Director/Senior Director, Clinical Development

🕒 April 14

🚗 Michigan – Remote

🚗 Michigan – Remote

💵 $222k - $275k / year

⏰ Full Time

🟠 Senior

👔 Director

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Esperion

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2008

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Esperion is a leading global biopharmaceutical company focused on developing innovative treatments for cardiovascular disease. Through commercial execution and international partnerships, it aims to provide broad access to its approved therapies. With a commitment to advancing its pre-clinical pipeline, Esperion is pioneering research in ACLY biology and developing next-generation inhibitors to address pressing health challenges.

📋 Description

• Ensure that Esperion assets from a clinical development perspective are aligned for success, from early clinical development to launch • Active involvement in current and future clinical development programs initiated by Esperion • Work cross-functionally to provide scientific and clinical leadership on activities including all aspects of clinical study planning, conduct, and read-out • Responsible for all clinical development responsibilities for assigned studies and/or programs • Generate responses for regulatory agency's requests for information and ensure clinical development-related items are properly addressed • Represent the company as the Clinical Development Subject Matter Expert (SME) to the FDA or other regulatory agencies as required • Create all aspects of study synopses, full protocols and protocol amendments and ensure compliance with project plans, federal regulations and GCP.

🎯 Requirements

• BS in Sciences with a minimum of 10 years of clinical design and operational experience in the pharmaceutical industry required for Director • MS in Sciences and 12+ years of clinical development experience in the pharmaceutical or biotechnology industry required for Senior Director • Extensive experience with compliance issues and strong understanding of FDA regulations, GCP and SOPs in clinical research within a pharmaceutical or biotech environment • US and EU experience preferred • Experience in lipid lowering and/or cardiovascular, metabolic, or hepatic space preferred but all therapeutic areas will be considered • Experience providing input into key regulatory documentation • Face-to-face interaction experience with FDA preferred • Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing.

🏖️ Benefits

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