Sr. Principal Scientist – Pkdm – Small Molecule Project Team Representative

Sr. Principal Scientist – Pkdm – Small Molecule Project Team Representative

Requirements

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 3 years of directly related experience
• Master’s degree and 6 years of directly related experience
• Bachelor’s degree and 8 years of directly related experience

Responsibilities

• Serving as a functional PKDM representative 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

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
• Strong background serving as a PKDM functional team representative for discovery or development programs, preferably across therapeutic areas
• 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
• Lead development of scientific strategy across PKDM initiatives with a focus on development of mechanistic ADME platforms to aid in translation.
• Establish SM 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