At a Glance
- Tasks: Lead global clinical trials and shape operational strategies in a dynamic biotech environment.
- Company: Emerging biotech company focused on innovative clinical solutions.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Other info: Collaborative culture with a focus on high performance and innovation.
- Why this job: Make a real impact in clinical operations and drive scientific excellence.
- Qualifications: 15+ years in clinical operations with strong knowledge of regulatory standards.
The predicted salary is between 59576 - 76000 £ per year.
This newly created Director / Senior Director, Clinical Operations position offers a rare opportunity to play a foundational role in shaping clinical operations within an emerging biotech. You will provide strategic and operational leadership across pivotal global clinical trials while helping establish scalable processes, systems, and best practices as the organisation grows.
This is a highly visible, hands-on leadership role requiring close collaboration with executive leadership, cross-functional teams, CROs, and external partners to deliver high-quality studies with speed, agility, and scientific excellence.
Partner closely with the VP of Clinical Operations on strategic and operational decisions, providing recommendations, identifying key risks, and implementing effective mitigation plans. Thrive in a dynamic, evolving environment where priorities may shift as new scientific and clinical data emerge.
Build and lead high-performing partnerships with CROs and external vendors, ensuring delivery against timelines, quality standards, and budget. Drive accountability through proactive oversight, governance, and performance management.
Compliance and Inspection ReadinessEnsure all clinical trials are conducted in compliance with ICH-GCP, SOPs, and applicable international regulatory requirements. Maintain inspection-ready Trial Master Files (TMFs) and oversee quality throughout study execution.
Risk and Issue ManagementProactively identify operational risks and implement mitigation strategies to minimise impact on timelines, budget, and study quality. Manage study budgets, forecasting, and financial tracking throughout the clinical programme. Support efficient resource planning across internal teams and external partners.
Foster a collaborative, high-performance culture suited to an innovative, early-stage biotech environment. Contribute to the development, implementation, and continuous improvement of SOPs, operational processes, and clinical infrastructure to support organisational growth.
15+ years of progressive global clinical operations experience within biotechnology and/or pharmaceutical companies. Strong working knowledge of ICH-GCP, international regulatory requirements, CTMS, eTMF, and clinical quality standards. Extensive experience managing CROs and external vendors, including governance, performance oversight, and delivery management. Strong organisational skills with exceptional attention to detail and high-quality written and verbal communication.
Director - Project Management - Life Sciences employer: APX Life Sciences
Join a dynamic biotech company that values innovation and collaboration, offering you the chance to lead impactful global Phase I clinical trials. With a strong focus on employee growth, you'll benefit from a flexible hybrid working arrangement and a competitive contract rate, all while working in a supportive environment that encourages continuous improvement and excellence in clinical operations. This role not only allows you to influence study strategy but also positions you at the forefront of cutting-edge research in a fast-paced industry.
StudySmarter Expert Advice🤫
We think this is how you could land Director - Project Management - Life Sciences
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like APX Life Sciences. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like APX Life Sciences.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like APX Life Sciences. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what APX Life Sciences is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Director - Project Management - Life Sciences
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at APX Life Sciences!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show APX Life Sciences that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at APX Life Sciences!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At APX Life Sciences, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at APX Life Sciences
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at APX Life Sciences that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with APX Life Sciences’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
