Director, Clinical Supply

Location
Remote
Salary
competitive salary, bonus, equity and benefits including 401k with employer match
Posted
Oct 02, 2020
Required Education
Bachelors Degree
Position Type
Full time

Company Overview

Esperion is a purpose driven company with a singular focus on lipid management for everyone.  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: Director, Clinical Supply

The Director, Clinical Supply, will be responsible to oversee and manage the clinical supply efforts supporting the clinical development process.   The position will report to the Vice President of Manufacturing Planning and Operations.   Available as a remote position from a home-based office. Travel 5-10%.

Preferred Location: Remote US

Essential Duties and Responsibilities*

  • Oversee and manage the Clinical Supply Department efforts and staff.
  • Lead clinical supply efforts to manage the needs of Clinical Development as described in protocols.
  • Plans, establishes, and manages 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 to complex, requiring in-depth understanding of Good Manufacturing Practices, project management, IVRS, and medication management.
  • Responsible for conceptualization, development, and implementation of clinical supply plans, based on clinical study protocol and clinical development plans.
  • Responsible for oversight of scheduling and delivery of investigational product (IP) including strategies for creating label and packaging design, randomization, packaging, labelling and distribution of clinical supplies.
  • Manages 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.
  • Performs supply forecast modeling. 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.
  • Provide guidance on regulations and policies to Esperion Staff in regards to drug supply.
  • Approves the need for the destruction of outdated material and makes appropriate recommendations to management.
  • Ensures uninterrupted supplies throughout the duration of a clinical study program.
  • Lead and provide guidance to management of the primary and secondary depots as well as sites to coordinate expiry updating of clinical trial material
  • Lead and provide guidance of Vendors contributing to the Clinical Supply activities in support of the BA program.
  • Provide insight to potential problem areas along with their respective solutions. As the subject matter expert, provide general Clinical Supplies insight and guidance to other functional areas.
  • Provides information and updates on a regular basis to management and executive management as needed.

*additional duties and responsibilities not listed here may be required

Qualifications (Education & Experience)

  • Bachelor’s Degree – preferred in health sciences, Biology, Chemistry, Nursing, Pharmacy or equivalent experience.
  • 10+ years of experience in clinical supply management in the pharmaceutical industry.
  • 5 years of experience leading and managing clinical supply chain teams.
  • Hands on experience with global clinical trials, IxRS and excursion management.
  • Attention to detail.
  • Excellent verbal and written communication skills.

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