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- Tasks: Lead global clinical trials and ensure operational excellence in a high-growth biotech.
- Company: Well-funded biotech in Cambridge focused on innovative therapies.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Other info: Dynamic environment with opportunities for mentorship and collaboration across teams.
- Why this job: Join a pivotal role that shapes the future of healthcare through innovative clinical operations.
- Qualifications: Advanced degree and 10+ years in clinical operations with proven leadership skills.
The predicted salary is between 72000 - 108000 £ per year.
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:
- 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.
- 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.
- 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.
Director Clinical Operations employer: Hlx Life Sciences
Contact Detail:
Hlx Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Clinical Operations
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech field, especially those who might know about opportunities at companies like the one you're eyeing. A personal introduction can make all the difference.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s pipeline and recent developments. Show them you’re not just interested in the role but also passionate about their mission and how you can contribute to their success.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a thank-you note that highlights a key point from your conversation. It keeps you fresh in their minds and shows your enthusiasm for the position.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re proactive and genuinely interested in joining the team.
We think you need these skills to ace Director Clinical Operations
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Clinical Operations Director. Highlight your experience in leading global clinical trials and any specific achievements that align with the job description. We want to see how your background fits perfectly with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your skills can contribute to our mission. Be sure to mention your experience with regulatory compliance and team leadership, as these are key for us.
Showcase Your Leadership Skills: In both your CV and cover letter, make sure to showcase your leadership skills. We’re looking for someone who can build and mentor teams, so share examples of how you've successfully led teams in the past. This will help us see you as a strong fit for our high-growth environment.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy and ensures your application goes directly to us. Plus, we love seeing candidates who take the initiative to connect with us directly!
How to prepare for a job interview at Hlx Life Sciences
✨Know Your Stuff
Make sure you’re well-versed in the specifics of clinical operations, especially around Phase I and II trials. Brush up on ICH-GCP guidelines and be ready to discuss how you've successfully led global trials in the past.
✨Show Your Leadership Skills
This role is all about leadership, so come prepared with examples of how you've built and mentored teams. Think about times when you’ve driven operational excellence and how you can translate that into this new position.
✨Understand the Company’s Vision
Research the biotech's pipeline and their focus areas. Be ready to discuss how your experience aligns with their goals and how you can contribute to their long-term development strategy.
✨Prepare for Regulatory Questions
Since regulatory compliance is key, anticipate questions about your experience with FDA and EMA requirements. Have specific examples ready that demonstrate your ability to maintain inspection readiness and lead audits.