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Senior/Executive Director, Clinical Development - REMOTE, US

Company: Esperion Therapeutics
Location: Ann Arbor
Posted on: September 13, 2020

Job Description:

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Clinical operations experience desirable

Senior/Executive Director, Clinical Development - REMOTE, US. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.. Full Job Description. Company Overview. Esperion is a purpose driven company with a singular focus on lipid management for everyone. Our innovative team of lipid management experts is committed to leveraging its understanding of cholesterol biosynthesis to develop innovative therapies for the treatment of patients with elevated low-density lipoprotein (LDL-C). At Esperion we are passionately committed to bringing complementary therapies to the hypercholesterolemia space that address unmet patient needs in a way that is “patient-friendly, physician-friendly and payer-friendly.”. Esperion’s corporate headquarters are located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.. Position Title: Senior/Executive Director, Clinical Development. The Senior/Executive, Clinical Director will serve as the strategic clinical development lead with accountability for the well-being of patients in clinical trials and the successful implementation of the assigned clinical development program. The clinical leader will drive the overall clinical program by providing sound medical input into the design and conduct of studies, analyzing and interpreting clinical data, and leading interactions with key internal and external stakeholders. Available as a remote position from a home-based office in the US.. Preferred Location: Remote – US. Essential Duties and Responsibilities*. Further Esperion’s clinical development program by leading a team of clinical scientists in the design and conduct of clinical trials. Provide oversight and resources to team who are responsible to draft study-related documents such as protocols, informed consent documents, Investigator Brochures, and submission-related documents such as Integrated Summary of Safety and Integrated Summary of Efficacy. Serve as medical monitor for assigned clinical trials which includes being readily available to advise on trial-related medical questions or problems during the conduct of the trial.. Assist in medical review, assessment and interpretation of clinical and safety data prepared by Clinical Scientists under their supervision to ensure that the data are correct and presented with the appropriate medical interpretation.. Work closely with pharmacovigilance counterparts providing medical input into safety reports, SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and Company Core Safety Information (CCSI), Risk Management Plans, and preparation of safety content for labels.. Serve as primary liaison with external bodies such Data Monitoring Committees (DMCs) and Steering Committees and ensure timely provision of accurate and relevant information such as safety data. Engage and promote dialogue with key thought leaders to identify opportunities for drug development. Identify possible clinical sites and contribute to investigator training. Attend teleconferences and face-to-face meetings with global regulators. Responsible for implementing alignment across policies/procedures and ensure that data generated meet monitoring and compliance standards with FDA, ICH guidelines and GCP.. additional duties and responsibilities not listed here may be required. Qualifications (Education & Experience). Medical degree required, with strong leadership skills including 12+ years direct experience in the pharmaceutical industry in a global clinical development sponsor role. Significant management experience of clinical teams in a direct reporting structure required. Internal medicine or cardiology board certification strongly preferred. Experience in lipid lowering and/or cardiovascular space preferred but all therapeutic areas will be considered.. Thorough understanding of the drug development process including practical understanding of GCP, GVP and FDA drug safety framework. Significant experience providing input into key regulatory documentation.. Excellent interpersonal skills with ability to relate well to internal and external stakeholders.. Strong communication and presentation skills as well as an ability to communicate clearly and concisely verbally and in writing. Experience presenting to a wide variety of audiences including internal teams and external stakeholders. Experience using medical monitoring software such as JReview or Spotfire.. High levels of proactivity and engagement. Notice to Agency and Search Firm Representatives: Esperion Therapeutics is not accepting unsolicited assistance from agencies and/or search firms for any job posted on this or a referring site. Please, no phone calls or emails. All resumes submitted by an agency and/or search firm to any employee at Esperion via email, the internet, or in any other form and/or method without a valid written agreement in place will be deemed the sole property of Esperion. No fees will be paid in the event that a candidate is hired by Esperion as a result of an unsolicited agency and/or search firm referral.. Esperion Therapeutics - 30+ days ago - save job. If you require alternative methods of application or screening, you must approach the employer directly to request this as Indeed is not responsible for the employer's application process.. Get job updates from Esperion Therapeutics. Singularly Focused on Lipid Management for Everybody. In spite of advances in lipid management, millions of patients still find it diff.... Thousands of employers search for candidates on Indeed

Keywords: Esperion Therapeutics, Ann Arbor , Senior/Executive Director, Clinical Development - REMOTE, US, Other , Ann Arbor, Michigan

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