Clinical Development Expert

EPM Scientific are currently working with a Pharmaceutical Company, who are seeking an External Clinical Development Expert to support a Due Diligence project focused on a Women´s Health asset. See a short summary below:

Contract Conditions:

• Start date: Mid-May 2025 (Flexible)
• Location: Europe, Remote
• Contract Type: Freelance/Consulting
• Duration: ~2 months (Mid-May to Mid-July 2025)
• Hours: Approx. 10 hours/week (variable)
• Language: Fluent English
• Project: Due Diligence for a Phase 3 Clinical Development Plan in Women´s Health

Key Responsibilities:

• Lead the development of the Phase 3 Clinical Development Plan for a Women´s Health asset.
• Conduct a comprehensive review of existing clinical data (Ph1, Ph2) to identify risks and propose mitigation strategies.
• Collaborate closely with statisticians and clinical operations to refine trial design and data interpretation.
• Engage with internal and external experts to build a robust clinical assessment.
• Prepare a Clinical Development Due Diligence report summarizing risk profile and providing an independent, data-driven recommendation.

Requirements:

• M.D. with a strong scientific and clinical background in Women´s Health.
• Experience as an investigator or principal investigator in Women´s Health trials is a plus.
• Minimum 10 years of experience in clinical practice, pharma/biotech/CRO, and corporate R&D.
• Proven expertise in late-stage clinical drug development; broader development experience is a plus.
• Solid understanding of clinical research methodology, trial design, and statistical concepts.
• Hands-on experience in clinical trial management.
• Strong leadership, strategic thinking, and communication skills.
• Ability to synthesize findings and present clear, objective risk assessments.

If this role is of interest to you, please apply directly to learn more. If not, feel free to share with your network.