Director/Senior Director, Clinical Development

🕒 April 14

🚗 Michigan – Remote

🚗 Michigan – Remote

💵 $222k - $275k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 33%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Esperion

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

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

• Lead clinical development strategy for assigned clinical trials and programs • Define protocol design, study populations, entry criteria, outcomes, data collection, regulatory objectives, study activities, committees, adjudication, and clinical aspects of statistical analysis plans • Own clinical development responsibilities for assigned studies and/or programs • Work with Quality as Clinical Development SME for assigned trials • Partner with Program Management to establish timelines and key study milestones • Work with the Clinical Program Lead/VP Clinical Development to ensure adequate resources from trial initiation through completion • Generate responses to regulatory agency requests for information and review responses for clinical development content • Represent the company as Clinical Development SME to the FDA and other regulatory agencies • Serve as clinical development SME for cross-functional troubleshooting • Create study synopses, full protocols, and protocol amendments compliant with project plans, federal regulations, and GCP • Ensure appropriate communication with study and executive teams • Serve as SME for publications including abstracts, manuscripts, CSRs, and IBs • Present and interpret data for internal and external audiences • Perform additional duties and responsibilities 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 applicable job experience • Extensive experience with compliance issues • Strong understanding of FDA regulations, GCP and SOPs in clinical research within a pharmaceutical or biotech environment • Experience in lipid lowering and/or cardiovascular, metabolic, or hepatic space preferred, but all therapeutic areas will be 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 experience with FDA preferred • Strong communication and presentation skills • Ability to communicate clearly and concisely in writing

🏖️ Benefits

• Performance-based bonus program • Comprehensive benefits package • 401(k) matching plan • Health insurance • Paid time off • Paid holidays • Fully remote work arrangement