strategic role for an experienced clinical operations leader who thrives in complex global development environments and wants to shape the operational strategy behind innovative therapies.

The Opportunity

As Clinical Operations Development Lead, you will provide operational leadership and strategic direction across a clinical development programme, partnering closely with Medical Development, Clinical Development, Regulatory, Project Management and Executive Leadership teams.

You will be responsible for driving clinical development plans, influencing trial design and execution strategy, overseeing budgets and timelines, leading risk management activities, and ensuring that programmes progress efficiently from early development through registration and post-approval studies.

You'll operate at indication and asset level, overseeing multiple studies rather than managing a single trial.

What You'll Be Doing

• Lead operational strategy for global clinical development programmes.
• Contribute to and shape Clinical Development Plans (CDPs).
• Partner with senior cross-functional stakeholders to drive development strategy.
• Provide oversight across Phase I-IV clinical programmes.
• Lead programme-level risk identification, mitigation and escalation activities.
• Drive consistency and excellence across study execution.
• Oversee clinical timelines, budgets and resource planning.
• Support interactions with global regulatory authorities.
• Provide leadership and coaching to Clinical Trial Leads and Clinical Trial Managers.
• Collaborate with CROs, vendors and strategic external partners.

What We're Looking For

Essential

• 15+ years of Clinical Development and Clinical Operations experience.
• Significant global clinical operations leadership experience within biotech or pharma.
• Experience leading complex multinational clinical development programmes.
• Strong understanding of clinical development strategy across the full product lifecycle.
• Experience overseeing CROs and outsourced clinical development models.
• Strong budget, governance and stakeholder management experience.
• Expert knowledge of ICH-GCP and global regulatory requirements.

Highly Desirable

• Rare disease experience.
• Autoimmune or immunology experience.
• Experience supporting programmes from First-in-Human through registration.
• Asset-level or indication-level programme leadership experience.
• Previous people leadership or matrix leadership experience.

Ideal Backgrounds

We would be particularly interested in speaking with individuals currently operating as:

• Clinical Operations Development Lead
• Director Clinical Operations
• Senior Director Clinical Operations
• Global Clinical Program Lead
• Clinical Program Lead
• Head of Clinical Operations
• Global Trial Operations Director
• Clinical Development Operations Lead
• Asset Development Lead