Senior Scientist – Drug Metabolism & Pharmacokinetics (DMPK)

Preclinical Development             ·         New York, NY           ·            Full time

Description

Job Summary: 

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 Kallyope’s cutting-edge biology onthe 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.

About Kallyope

Kallyope is a new biotechnology company headquartered in New York City.  Founded by Richard Axel, Tom Maniatis, and Charles Zuker from Columbia University, Kallyope is focused on the identification of new therapeutic and nutritional opportunities involving the gut and gut-brain axis. The Company leverages the founders’ formidable expertise in molecular biology, neuroscience, and behavior to identify new approaches to human health. 

Kallyope is seeking creative, highly motivated individuals who are interested in working in a biotech environment that is scientifically stimulating, highly collaborative, and laser focused on translational biology.   The Company is creating an industry-leading platform employing cutting edge technologies including sequencing, genetics, circuit mapping, neural imaging and bioinformatics. By integrating and applying complementary tools and approaches to the understanding of gut and gut-brain biology, Kallyope aims to develop transformational therapeutics and consumer products to improve human health and nutrition.

The Company is headquartered in the Alexandria Center® for Life Sciences, a state-of-the-art, collaborative life science campus in the heart of Manhattan, with close proximity to New York City’s world-leading clinical and research institutions.  Kallyope has raised $488M in funding from several top-tier investors. The Company has assembled a leadership team and advisory group with a proven track record of success and strong expertise in drug discovery and translation. The founding scientific team is composed of highly creative and talented individuals with outstanding expertise in the Company’s core platform technologies.  For more information, see www.kallyope.com.

Please click here to apply.