Scientific Associate Director - PKDM (Small Molecule ADME)

Role Summary

Scientific Associate Director - PKDM (Small Molecule ADME) oversees biotransformation activities for small molecule programs and serves as a project team representative. You will characterize the absorption, distribution, metabolism, excretion (ADME) and pharmacokinetic (PK) properties of SM therapeutic drug candidates to achieve their full pharmacological potential. This role focuses on applying biotransformation knowledge to support programs and optimize dose selection and preclinical study designs.

Responsibilities

• Serving as a subject matter expert of small molecule biotransformation and leading biotransformation activities to support the programs and develop strategies to reduce/mitigate risks due to metabolism.
• Leveraging current biotransformation knowledge of metabolism as well as developing/implementing novel tools to efficiently support biotransformation related activities.
• Serving as a functional PKDM project team representative (PTR) and subject matter expert on the ADME/PK of small molecule therapeutics, collaborating with scientists across our PKDM scientific community
• Leveraging specialized ADME/PK skills such as in vitro ADME, in vivo ADME, biotransformation, PK/PD, or physiologically-based pharmacokinetic modeling (PBPK) to impact project progression and decision-making
• Planning and executing mechanistic ADME/PK analyses to integrate knowledge of drug design parameters, disease pharmacology, physiology, pharmacokinetics and pharmacodynamics to optimize dose selection and preclinical study designs.
• Contributing to the analysis of pre-clinical ADME and PK data for IND and NDA filings and documenting these analyses in appropriate reports
• Building close relationships with partner functions and therapeutic areas

Qualifications

• Basic Qualifications:
  • Doctorate degree (PhD or PharmD or MD) and 4 years of directly related experience
  • Or Master’s degree and 7 years of directly related experience
  • Or Bachelor’s degree and 9 years of directly related experience
• Preferred Qualifications:
  • PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, or related fields with 10+ years of experience in the Biotechnology/Pharmaceutical Industry, consulting or post-doctoral training
  • Solid technical experience with the application of SM in vitro/in vivo ADME and pharmacokinetics fundamentals to drug discovery projects
  • Ability to drive the progression of SM discovery and development within project teams
  • Establish SM biotransformation and ADME workflows for PKDM scientists
  • Expertise with in vitro ADME, in vivo ADME, PK/PD or PBPK
  • Experience in supporting preclinical components of regulatory documentations
  • Excellent interpersonal, technical, and communication skills to lead cross-functional teams
  • Past experience as a laboratory scientist in a pharma or biotech environment
  • Excellent written and oral communication skills, attention to detail and accuracy, and interpersonal skills
  • Record of scientific contributions through peer-reviewed articles and external presentations