At a Glance
- Tasks: Lead global clinical development programs in Cardiovascular, Renal, or GI therapeutics.
- Company: Apsida Life Sciences partners with a global CRO to drive innovative healthcare solutions.
- Benefits: Enjoy a permanent role with opportunities for professional growth and collaboration.
- Why this job: Join a dynamic team making a real impact in healthcare through strategic project leadership.
- Qualifications: Advanced degree and 5+ years in clinical development required; expertise in specific therapeutic areas essential.
- Other info: This role offers the chance to influence high-impact clinical trials from Phase II to commercialisation.
The predicted salary is between 72000 - 108000 £ per year.
Apsida Life Sciences have partnered with a global CRO. We are seeking an experienced Senior Project Director to lead large-scale, global clinical development programs in Cardiovascular, Renal, or GI & Gastrointestinal therapeutics. The ideal candidate will have a proven track record in strategic project leadership, cross-functional collaboration, and delivering high-impact clinical trials from Phase II through commercialization. This role requires deep therapeutic expertise, strong stakeholder management, and the ability to drive operational excellence in a fast-paced, matrixed environment.
Key Responsibilities
- Strategic Leadership: Oversee end-to-end clinical development programs, ensuring alignment with corporate goals, regulatory requirements, and timelines.
- Therapeutic Expertise: Provide deep scientific and clinical insights in Cardiovascular, Renal, or GI/Gastrointestinal diseases to guide study design and execution.
- Cross-Functional Collaboration: Work closely with Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, and CROs to ensure seamless trial execution.
- Risk Management: Proactively identify and mitigate risks to study timelines, budgets, and compliance.
- Regulatory & Compliance: Ensure adherence to ICH-GCP, FDA/EMA guidelines, and other global regulatory standards.
- Vendor & CRO Oversight: Manage relationships with external partners, ensuring quality, efficiency, and cost-effectiveness.
- Budget & Resource Management: Develop and monitor project budgets, ensuring optimal resource allocation.
- Stakeholder Communication: Serve as the primary point of contact for senior leadership, investigators, and key opinion leaders (KOLs).
Qualifications & Experience
- Advanced Degree: MD, PhD, PharmD, or Master’s in Life Sciences, Business Administration, or related field.
- 5+ years in clinical development/project management within Cardiovascular, Renal, or GI/Gastrointestinal therapeutics.
- Proven Success: Track record of leading global Phase II-III trials and submissions (NDA/BLA/MAA).
- Regulatory Knowledge: Strong understanding of FDA, EMA, and ICH-GCP requirements.
- Leadership Skills: Ability to influence and lead cross-functional teams in a matrix environment.
- Vendor Management: Experience overseeing CROs, central labs, and other third-party vendors.
- Communication: Exceptional presentation, negotiation, and stakeholder management skills.
Preferred Skills
- Strong experience in Cardiovascular, Renal, GI & Gastrointestinal (no other therapeutic area experience is being considered).
- PMP or other project management certification.
- Familiarity with real-world evidence (RWE) and digital health technologies in clinical trials.
Note that this is a permanent role.
Senior Project Director employer: Apsida Life Science
Contact Detail:
Apsida Life Science Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Project Director
✨Tip Number 1
Network with professionals in the life sciences and clinical development sectors, especially those with experience in Cardiovascular, Renal, or GI therapeutics. Attend industry conferences and seminars to connect with potential colleagues and learn about the latest trends.
✨Tip Number 2
Engage with relevant online communities and forums where project directors and clinical trial managers discuss challenges and share insights. This can help you gain valuable knowledge and make connections that could lead to job opportunities.
✨Tip Number 3
Consider reaching out to current or former employees of Apsida Life Sciences or similar organisations. Informational interviews can provide you with insider knowledge about the company culture and expectations for the Senior Project Director role.
✨Tip Number 4
Stay updated on regulatory changes and advancements in clinical trial methodologies, particularly in your therapeutic areas of interest. Demonstrating your knowledge during interviews can set you apart as a candidate who is proactive and well-informed.
We think you need these skills to ace Senior Project Director
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in clinical development, particularly in Cardiovascular, Renal, or GI/Gastrointestinal therapeutics. Use specific examples of projects you've led and the outcomes achieved.
Craft a Compelling Cover Letter: In your cover letter, emphasise your strategic leadership skills and your ability to manage cross-functional teams. Mention any relevant certifications like PMP and how they enhance your project management capabilities.
Highlight Regulatory Knowledge: Clearly outline your understanding of FDA, EMA, and ICH-GCP requirements in your application. This is crucial for the role and will demonstrate your readiness to ensure compliance in clinical trials.
Showcase Communication Skills: Provide examples of how you've effectively communicated with stakeholders, including senior leadership and KOLs. Strong communication skills are essential for this position, so make sure to highlight them.
How to prepare for a job interview at Apsida Life Science
✨Showcase Your Therapeutic Expertise
Make sure to highlight your deep understanding of Cardiovascular, Renal, or GI/Gastrointestinal diseases during the interview. Prepare specific examples of how your expertise has influenced study design and execution in past projects.
✨Demonstrate Strategic Leadership
Be ready to discuss your experience in overseeing large-scale clinical development programmes. Share instances where you aligned project goals with corporate objectives and how you managed timelines and regulatory requirements effectively.
✨Emphasise Cross-Functional Collaboration
Illustrate your ability to work with various teams such as Clinical Operations, Regulatory Affairs, and Biostatistics. Provide examples of successful collaborations that led to seamless trial execution and how you managed stakeholder relationships.
✨Prepare for Risk Management Questions
Anticipate questions about how you've identified and mitigated risks in previous projects. Be prepared to discuss specific challenges you faced, the strategies you implemented, and the outcomes of those actions.