Job Title: Director/Senior Director Clinical Operations – CNS, Gene Therapy
Location: Hybrid. Three days a week in central London office
Compensation: Base salary between £120,000 – £150,000 + annual bonus and meaningful stock options in high growth business.
We are currently partnered with a stealth mode TechBio company to help them appoint an experienced operational leader to drive delivery across their innovative gene therapy programs in neurological and psychiatric diseases, initially focused on Parkinson’s disease with the plan to explore additional indications.
Reporting directly to the C-Suite, the Clinical Operations Lead will be responsible for leading their late stage asset through the rest of development and into market entry and a potential asset sale, combining strong clinical development and operational expertise with an entrepreneurial, technology driven mindset.
This is a highly empowered role for someone who looks beyond traditional clinical operations and is motivated by creating success across the full product lifecycle, focusing on high quality clinical execution while also supporting with trial related insights that can serve regulators, payers, physicians and HTA bodies.
The ideal candidate is decisive, accountable and comfortable navigating in a high energy, high growth and driven environment who is excited to build new capabilities rather than simply maintain existing processes. You will bring the expertise of an experience drug developer with the curiosity and openness of embedding AI solutions to improve success and timelines.
Responsibilities
Clinical Set-up and Execution
• Support trial design, planning and setup including vendor, country and site selection
• Ensure the timely and accurate completion of necessary regulatory applications across
jurisdictions, including Health authorities, as well as GMO bodies, IRBs, site-specific
committees and others
• Drive the operational management and execution of clinical development programs in a
hands-on, highly organized and proactive manner
• Oversee, monitor and control CROs, vendors, and study teams to ensure high-quality delivery,
timeline adherence, budget control and operational excellence
• Anticipate operational risks and bottlenecks, and implement pragmatic solutions to maintain
program momentum and delivery timelines
• Engage with investigators and site personnel to drive strong patient recruitment
• Ensure the integrity and quality of clinical trial data, oversee data reconciliation, support safety
surveillance, support data quality and consistency assessments and contribute to safety
review committees
• Align & engage with our development partners throughout the different programs
Innovation & Healthcare Technology
• Challenge conventional approaches and identify opportunities to accelerate clinical development while maintaining high trial quality
• Evaluate and integrate emerging AI solutions and innovative operational approaches (direct or through vendors) to optimise trial execution, patient enrolment, trial management, and safety monitoring
• Explore and advance innovative clinical trial strategies and technologies, including proactive engagement with regulators and stakeholders to support adoption
Program Strategy
• Drive program management and trial execution with a forward-looking mindset, supporting early evidence for registration, reimbursement, payer discussion and commercial launch
• Identify practical opportunities within the phase III program to generate launch-relevant insights, including patient journey, treatment patterns, endpoint optimisation, site feedback, and real-world evidence opportunities
• Lead structured KME/site engagement to build scientific advocacy, understand adoption barriers, and strengthen launch readiness from the clinical program onward
Required skills & qualifications
- 10+ years of relevant experience in clinical operations, clinical development operations, or clinical program leadership within biotech, pharma, or CRO environments
- Demonstrated experience leading Phase II/III or pivotal clinical trials, ideally in multi- country or global settings
- Proven ability to manage CROs, vendors, site coordination, budgets, timelines, risks, and quality deliverables in a hands-on, solution-oriented manner
- Ideally experienced with running late stage clinical trials within the CNS Therapeutic area, and experience with Cell and Gene Therapies is advantageous.
- Experience in a small biotech or high growth environment would be seen as a bonus. It’s not essential, but the environment would be very different to that of large pharma or top 5 CRO.
To discuss this opportunity further please reach out to Chris Gibson on cgibson@barringtonjames.com
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