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Principal Scientist/Associate Director – DMPK (Drug Metabolism and Pharmacokinetics)
Full Time
New York City, New York, United States (This job is on-site)
Job description
Scismic is supporting the growth of a new biotechnology company headquartered in New York City. The company is focused on the identification of new therapeutic and nutritional opportunities involving the gut and gut-brain axis.
We are seeking a highly creative, self-motivated DMPK leader with significant experience in drug discovery and development to work as a member of an integrated team utilizing a novel platform for the discovery of new drug targets leading to transformational therapeutics. The successful applicant will report to the Senior Director, DMPK, contribute to the drug discovery process from target validation through clinical development, and have the unique opportunity to impact both the strategy and execution of multiple therapeutic programs driven by the company's cutting-edge biology on the gut and gut-brain axis.
We are seeking a highly creative, self-motivated DMPK leader with significant experience in drug discovery and development to work as a member of an integrated team utilizing a novel platform for the discovery of new drug targets leading to transformational therapeutics. The successful applicant will report to the Senior Director, DMPK, contribute to the drug discovery process from target validation through clinical development, and have the unique opportunity to impact both the strategy and execution of multiple therapeutic programs driven by the company's cutting-edge biology on the gut and gut-brain axis.
Successful candidates for this position will have a passion for developing and executing integrated nonclinical DMPK strategies from discovery support through clinical development and a track record of driving results. Ability to think creatively and solve problems is a must.
KEY RESPONSIBILITIES
- Serve as the DMPK expert on internal project teams, from assessment of new ideas, identifying and refining key DMPK aspects of the preclinical candidate and target product profiles, supporting SAR, and driving selection/nomination of clinical candidates, while collaborating closely with Chemistry, Pharmacology, Pharmaceutical Sciences, Toxicology, and Clinical teams
- As the DMPK project representative, design and implement (internally or externally) customized in vitro assays involving the use of established and novel sub-cellular and cell-based systems (e.g. microsomes, hepatocytes, cell lines) and in vivo PK/PD experiments to enable project team decision making
- Mentor research associates and use technical knowledge in high-resolution LC-MS/MS and ADME assays to build innovative internal ADME capabilities
- Design and coordinate DMPK studies at CROs in the conduct of in vitro/in vivo ADME studies including, as needed, and up to 14C-mass balance and QWBA studies
- Prepare high-quality preclinical DMPK reports and contribute to high-quality regulatory documents, including INDs, annual reports, and Investigator Brochures (IBs)
- Provide strategic guidance to project teams and senior management including evaluation and potential impact of DMPK results on program and clinical/regulatory strategy
QUALIFICATIONS AND EDUCATION REQUIREMENTS
You must have:
- PhD in chemistry or related discipline, or equivalent industrial experience
- Prior industrial experience (>3-5 years) in the field of drug metabolism and pharmacokinetics
- Broad understanding of DMPK concepts and relevant areas such as physicochemical properties, drug-metabolizing enzyme & transporter kinetics, pharmacokinetics, mechanistic biotransformation, and analytical sciences
- Demonstrated ability to mentor scientists, build strong relationships cross-functionally and with academic and CRO partners
- Discovery / development project team experience including human PK and dose predictions and translational PK/PD models
- Familiarity with relevant health authority guidance for nonclinical DMPK evaluation and experience with the writing of technical reports in support of regulatory filings
- Excellent communication skills with an ability to communicate across a variety of audiences including team members, cross-functional project teams, senior leadership, and board meetings
- Demonstrated scientific productivity and impact, as evidenced by strong publication record and successful execution of regulatory submissions, and ability to work effectively in a collaborative setting
Additional preferred experience includes:
- Experience with gut-targeted compounds
- Experience with combination products
The expected salary range for this role in New York City is $116,250–$193,750. Please keep in mind that this range represents the pay range for all positions in the job grade within which this position falls. The actual salary offer will take into account a wide range of factors, including location.