At a Glance
- Tasks: Lead global clinical development programmes and shape operational strategies for innovative therapies.
- Company: Rapidly growing biotech transforming treatment for severe autoimmune diseases.
- Benefits: Competitive salary, dynamic work environment, and opportunities for professional growth.
- Other info: Join a collaborative team focused on groundbreaking therapies and global health.
- Why this job: Directly influence clinical strategy and make a real impact on patient care.
- Qualifications: 15+ years in Clinical Development with strong leadership and strategic skills.
The predicted salary is between 63000 - 77000 £ per year.
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
Clinical Operations Development Lead employer: Planet Pharma
Join a leading biopharmaceutical organisation in Slough, where innovation meets collaboration. As a Scientist in Antibody Formulation Development, you'll thrive in a dynamic work culture that prioritises employee growth and offers unique opportunities to contribute to groundbreaking research. With a focus on professional development and a supportive team environment, this role promises a rewarding experience for those passionate about advancing biopharma solutions.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Operations Development Lead
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Planet Pharma. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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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 Planet Pharma.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Planet Pharma. 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 Planet Pharma is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Clinical Operations Development Lead
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 Planet Pharma!
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 Planet Pharma 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 Planet Pharma!
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 Planet Pharma, 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 Planet Pharma
✨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 Planet Pharma 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 Planet Pharma’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.
