Position: Director DMPK Project Leadership

Location: Indiana, USA

Department: Research & Development

Summary

We are currently working with a Global Pharmaceutical company, with a highly developing pipeline consisting of early and late stage developments within Oncology, Obesity, Immunology and Neurology. Despite their portfolio of marketed drugs, the company is still focused on its commitment to research and development.

Due to the demand of the pipeline, the company will now look for a DMPK Director / Senior Director to join the pre-clinical project team as a strategic leader, and assist in progressing the assets to IND.

Skills

• PhD in Biology/Cell Biology or relevant fields
• 7-10 years in-depth industry experience within DMPK/ADME teams
• Worked previously as a DMPK/ADME project leader or project representative
• Direct experience working with Large Molecules (antibodies, proteins, peptides, nucleic acid-based therapies)
• Experience: ADCs, RNAs, Gene Therapies
  Understanding of current regulatory guidelines and requirements, particularly those related to NDA and BLA submissions

Responsibilities

• Lead the innovation within a multidisciplinary team, with a focus on ADME studies to advance the preclinical and clinical development of the drug portfolio
• Design and execute hypothesis-driven studies to address questions related to ADME, pharmacokinetics (PK), pharmacodynamics (PD), and clinical pharmacology
• Integrate ADME, PK, and PK/PD data with discovery biology insights to identify structure-activity and structure-property relationships, guiding strategies for drug delivery and optimization
• Evaluate integrated data packages critically and conduct due diligence on assets to assess their development potential.
• Oversee the preparation of regulatory documents and communications for clinical development, such as IND, NDA, BLA, and line extensions, and coordinate with regulatory agencies worldwide
• Develop and maintain professional relationships through coaching and mentoring scientists
• Demonstrate exceptional written and verbal technical communication skills, with proven ability to lead, guide, and influence teams in decision-making

If this sounds of interest it would be great to discuss in more detail.

Please reach out via LinkedIn or at zoe.king@artorecruitment.com 📩