Careers

Esperion is a small company doing big things. We are an exciting and fast-paced business which makes it both very demanding and very rewarding. Top-notch colleagues, innovative and important work, and unfailing commitment and pride in what we do make Esperion a great place to work.

What drives our work? Our core values:

Respect Individual dignity

The Esperion team is driven by personal pride in what we do. Our colleagues are undaunted by seemingly insurmountable obstacles, confident in their ability to rise to the challenge. They bring professionalism and integrity to their work and we’re lucky to have them. Together, we’re exploring, creating, and building upon our collective understanding of basic science to develop novel therapies for treating cardiovascular and metabolic diseases.

Commit to Vibrant Teamwork, Challenge Conventional Thinking & Innovate

Esperion is a place where competing ideas thrive, where conflict is about developing the best solution. Our processes are collaborative and iterative. We recognize that putting our multiple and diverse heads together creates better results. We push each other and support each other in our quest to develop new pathways to better health.

Encourage Continuous Curiosity to Achieve Excellence in Science

Our team is comprised of exceptionally experienced drug developers, committed to excellence in everything they do. This means we apply our expertise to design experiments, collect data, and analyze the results. It means we think critically and analytically, always seeking to learn from our efforts. And it means we have the courage and expertise to challenge conventional thinking and move innovative technologies to the forefront of medicine. We seek to understand the basic science, find its therapeutic applications to treat human disease, and make a difference in patients’ lives.

  • Financial Analyst

    Esperion’s corporate headquarters are located in Ann Arbor, MI.  The Company offers a competitive salary, stock-based compensation, and a comprehensive benefits package, including 401(k) with a match and health insurance.

    Reports To: Vice President, Finance and Administration

    Essential duties and responsibilities include but are not limited to the following:

    Develop long range market and value forecasts for drug candidates in development.

    Model various financial scenarios and prepare related business enterprise valuations.

    Participate and assist in the management of market research resources including outside vendors as well as suppliers of  primary and secondary market research data and information.

    Perform research and analytics to support business development and strategic planning activities.

    Assist in due diligence preparation for business development activities.

    Maintain competitive intelligence database and tools in the CV-Metabolic therapeutic area.

    Work closely with internal Finance colleagues for corporate needs and deliverables associated with corporate financial planning, including quarterly reforecasting.

    Analyze actual costs against budgets, track commitments and efforts with emphasis on performance against plans and contracts to aid resource and scenario planning.

    Provide ad-hoc financial market analytics as required for business purposes.

    Works in a collaborative manner with colleagues and external collaborators to support activities effectively to accomplish agreed upon deliverables.

    Requirements:

    Bachelor’s Degree in Finance or related area. Additional education, such as MBA, is preferred but not required.

    2+ years of progressive experience in finance or business development.

    Investment banking experience in the pharmaceutical/life science industry is preferred but not required.

    Strong analytical skills.

    Strong business acumen.

    Strong problem solving and investigative skills.

    Expert proficiency in the Microsoft Office suite.

    Ability to perform independent research using various scientific and commercial platforms/ databases.

    Ability to multi-task, manage multiple projects at one time, and rapidly change priorities based on business needs.

    Excellent written and verbal communication skills.

    High integrity with respect to maintenance of proprietary and confidential information.

    Composure under pressure.

    All qualified applicants are requested to submit a cover letter and CV via email to hr@esperion.com.

  • Senior Clinical Research Associate

    Esperion’s corporate headquarters are located in Ann Arbor, MI.  The Company offers a competitive salary, stock-based compensation, and a comprehensive benefits package, including 401(k) with a match and health insurance.

    Reports to: Sr. Director Clinical Development Operations

    Department: Clinical

    Essential duties and responsibilities include but are not limited to the following:

    Assist in all trial management activities within Clinical Development and Operations with minimal supervision.

    Provide support to collaborating departments where needed (e.g. Quality Assurance, Regulatory, Pharmacovigilance).

    Review monitoring reports and correspondence generated by CROs for quality control and report issues to the team in accordance with the trial specific Quality Oversight Plan.

    Create review and assess trial management and monitoring plans.

    Review CRFs, study tools, presentations and site communications.

    Assist with protocol development, research reporting, and regulatory submissions.

    Participate in investigator recruitment activities including identification and contacting of potential investigators; conduct pre-study site visits to assess the willingness and suitability of potential clinical sites.

    Schedule and conduct on-site initiation, monitoring and close-out visits during clinical studies as indicated, ensuring adherence to the study protocol, accurate data collection and adherence to all local, national and U.S. Food and Drug Administration (FDA) regulations and international regulations, where applicable, according to GCP and ICH guidelines and SOPs.

