Lead Drug Metabolism Scientist
4 hours ago
NMD Pharma is dedicated to advancing life-changing therapies for patients with neuromuscular diseases. We are currently seeking a highly experienced Lead Drug Metabolism Scientist to join our team. In this role, you will be responsible for leading drug metabolism, PK/PD activities and contributing as a subject matter expert in our cross-functional teams.
About the Role:
This is an exciting opportunity to shape the future of our company by contributing to the development of innovative therapies. You will be responsible for planning and executing drug metabolism and PK/PD activities, guiding strategies and ensuring alignment with our clinical development objectives.
Responsibilities:
- Design, monitor, analyze, and interpret PK studies, providing PK and PK/PD modeling from non-clinical studies and clinical trials.
- Design, monitor, and interpret in vitro and in vivo drug metabolism studies performed at CRO's (non-GLP and GLP).
- Use PK/PD modeling and simulation tools to perform human dose predictions.
- Develop and implement DMPK activities that align with overall development strategies from lead selection and throughout clinical development.
- Represent DMPK in cross-functional teams, driving decision-making and influencing clinical study designs.
- Write high-quality reports and regulatory documentation, including DMPK sections in Investigator Brochures, study protocols, regulatory submissions (IND/IMPD, NDA/MAA), etc.
Requirements:
- PhD or Master's degree in pharmaceutical sciences, pharmacology, or a related field, combined with 5+ years of industry experience.
- Proficiency with PK/PD software such as WinNonlin, R, or MATLAB.
- Solid expertise in discovery and development drug metabolism, PK/PD, DDI, and bioanalytical development of small molecules or peptide therapeutics.
- Experience in working with CROs and performing studies according to GLP with a comprehensive understanding of ICH guidelines.
- Strong interpersonal and communication skills, with a proven ability to work independently while being a strong collaborative member in cross-functional teams.
- Excellent oral and written English communication skills.
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