Note: The job is a remote job and is open to candidates in USA. Esperion is a pharmaceutical company developing innovative medicines to help patients achieve their health goals. The Director/Senior Director, Clinical Development will provide scientific and clinical leadership for early-stage clinical development programs, including clinical study planning, execution, analysis, lifecycle planning, scientific communications, and regulatory filings. The role will collaborate cross-functionally and serve as a clinical development subject matter expert for assigned programs and regulatory interactions.
Responsibilities
- Lead the strategy of clinical development responsibilities including, but not limited to, the following aspects of assigned clinical trials: protocol design, study population and key entry criteria, and outcomes of interest; data to be collected to accomplish the objectives of the trial and any regulatory objectives (i.e. labeling, end of phase II meeting, etc.), important study activities required to accomplish the trial or regulatory objectives (i.e. Committees needed, adjudication, etc.), and clinical aspects of the statistical analysis plan
- Responsible for all clinical development responsibilities for assigned studies and/or programs
- Works with Quality as Clinical Development SME for assigned trials
- Works with Program Management to establish timelines of clinical development activities and key study milestones
- Works with Clinical Program Lead/VP Clinical Development to ensure adequate resources are available to conduct the trial from initiation to completion for clinical development activities or other activities as assigned under this person's management
- Generates responses for regulatory agency's requests for information and reviews other responses to 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
- Serve as SME for clinical development for any cross functional groups where troubleshooting is required
- Create all aspects of study synopses, full protocols and protocol amendments and ensure these documents are compliant with project plans, federal regulations and GCP
- Ensure appropriate communication to the study team and the executive team at the appropriate level and frequency
- Serve as the SME in publications reporting data including but not limited to abstracts, manuscripts, CSRs, IB, etc
- Present and interpret data for both internal and external audiences
- Additional duties and responsibilities as assigned
Skills
- Director: BS in Sciences with a minimum of 10 years of clinical design and operational experience in the pharmaceutical industry required or equivalent education and experience
- Senior Director: MS in Sciences and 12+ years of clinical development experience in the pharmaceutical or biotechnology industry required; or equivalent combination of education and applicable job experience. Extensive experience with compliance issues and strong understanding of FDA regulations, GCP and/ SOPs in clinical research within a pharmaceutical or biotech environment
- Demonstrated expertise in early-stage clinical development; translational research experience is a plus
- Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing
- 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
Benefits
- Performance-based bonus program
- 401(k) matching plan
- Health insurance
- Paid time off
- Paid holidays
- Fully remote work arrangement
Company Overview