    Track patient accrual, screening and enrollment information from sites. Promote patient enrollment at clinical sites as needed to achieve enrollment projections.

    Oversee and coordinate document flow and ensure quality control and reconciliation of the electronic Trial Master File for the assigned trial.

    Communicate study-specific information to/from trial sites, documents communication with study site/ team and escalates issues to team.

    Review clinical study data, adverse event reports and ensures timely reporting and resolution.

    Other responsibilities as assigned by the supervisor.

    Education/Experience:

    BS in science, healthcare or another relevant discipline, with minimum of 5 years monitoring experience in pharmaceutical/biotechnology or CRO industry required.

    Thorough understanding of the clinical operations and regulatory process. Extensive experience with compliance issues and strong understanding of FDA regulations, GCP and/ SOPs in pharmaceutical, or biotech environment.

    All qualified applicants are requested to submit a cover letter and CV via email to hr@esperion.com.

     

  • Executive Director, Project Management

    Esperion’s corporate headquarters are located in Ann Arbor, MI.  The Company offers a competitive salary, stock-based compensation, and a comprehensive benefits package, including 401(k) with a match and health insurance.

    Reports to: Vice President, Finance and Administration

    Department: Project Management

    Essential duties and responsibilities include but are not limited to the following:

    Provide organizational leadership and support to internal and external project teams to ensure Esperion goals and product candidate development activities are achieved.

    Provide oversight to project management team by managing project plans, timelines and execution from research through clinical stages.

    Assist and provide support to cross-functional teams charged with overseeing specific tasks and stages of product development.

    As a leading member of the development team, oversee development activities and provide substantial input on the development of detailed project plans to aid in successfully completing project objectives and goals as determined by the Company and Board of Directors.

    Assess the risk to successfully completing the project objective and deliverables based on technical, regulatory, and resource aspects for task completion. This will include developing mitigation and contingency plans for highest risk / highest probability issues and will enable the organization to respond to risks as they are realized in a seamless manner so as not to delay key program timelines.

    Communicate with internal/external project stakeholders to ensure that corporate objectives for each program or product candidate are met.

    Facilitate internal decision-making processes and provide regular updates to the Leadership Team. This is includes playing an active role in the Development Leadership Sub-Team. Assist the Leadership Team and Finance function in developing project costs and integrating the project into the corporate budget and forecasting process.

    Supervise/manage direct reports within the project management function.

    Education/Experience:

    B.S. degree or advanced degree in related disciplines.

    Minimum 15 years of project/team management experience within drug development required, including prior experience in the management of team based, goal oriented late-stage development projects.

    Previous clinical development experience is required.

    Prior experience in Phase 3 and conducting a cardiovascular outcomes study is required.

    Self-motivated and highly flexible individual who is able to manage multiple tasks and priorities within a fast-paced environment.

    Strong strategic and critical thinking, diplomacy, negotiation and general communication skills.

    Expertise with MS Office suite including project management software such as MS Project.

    All qualified applicants are requested to submit a cover letter and CV via email to hr@esperion.com.

  • Director, Global Regulatory Affairs

    Esperion’s corporate headquarters are located in Ann Arbor, MI.  The Company offers a competitive salary, stock-based compensation, and a comprehensive benefits package, including 401(k) with a match and health insurance.

    Reports to: Vice President, Global Regulatory Affairs

    Department: Regulatory

    Essential duties and responsibilities include but are not limited to the following:

    Execute the regional and/or global regulatory strategy using knowledge of applicable US, EU and other regional requirements to deliver on milestones designed to achieve a rapid global approval with advantageous labeling.

    At the Director level, contribute to the development of adaptable strategic regulatory options through
    regulatory risk planning and mitigation.

    Oversee the management of timely and accurate compilation of all necessary documentation for regulatory
    submissions, including ensuring the quality, content, and format comply with regional guidelines and
    regulations.

    At the Director level, support interactions with regional and/or global regulatory agencies (specifically US/EU).

    Represent the Global Regulatory Affairs (GRA) function on clinical trial teams and communicates cross-functionally.

    Develop an effective regulatory team by facilitating regular discussions with colleagues focused on objective and timely feedback.

    Coach and mentor internal colleagues on regulatory affairs topics where relevant.

    Other responsibilities as assigned by the supervisor.

    Education/Experience:

    BS degree in a relevant discipline with a minimum of 10 years of industry experience in Regulatory Affairs in the US and EU; advanced degree preferred.

