Director/Senior Director, Clinical Development

Job Description

We are seeking a Director/Senior Director, Clinical Development, to ensure Esperion assets are strategically positioned for success, from the early stages of clinical development through to market launch. This role involves: - Active participation in current and future clinical development programs at Esperion. - Collaborating across functions to provide scientific and clinical expertise in all aspects of clinical study planning, execution, and data interpretation. - Assuming responsibility for all clinical development tasks related to assigned studies and programs. - Preparing responses to regulatory agency inquiries, ensuring all clinical development-related issues are adequately addressed. - Serving as the company's Clinical Development Subject Matter Expert (SME) to the FDA and other regulatory bodies as needed. - Developing comprehensive study synopses, protocols, and amendments, ensuring adherence to project plans, federal regulations, and GCP guidelines.

Qualifications

1. A Bachelor of Science (BS) degree in a scientific field is required, along with a minimum of 10 years of experience in clinical design and operations within the pharmaceutical industry for the Director position. 2. A Master of Science (MS) degree in a scientific field is necessary, accompanied by 12+ years of clinical development experience in the pharmaceutical or biotechnology sector for the Senior Director role. 3. Extensive knowledge of compliance matters and a solid understanding of FDA regulations, Good Clinical Practices (GCP), and Standard Operating Procedures (SOPs) in clinical research within a pharmaceutical or biotech environment are essential. 4. Experience in the US and EU markets is preferred. 5. Familiarity with lipid-lowering and/or cardiovascular, metabolic, or hepatic therapeutic areas is advantageous, though all therapeutic areas will be taken into consideration. 6. Proven experience contributing to crucial regulatory documentation. 7. Direct interaction experience with the FDA is preferred. 8. Excellent communication and presentation abilities, with the capability to articulate clearly and concisely in written form, are required.

Benefits

- Competitive compensation, including a performance-based bonus and equity-based incentives. - Comprehensive benefits, including a 401(k) matching plan and health coverage. - Generous paid time off and holiday allowance.