Position Title: Director/Senior Director, Clinical DevelopmentThe Director/Sr. Director, Clinical Development, is responsible for ensuring that Esperion assets from a clinical development perspective are aligned for success, from early clinical development, leading up to launch. The Director/Sr. Director, Clinical Development will possess a deep knowledge of the cardiovascular, metabolic, or hepatic therapeutic area landscape, an understanding of the clinical medical environment, and clinical development experience to translate medical needs and gaps into an integrated strategic clinical development plan. The Director/Sr. Director, Clinical Development will be responsible for working with the cross functional team focused on an early stage compound for primary sclerosing cholangitis.. The Director/Sr. Director will work cross-functionally to provide scientific and clinical leadership on activities including all aspects of clinical study planning, conduct, and read-out, lifecycle planning, scientific communication, and regulatory filings. The ideal candidate will have a strong scientific acumen, early phase 1 drug development experience including clinical pharmacology as well as the desire to work in a fast-paced environment, the ability to lead both strategic work as well as having high attention to detail, and a track record of working collaboratively to achieve team goals.
Preferred Location: Remote - US Essential Duties and 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
Qualifications (Education & Experience)- 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
- 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 as well as an ability to communicate clearly and concisely in writing.
