Head of DMPK and Bioanalysis - Waltham, MA | Biospace
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Head of DMPK and Bioanalysis

Alkermes

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Location:
Waltham, MA
Posted Date:
12/2/2016
Position Type:
Job Code:
6880
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Alkermes is seeking a Head of DMPK and Bioanalysis to lead our overall DMPK strategy including design, execution, analysis, and interpretation of all in vitro and non-clinical ADME studies and to lead a team of bioanalytical scientists to develop bioanalytical development plans for therapeutics at various stages of discovery and development. The successful applicant will report to the VP of Clinical Research and will oversee all DMPK and BA activities starting from the research phase. The role will include managing a growing team of DMPK and BA scientists that support each product development team.

Key Responsibilities

  • Develop and execute superior DMPK and BA strategies aligned with project and company goals.
  • Manage the DMPK BA functions and scientific teams.
  • Ensure robust characterization of PK/ADME profiles during drug discovery to enable superior lead identification and drug candidate transition into development.
  • Be responsible for setting high standards of bioanalytical quality and compliance.
  • Oversee the development and qualification/validation of bioanalytical methods for pipeline compounds and for assaying samples collected during various stages of development.
  • Oversee contracted CRO activities.
  • Ensure all reports and appropriate sections of regulatory documents to support INDs, NDAs and other world-wide regulatory dossiers are provided to development teams.

Requirements

   Qualifications

The successful candidate will have a PhD with at least 10-15 years of industry experience, and will currently be in a BA/DMPK leadership position. Expert knowledge of BA and drug metabolism principles and regulatory guidances is required. The candidate must be a seasoned and experienced BA and DMPK scientific leader, be highly motivated, and have excellent interpersonal, written and oral communication skills. Prior experience with INDs, BLAs and/or NDAs is required. He/she will have demonstrated success in various aspects of DMPK sciences, and have practical experience in assay method development and troubleshooting. A strong knowledge in GxP regulations that pertain to Bioanalytical Development is required, as is experience in writing documents to be included in regulatory submissions for NDA/BLA. The position will work closely with the Research QA group to ensure that the BA activity follows stated procedures and processes and is always ready for compliance inspections by regulatory agencies.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.