Director Clinical Operations | Cambridge
We are currently partnering with a well-funded, clinical-stage biotech based in Cambridge focused on developing innovative therapies in areas of high unmet medical need.
As the pipeline progresses into mid-stage development, they are seeking a Clinical Operations Director to provide strategic and operational leadership across their clinical programs. This is a pivotal role within the organisation, with direct impact on study execution, team build-out, and long-term development strategy.
Role Summary:
The Clinical Operations Director will lead the design, planning, and execution of global clinical trials across Phase I and II programs, with responsibility for preparing the organisation for later-stage development. Reporting to the Chief Medical Officer, this individual will ensure operational excellence, regulatory compliance, and delivery against key clinical milestones.
This role combines strategic oversight with hands-on leadership in a lean, high-growth biotech environment.
Key Responsibilities:
Clinical Program Leadership
* Provide strategic and operational leadership across all clinical studies, from protocol development through database lock and study close-out.
* Develop and oversee study timelines, budgets, and resource plans in alignment with corporate objectives.
* Lead global CRO and vendor selection, contracting, governance, and performance oversight.
* Drive feasibility assessments, site selection strategy, and patient recruitment planning.
* Ensure adherence to ICH-GCP, FDA, EMA, and other global regulatory requirements.
* Maintain inspection readiness and lead preparation for regulatory inspections and audits.
Organisational Development
* Build, mentor, and scale the internal clinical operations team in line with pipeline growth.
* Establish and refine SOPs, operational processes, and quality standards to support scalable development.
* Partner cross-functionally with Clinical Development, Regulatory Affairs, Biometrics, CMC, and Finance to ensure integrated program delivery.
* Serve as a key contributor to senior leadership discussions on development strategy, risk management, and portfolio prioritisation.
External Representation
* Act as the primary operational interface with CROs and strategic vendors.
* Provide clear updates to executive leadership and, where required, Board stakeholders on study progress, risks, and mitigation plans.
* Support investor communications related to clinical milestones and operational readiness.
Qualifications:
* Advanced degree in life sciences, pharmacy, nursing, or related field.
* 10+ years of progressive clinical operations experience within biotech, pharma, or CRO environments.
* Demonstrated success leading global Phase I and II clinical trials; Phase III experience advantageous.
* Strong expertise in CRO oversight, vendor governance, and global trial execution.
* Deep knowledge of ICH-GCP and US/EU regulatory frameworks.
* Proven ability to build and lead high-performing teams within resource-conscious environments.
* Strong executive presence with the ability to influence cross-functional and senior stakeholders.