Careers

Senior Scientist/Assoc. Direcor, Quantitative ADME Sciences, Drug Disposition (DMPK) at Decibel Therapeutics
Boston, MA, US
Position Overview & Responsibilities:

As a member of the quantitative ADME sciences group, you will be responsible for providing in-vitro ADME, in vivo pharmacokinetic (PK), and PK/PD guidance to Decibel’s project teams. The primary focus of this individual will be helping to build Decibel’s drug discovery pipeline. However, responsibilities of this position will expand as Decibel’s programs progress into clinical development. As one of the key early hires for the company, you will have the opportunity to establish and grow industry leading ADME/PK support capabilities (through external CROs or internally via platform building) that are applicable to the inner ear. This person will be a key functional leader and stakeholder to ensure we achieve our goal of developing a strong pipeline of breakthrough drugs to protect, repair and restore hearing. This is an excellent opportunity for a driven individual looking for a broad-based experience in a fast-paced, dynamic, biotech start-up environment.



Specifically, the candidate will:

Help drive programs forward by being a drug disposition subject matter expert on project teams
Manage external drug disposition efforts at contract research organizations including ADME/PK studies and regulated bioanalysis (nonclinical TK and clinical PK)
Develop ADME/PK/BioA infrastructure to meet near-term and long-term vision and enhance our understanding of inner ear disposition
In collaboration with pharmacology colleagues, conduct PK/PD analysis to establish exposure/response relationships
In collaboration with non-clinical safety/toxicology, conduct TK analysis to establish exposure/toxicity relationships
Employ allometric scaling and PK translation principles to predict human PK from pre-clinical animal species; help guide dosing strategy in FIH studies and estimate TI
Write relevant pharmacokinetic sections of regulatory filings (IND/CTA, NDA/MAA)
Establish and implement quantitative ADME sciences standard operating procedures and work cross functionally to build a cohesive SOP infrastructure
Work cross functionally to build data archiving/visualization capabilities that are scalable with organizational growth
Manage internal full-time or contract drug disposition scientists


Requirements:

PhD with 8+ years of experience in drug disposition/DMPK. Candidates with MS or BA/BS could be considered based on experience and qualifications
Experience/expertise in small molecule bioanalysis required. Experience in large molecule (peptide, protein) experience is a plus
Use of industry standard PK analysis software (WinNonlin) is required. Experience with other PK analysis platforms (eg nonmem) and/or PB/PK platforms (eg simcyp) is a plus
Ability to work in a collaborative fashion with many different disciplines both internally and with external collaborators
Must be a team player with a proven track record of success in highly matrixed work environments
Ability to multi-task and prioritize to manage multiple projects simultaneously
Must have excellent oral and written communication/presentation skills

To be considered for a position at Decibel Therapeutics, please submit your CV with the title of the position in the subject line.