    Proven track record of successfully developing and implementing regulatory strategy for multiple submission
    types including large submissions (NDA’s, IND’s, and MAA’s) with intimate knowledge of the Common Technical Document.

    Strong knowledge and understanding of regional (US/EU) and global regulatory science and overall drug
    development processes and strategies.

    Ability to critically evaluate risks to regulatory activities and develop strategic action plans to mitigate those
    risks.

    Experience successfully building, coaching, and managing regulatory teams.

    Excellent written and oral communication skills.

    Cardiovascular experience and/or experience working with the USFDA Division of Endocrine and Metabolism Drugs is preferred.

    All qualified applicants are requested to submit a cover letter and CV via email to hr@esperion.com.

  • Associate, Regulatory Affairs

    Esperion’s corporate headquarters are located in Ann Arbor, MI. The Company offers a competitive salary, stock-based compensation, and a comprehensive benefits package, including 401(k) with a match and health insurance.

    Reports to: Manager, Regulatory Submissions

    Department/Cost Center: Regulatory/600

    Location: US – Remote

    Position Overview:

    Essential Duties and Responsibilities include but are not limited to the following:

    Responsible for document-level publishing, formatting, paper submissions compilation, and document quality control including: referencing, grammar/spelling/usage and style accuracy, check for consistency and mechanics.

    Responsible for staying abreast of US, Harmonized (ICH) eCTD and ex-US guidance.

    Manages tracking of all submissions.

    Assists with publishing, review, submission and archive of eCTD submissions, including amendments and original filings.

    Assists in developing Regulatory Operations standards and processes for paper and electronic publishing.

    Assists in developing, updating, maintaining and disseminating information on the company’s submission processes and requirements.

    Assists Regulatory Affairs and Clinical personnel with document level requirements and techniques for compliant upstream eCTD authoring.

    Qualifications (Education/Experience):

    Bachelor’s degree in related scientific discipline and a minimum 2 years of experience in regulatory affairs.

    Cardiovascular background preferred.

    Excellent oral and written communication, interpersonal and organizational skills, and attention to detail.

    Ability to consistently meet tight timelines and deadlines.

    Ability to interact effectively with management and prioritize multiple projects.

    Technical proficiency, effective problem solving and critical thinking skills.

    Ability to work in a team environment.

    All qualified applicants are requested to submit a cover letter and CV via email to hr@esperion.com.

  • Clinical Supply Associate

    Esperion’s corporate headquarters are located in Ann Arbor, MI. The Company offers a competitive salary, stock-based compensation, and a comprehensive benefits package, including 401(k) with a match and health insurance.

    Reports to: Senior Director, Clinical Development/Operations

    Department/Cost Center: Clinical/300

    Location: US – Remote

    Position Overview:

    Essential Duties and Responsibilities include but are not limited to the following:

    Plans, establishes, manages and monitors activities related to clinical supplies at the study level, to support the drug development process, in cooperation with internal and external customers and partners in compliance with global regulations. Responsible for all levels of studies, ranging from simple and complex, requiring in-depth understanding of Good Manufacturing Practices, project management, IVRS, medication management.

    Assist in the conceptualization, development, and implementation of clinical supply plans, based on clinical study protocol and clinical development plans.

    Responsible for scheduling and delivery of investigational product (IP).

    Where necessary works with external consultants and third party vendors to ensure timely and quality delivery of IP that meets study protocol, regulatory, and budgetary requirements. Ensures that key project milestones are met; negotiates and communicates supply plan timelines to internal and external customers and partners.

    Contributes to the study specifications for IVRS/IWRS studies, and provides medication management for complex studies using IVRS/IWRS and predictive tools. Ensures forecasts/demands are complete and in place for studies that are aligned with the overall program strategy.

    Reviews and analyzes the need for the destruction of outdated material.

    Ensures uninterrupted supplies throughout the duration of a clinical study program. Maintains/tracks inventory of available clinical supplies and tracks expiration dates. Coordinates with CMC, in-licensing and QA partners to manage technical and quality issues to facilitate uninterrupted supplies.

    Where necessary liaise with primary and secondary depots as well as sites to coordinate expiry updating of clinical trial material.

    Maintains and ensures compliance to all SOPs. Identifies gaps in maintaining global compliance. Provides general Clinical Supplies insight and guidance to other functional areas.

    Assist in maintaining status of material throughout the lifecycle of a project.

    Review and track the shipment temperature data.

