We are partnered with a Biotech company approaching PIII for a pivotal asset, who are looking for a Clinical Development Consultant to join them for a contracting position until the end of 2026, for a fully remote position.
This person musty have experience in rare disease, and who can support from a medical monitoring perspective, as well as interacting with EMA.
Key Responsibilities
Provide medical oversight and monitoring for assigned clinical development programs.
Contribute to the strategic direction and execution of clinical development plans across one or more programs.
Lead the development of clinical strategies, evaluate development risks, track progress, and implement mitigation strategies in collaboration with clinical science, project management, and leadership teams.
Partner with preclinical teams to ensure supporting data packages enable transition into clinical development in accordance with global regulatory standards.
Work with cross-functional study teams to design clinical protocols and supporting documentation, including investigator brochures and regulatory materials.
Ensure clinical studies are aligned with the target product profile, scientific objectives, and regulatory expectations across participating regions.
