Senior Project Director

JR United Kingdom; London; On-site; GBP 60,000 - 100,000; Full time

Job description

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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

1. Strategic Leadership: Oversee end-to-end clinical development programs, ensuring alignment with corporate goals, regulatory requirements, and timelines.
2. Therapeutic Expertise: Provide deep scientific and clinical insights in Cardiovascular, Renal, or GI/Gastrointestinal diseases to guide study design and execution.
3. Cross-Functional Collaboration: Work closely with Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, and CROs to ensure seamless trial execution.
4. Risk Management: Proactively identify and mitigate risks to study timelines, budgets, and compliance.
5. Regulatory & Compliance: Ensure adherence to ICH-GCP, FDA/EMA guidelines, and other global regulatory standards.
6. Vendor & CRO Oversight: Manage relationships with external partners, ensuring quality, efficiency, and cost-effectiveness.
7. Budget & Resource Management: Develop and monitor project budgets, ensuring optimal resource allocation.
8. Stakeholder Communication: Serve as the primary point of contact for senior leadership, investigators, and key opinion leaders (KOLs).

Qualifications & Experience

1. Advanced Degree: MD, PhD, PharmD, or Master’s in Life Sciences, Business Administration, or related field.
2. 5+ years in clinical development/project management within Cardiovascular, Renal, or GI/Gastrointestinal therapeutics.
3. Proven Success: Track record of leading global Phase II-III trials and submissions (NDA/BLA/MAA).
4. Regulatory Knowledge: Strong understanding of FDA, EMA, and ICH-GCP requirements.
5. Leadership Skills: Ability to influence and lead cross-functional teams in a matrix environment.
6. Vendor Management: Experience overseeing CROs, central labs, and other third-party vendors.
7. Communication: Exceptional presentation, negotiation, and stakeholder management skills.

Preferred Skills

1. Strong experience in Cardiovascular, Renal, GI & Gastrointestinal (no other therapeutic area experience is being considered)
2. PMP or other project management certification.
3. Familiarity with real-world evidence (RWE) and digital health technologies in clinical trials.