    Qualifications (Education/Experience):

    Bachelor’s Degree – preferred in health sciences, Biology, Chemistry, Nursing, Pharmacy or equivalent experience.

    2+ years of experience in clinical supply management in the pharmaceutical industry, or experience in areas of Study Project Management, QA,Regulatory Affairs, or a position having the responsibility for the overall knowledge of the clinical study process.

    With minimum of 1+ years of experience with global clinical trials

    All qualified applicants are requested to submit a cover letter and CV via email to hr@esperion.com

  • Associate Director, Clinical Operations

    Esperion’s corporate headquarters are located in Ann Arbor, MI. The Company offers a competitive salary, stock-based compensation, and a comprehensive benefits package, including 401(k) with a match and health insurance.

    Reports to: VP Clinical Operations or Designee

    Department/Cost Center: Clinical/300

    Location: US – Remote

    Essential duties and responsibilities include but are not limited to the following:

     Provide operational leadership to internal and external resources for late phase clinical trials to achieve program and company goals.

    Responsible for management and oversight of Contract Research Organizations (CROs)/vendors.

    Lead CRO operational teams in the generation and delivery of quality recruitment plans and risk mitigation strategies.

    Monitor trial progress; ensure active management and implementation of risk mitigation strategies and engagement of CROs.

    Continued assessment of CRO resources and resolving CRO performance issues.

    Oversee study management compliance activities and ensure inspection readiness.

    Effectively manage clinical operations activities.

    Lead an operational team to analyze and deliver quality feasibility of clinical programs and protocols.

    Ensure the collection of high quality clinical data; support and/or participate in the analysis of clinical data.

    Develop clinical trial forecasts for budget based on resource requirements.

    Responsible for oversight of clinical drug supply; provide drug supply forecasts based on clinical trial requirements.

    Serve as the Subject Matter Expert (SME) on study protocol and operations and ensure proper training and education to internal and external resources.

    May develop and manage internal and external clinical site monitoring activities for clinical trials on a global level.

    Effectively communicate clinical trial updates to the VP of Clinical Operations, Executive Leadership, and other appropriate functional groups.

    Work in a collaborative manner with cross-functional personnel to accomplish agreed upon deliverables by driving organizational best practices.

    Contribute to establishing study timelines and critical milestones.

    Champion the implementation and use of harmonized, consistent processes and excellence in study management deliverables related to cost effective, timely and high quality clinical trial data.

    Participate in interdepartmental scientific and medical activities specific to implementation and conduct of clinical protocols.

    Other responsibilities as assigned by the supervisor.

    Education/Experience:

    Bachelor’s degree in a scientific discipline; or equivalent combination of education and applicable experience.

    5+ years of clinical operations experience in the pharmaceutical or biotechnology industry.

    Demonstrated leadership to constructively work across boundaries and drive decisions through the use of influence.

    Experience in study management, monitoring, and pharmaceutical business.

    Working knowledge of the processes required to operationally execute clinical trials.

    Understanding of FDA regulations, GCP, ICH guidelines and clinical research SOPs.

    Demonstrated capability to proactively manage vendor-supplied resources including experience in site monitoring.

    Effective verbal and written communication skills.

    Ability to be flexible with changing priorities and work within a fast paced environment.

    All qualified applicants are requested to submit a cover letter and CV via email to hr@esperion.com

     

  • AP Specialist/Accounting Assistant

    Esperion’s corporate headquarters are located in Ann Arbor, MI. The Company offers a competitive salary, stock-based compensation, and a comprehensive benefits package, including 401(k) with a match and health insurance.

    Reports to: Dan Hazen

    Department/Cost Center: Administrative/780

    Location: Ann Arbor

    Essential Duties and Responsibilities include but are not limited to the following:

    Manage the accounts payable and cash disbursements processes, including obtaining proper approvals, invoice processing, payment processing and vendor maintenance and communication.

    Manage the vendor contracting workflow, including tracking contract requests, routing contracts for execution, tracking and reporting contract status and organizing contract files.

    Participate in the month-end accounting close process in compliance with established reporting deadlines, including recording journal entries, preparing monthly balance sheet account reconciliations, and preparing management analyses.

    Assist on special projects as required by management and the finance team

    Qualifications (Education/Experience):

    Must be very detail-oriented.

    Ability to be proactive and work in a fast-paced environment.

    Ability to multi-task.

    Strong communication skills.

    Proficient in Microsoft Office suite, especially Excel and Word. Experience with Microsoft Great Plains a plus.

    5+ years of experience in an accounts payable role, Degree in Accounting, Finance or related area a plus; or equivalent combination of education and work experience.

