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Associate Director, Clinical Development, Metabolism

Reference Number: 2911
Location: PA

Our client is a major global pharmaceutical and biotech company committed to improving health worldwide.  They have asked us to assist them in their search for an Associate Director, Clinical Development, Metabolism.

The Associate Director will serve as a team member in the Metabolism Development Group, with a focus on diabetes drug development.

Major tasks and responsibilities will include:

  • Works with functional partners, responsible for the clinical development strategy for the assigned development program.
  • Provides strategic leadership on managing/addressing specific project related issues.
  • Works with Global Clinical Operations (GCO), Regulatory, and Global Medical Safety, leads a clinical team in responding to medical and compound-related issues.
  • Works with Regulatory Affairs and GCO to address any study or program-related issues, including responses to questions from Agencies and IRBs/ECs.
  • Leads a clinical team, responsible for the timely completion, content, and quality of key deliverables including protocols, reports, submissions to health agencies, as well as providing key input to statistical analysis plans and the interpretation of statistical analyses.
  • Provides input and support for other metabolic development clinical programs and maintains expertise in metabolic diseases and in relevant clinical research methodologies.

We seek candidates with the following qualifications:

  • MD (or equivalent) with board certification in internal medicine (or pediatrics) and endocrinology (or related clinical experience sufficient to have detailed expertise in endocrinology and diabetes) or nephrology is required.
  • At least 3 years of experience in clinical research and development (ideally in the conduct of Phase 2 -3b studies).
  • Recognized authority in metabolic disorders, as demonstrated by successful research and publications in metabolic disorders.
  • Detailed and thorough understanding of metabolic disorders, including diabetes and obesity and in methodology relevant to clinical research in diabetes and metabolic disorders.
  • Drug development experience is a plus.
  • Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings are required.
  • Excellent oral and written communication and presentation skills are required.
  • The ability to work with cross-functional teams in a matrix environment is preferred.
  • This position may require from 10-15% annual travel (domestic and international).

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2911. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.