Director/Senior Director, Clinical Development

At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future. Esperion is a fully remote-based company with a corporate headquarters in Ann Arbor, MI.

About the Role

The Director/Sr. Director, Clinical Development is responsible for ensuring Esperion assets are strategically aligned for success from early clinical development through launch. This role requires deep knowledge of the cardiovascular, metabolic, or hepatic therapeutic landscape and the ability to translate medical needs into an integrated clinical development plan. The position involves working cross-functionally on an early-stage compound for primary sclerosing cholangitis, providing scientific and clinical leadership in study planning, conduct, lifecycle management, scientific communication, and regulatory filings.

The ideal candidate will have strong scientific acumen, early-phase drug development experience (including clinical pharmacology), and a collaborative approach to achieving team goals.

Preferred location: Remote – US.

Responsibilities

• Lead the strategy for clinical development, including protocol design, study population, key entry criteria, outcomes of interest, and data collection to meet trial and regulatory objectives.
• Oversee all clinical development responsibilities for assigned studies and/or programs.
• Collaborate with Quality as the Clinical Development Subject Matter Expert (SME) for assigned trials.
• Work with Program Management to establish timelines and key study milestones.
• Ensure adequate resources are available for trial initiation to completion.
• Generate and review responses to regulatory agency requests for information.
• Represent the company as the Clinical Development SME to the FDA or other regulatory agencies.
• Serve as the SME for clinical development in cross-functional troubleshooting.
• Develop study synopses, full protocols, and protocol amendments in compliance with federal regulations and GCP.
• Communicate effectively with study and executive teams at appropriate levels and frequencies.
• Serve as the SME for publications, including abstracts, manuscripts, Clinical Study Reports (CSRs), and Investigator’s Brochures (IB).
• Present and interpret data for internal and external audiences.
• Perform additional duties as assigned.

Requirements

• Director: BS in Sciences with a minimum of 10 years of clinical design and operational experience in the pharmaceutical industry, or equivalent education and experience.
• Senior Director: MS in Sciences and 12+ years of clinical development experience in the pharmaceutical or biotechnology industry, or equivalent combination of education and experience.
• Extensive experience with compliance issues and a strong understanding of FDA regulations, GCP, and SOPs in clinical research.
• Experience in lipid-lowering and/or cardiovascular, metabolic, or hepatic therapeutic areas preferred (all therapeutic areas considered).
• Demonstrated expertise in early-stage clinical development; translational research experience is a plus.
• Experience providing input into key regulatory documentation; face-to-face interaction with the FDA preferred.
• Strong communication, presentation, and concise writing skills.

Benefits

• Competitive salary with a performance-based bonus program.
• Comprehensive benefits package, including a 401(k) matching plan and health insurance.
• Paid time off and holidays.