Senior Project Director - #1092236

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: