Scientific Associate Director - PKDM (Small Molecule ADME)

Role Summary

Scientific Associate Director - PKDM (Small Molecule ADME) responsible for overseeing biotransformation activities for small molecule programs, characterizing ADME/PK properties to optimize drug candidates, and serving as a project team representative within PKDM.

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 and developing/implementing novel tools to support biotransformation related activities.
• Serving as a functional PKDM project team representative (PTR) and SME on the ADME/PK of SM therapeutics, collaborating with scientists across the PKDM community.
• Leveraging specialized ADME/PK skills such as in vitro ADME, in vivo ADME, biotransformation, PK/PD, or 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) with relevant post-doctoral experience and 4 years of directly related experience
  • Or Master’s degree with 7 years of directly related experience
  • Or Bachelor’s degree with 9 years of directly related experience
• Preferred Qualifications:
  • PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, or related fields with 10+ years of experience in Biotechnology/Pharmaceutical Industry, consulting or post-doctoral training
  • Solid technical experience with SM in vitro/in vivo ADME and pharmacokinetics fundamentals
  • Ability to drive 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 documentation
  • 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

Skills

• In vitro ADME
• In vivo ADME
• Biotransformation
• PK/PD
• PBPK
• ADME/PK data analysis
• Cross-functional collaboration

Education

• PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, or related fields (preferred)
• Alternate: PharmD or MD with relevant post-doctoral experience

Additional Requirements

• Travel expectations not specified; none listed as essential.