Remote Director, Clinical Development (Cardio/Metabolic)

Esperion; Ann Arbor (MI); On-site; USD 180,000 - 240,000; Full time

Job summary

Esperion is seeking a Director/Senior Director, Clinical Development to lead strategic clinical development initiatives for early-stage assets progressing toward launch. The role requires deep cardiovascular/metabolic/hepatic therapeutic area knowledge and extensive dialogue with regulatory agencies.

The position supports a remote-based work model within the US, with leadership across cross-functional teams including clinical operations, regulatory, and medical affairs to translate scientific

Qualifications

• Director requires BS in Sciences with 10+ years clinical design and operational experience; Senior Director requires MS with 12+ years in clinical development.
• Experience with lipid lowering or cardiovascular/metabolic/hepatic spaces is preferred but all areas considered.
• Strong knowledge of FDA regulations, GCP, and SOPs in clinical research within pharma/biotech.
• Excellent written and verbal communication, and ability to present data clearly to diverse audiences.
• Ability to lead strategic work and manage cross-functional teams in a fast-paced environment.

Responsibilities

• Lead the strategy of clinical development activities across assigned trials and programs, including protocol design, study population, endpoints, and regulatory objectives.
• Serve as Clinical Development SME to FDA or other regulatory agencies as required.
• Provide cross-functional leadership with Quality, PM, and Clinical Program Lead to ensure timely milestones and resource allocation.
• Create study synopses, full protocols, and amendments compliant with project plans, federal regulations, and GCP.
• Present and interpret data for internal and external audiences; communicate with executive teams.

Skills

Clinical development

Regulatory knowledge (FDA)

Leadership/communication

Cross-functional collaboration

Education

BS in Sciences with 10+ years clinical design/ops

MS in Sciences with 12+ years clinical development

Job description

Esperion is seeking a Director/Senior Director, Clinical Development to lead strategic clinical development initiatives for early-stage assets progressing toward launch. The role requires deep cardiovascular/metabolic/hepatic therapeutic area knowledge and extensive dialogue with regulatory agencies.

The position supports a remote-based work model within the US, with leadership across cross-functional teams including clinical operations, regulatory, and medical affairs to translate scientific