    All qualified applicants are requested to submit a cover letter and CV via email to hr@esperion.com

  • Senior SAS Programmer

    Esperion’s corporate headquarters are located in Ann Arbor, MI. The Company offers a competitive salary, stock-based compensation, and a comprehensive benefits package, including 401(k) with a match and health insurance.

    Reports to: Director, Biostatistics

    Department/Cost Center: Clinical/300

    Location: US – Remote

    Essential Duties and Responsibilities include but are not limited to the following:

    Performing all SAS programming tasks required for clinical trial analysis and reporting.

    Participates in the development of and ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines.

    Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies.

    Develop standard macros and/or tools in SAS for data analysis and reporting.

    Assist with statistical quality assurance review.

    Review deliverables before transfer to either internal or external clients.

    Ensure that SAS programs developed for specific protocols are effectively portable to other protocols (Reusable code).

    They utilize SAS and other analysis software in the creation of tables, figures and listings and work closely with project managers and statisticians, as a project team member, in model design.

    Performs exploratory statistical analysis using the model provided by the statistician – analyzes, tests, and modifies computer code and model design based on findings.

    Support for pharmacovigilance activity programming may be required.

    Oversight for programming deliverables from external vendors.

    Support the regulatory submission activities; provide input into data standards and submission package planning.

    Liaison between internal and external service providers to ensure efficient and timely communication on statistical/programming projects.

    Qualifications (Education/Experience):

    BS degree in computer science or related field with a minimum of 5 years of biotech or pharmaceutical industry experience required; MS degree in computer science or related field preferred; or equivalent combination of education, training and experience.

    Experience leading SAS programming projects in the pharmaceutical industry demonstrated by the ability to independently act as the point of contact on the statistical programming for all phases of clinical trials.

    Proficient in industry standards, medical terminology, and clinical trial methodologies.

    Advanced knowledge in Base SAS, SAS/STAT, SAS Graph and SAS Macro Language.

    Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets.

    Following statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide, writes specifications for analysis datasets.

    Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements.

    Understanding of Electronic Submissions.

    Proficient in CDISC implementation of SDTM and ADaM standards.

    Recent NDA or BLA submission experience preferred.

    Timeline & deliverable management for programming outputs.

    All qualified applicants are requested to submit a cover letter and CV via email to hr@esperion.com

  • Clinical Data Manager

    Esperion’s corporate headquarters are located in Ann Arbor, MI. The Company offers a competitive salary, stock-based compensation, and a comprehensive benefits package, including 401(k) with a match and health insurance.

    Reports to: Senior Director, Clinical Development/Operations

    Department/Cost Center: Clinical/300

    Location: US – Remote

    Essential Duties and Responsibilities include but are not limited to the following:

    Maintains database results by setting and enforcing standards and controls.

    Prepares for database expansion by studying plans and requirements; coordinating design and programming.

    Keeps team informed by preparing reports on system performance and problems.

    Upgrades hardware and software by assessing transaction processing and database production options.

    Maintains database performance by troubleshooting problems.

    Accomplishes platform upgrades and improvements by conducting or overseeing system programming.

    Secures database by developing policies, procedures, and controls.

    Lead the data management activities including Case Report Form (CRF) designing, database designing, developing Data Management Plan, CRF annotation, implementing edit check programs, data entry and query status tracking, and database closure.

    Responsible for tracking important study metrics on data entry, source verification, and query status, and presenting these metrics to a cross-functional team in weekly meetings.

    Designing CRFs and eCRFs for data acquisition and data entry.

    Developing test cases and performing user acceptance testing of EDC systems.

    Qualifications (Education/Experience):

    BS degree in a life science or related field with a minimum of 5 years of CDM experience in biotech or pharmaceutical industry required; MS degree in a life science or related field preferred; or equivalent combination of education, training and experience.

    Experience leading the database lock of a clinical study preferred.

    Working knowledge of SAS or SQL preferred.

    Understanding the principles of clinical research, GCP (Good Clinical Practice), and GCDMP (Good Clinical Data Management Practices).

    Working experience with Excel associated with conditional formatting, complex formula, and macros a plus.

    Excellent understanding of CDISC data models a plus.

    Ability to use a combination of Electronic Data Capture (EDC) systems and/or other internal or commercial software tools and proven ability to learn and apply new software quickly as projects require.

    Knowledge of clinical research and related regulatory requirements.

    All qualified applicants are requested to submit a cover letter and CV via email to hr@esperion.com