Director, DMPK

About Us

Our team is dedicated to the development of a broad pipeline of small molecules powered by unique chemistry insights to address a wide range of high unmet clinical needs.

Our company was created within 5AM Ventures' 4:59 Initiative in 2023.  We are based in Watertown, MA. 

• We are seeking an experienced leader for our Drug Metabolism and Pharmacokinetics (DMPK) strategy for our small molecule drug discovery and development pipeline. In this newly created role, you will oversee all aspects of DMPK, ensuring the seamless integration of pharmacokinetic (PK) data and modeling strategies to drive preclinical and clinical development.

• You will be responsible for advancing our understanding of drug behavior in the body, with a specific focus on the use of preclinical PK data to model and simulate human pharmacokinetic profiles. You will apply advanced pharmacokinetic modeling and simulation (PK/PD) to predict human drug exposure, optimize dosing regimens, and support decision-making in early drug development.

• You will set the DMPK strategy for our discovery programs
• We'll look to you for the establishment and oversight of activities at CROs, including in vitro ADME, PK, bioanalysis and PK/PD modeling
• Utilize preclinical pharmacokinetic (PK) and pharmacodynamic (PD) data to build and validate predictive models for human pharmacokinetics and drug behavior. Work closely with cross-functional teams to establish optimal dose projections for human clinical trials.
• Human Dose Prediction: Apply modeling and simulation techniques to determine the predicted human pharmacokinetic profile, including dose selection, bioavailability, half-life, and drug-drug interaction potential, based on animal and in vitro data.

• You will be the functional area representative for DMPK on multidisciplinary project teams
• You will design, analyze and interpret preclinical DMPK studies in support of program goals 
• You will also use a broad array of DMPK data to enable integrated analyses of biopharmaceutics, drug metabolism, PK/PD, human PK/dose projections and DDI risk 
• You will be responsible for an internal data repository
• You will work directly with our computational chemistry team to establish and refine available predictive DMPK-property tools.

• You earned your Ph.D. with a focus in pharmacokinetics, pharmacology or related discipline. 
• You have at least 10 years of experience in pharma and or a biotech setting.
• You have small molecule DMPK experience - this is a must.
• Have you spent time working specifically across multiple therapeutic areas in drug discovery? This is highly preferred.
• You have extensive experience optimizing and characterizing the ADME properties of small molecule drug candidates, supported by a strong publication record in DMPK sciences. You also bring expertise in the interplay between DMPK parameters, physicochemical and molecular properties
• Expertise in PK/PD modeling from discovery through early development. Proficient with Phoenix WinNonlin or similar. 
• Experience leading DMPK on projects particularly in discovery and early development
• Operational experience and familiarity with the drug discovery and development process, including external regulatory requirements
• You're comfortable navigating complexity and ambiguity in an environment that is constantly changing, and even thrive in this. You're poised interacting with consultants, external vendors and internal cross-functional project teams. You also have track record of achieving results in a virtual/outsourced model
• You're an articulate, open communicator with the ability to analyze, interpret and present data in a clear manner
• Not a stranger to authoring and reviewing documents, you especially have a familiarity authoring and reviewing PK sections of regulatory dossiers
• Your colleagues would describe you as an open and articulate communicator.
• You bring an openness to learn from diverse perspectives and collaborate on multidisciplinary teams.
• You have a track record of scientific vigor and creativity in carrying out research

 We are an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected characteristics.

Please note that we do not accept unsolicited resumes from recruitment agencies and external recruiters. No fees will be paid for such submissions.