Scientific Associate Director - PKDM (Small Molecule ADME)

Role Summary

Scientific Associate Director - PKDM (Small Molecule ADME)

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 relevant post-doc where applicable] and 4 years of directly related experience
• Or Master‚Äôs degree and 7 years of directly related experience
• Or Bachelor‚Äôs degree and 9 years of directly related experience

Preferred Qualifications

• PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees and 10+ years of experience in the Biotechnology/Pharmaceutical Industry, consulting or post-doctoral training
• Candidate should have 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