Sr. Scientist/Principal Scientist, Pharmacokinetics

City TherapeuticsCambridge, MA
76dOnsite

About The Position

We are seeking a highly motivated and skilled DMPK scientist to join our dynamic and growing Translational Sciences Team. This position will report to the Head of Clinical Pharmacology and Pharmacokinetics (CPPK). The successful candidate will act as a PK lead for discovery and early development programs, providing PK/PD and mechanistic modeling insights by integrating ADME and PK/PD data to drive decision making from drug candidate selection to clinical development. The ideal candidate is a hands-on scientist who thrives in an entrepreneurial, collaborative, and fast-paced environment. You will have the opportunity to directly influence strategy, design experiments, interpret data, and shape the translational approach for novel RNAi therapeutics.

Requirements

  • For Sr. Scientist, Ph.D. (3+ years), MS (7+ years) or BS (9+ years) or for Principal Scientist, Ph.D. (6+ years), MS (10+ years) or BS (12+ years) in pharmacokinetics, pharmaceutical sciences, pharmacology, or related field with prior experience as DMPK lead or translational modeler.
  • Strong experience in translational PK/PD modeling, including PBPK, compartmental, mechanistic modeling.
  • Proficiency with PKPD modeling tools such as Phoenix WinNonlin, MATLAB, R, Simcyp, NONMEM.
  • Strong background in ADME and PK principles.
  • Ability to interpret complex PK data and communicate findings in a clear and concise manner.
  • Familiar with regulatory expectations and guidance relevant to early-stage drug development.
  • Demonstrated adaptability and collaborative mindset with the ability to take on diverse responsibilities in a dynamic environment.
  • Excellent problem-solving and communication skills with the ability to convey complex quantitative data to diverse audiences.

Nice To Haves

  • Prior experience with RNAi or oligonucleotide therapeutics a plus.
  • Experience supporting IND/CTA-enabling studies or early clinical development programs.
  • Experience working with CROs and management outsourced ADME and PK studies.

Responsibilities

  • Serve as the PK lead on multidisciplinary teams, partnering with chemistry, platform biology, computational biology, clinical, regulatory, and CMC to advance discovery and early development programs.
  • Apply modeling and simulation approaches (PK/PD, mechanistic, PBPK, QSP) to enable nonclinical to clinical translation, guide dose selection, and inform clinical design.
  • Design and oversee ADME and PKPD studies, both internally and with CROs, to support drug candidate selection and regulatory submissions.
  • Conduct NCA to calculate PK and TK parameters in compliance with GLP and applicable regulatory guidelines to support IND and other regulatory submissions.
  • Prepare high-quality study summaries, technical reports, and input for regulatory documents (e.g. IND, IB, BB, etc)
  • Integrate DMPK and pharmacology data to build quantitative frameworks to inform structure-activity relationships, target validation, and molecule design.
  • Contribute to program strategy by identifying key risks with quantitative understanding.
  • Stay current with emerging trends in translational modeling and predictive ADME to help implement innovative tools and best practices.

Benefits

  • Opportunity to make a direct impact on drug discovery and development.
  • A collaborative and science-first culture where innovation is encouraged.
  • Growth potential in both scientific and strategic leadership with an expanding biotech environment.

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Education Level

Ph.D. or professional degree

Number of Employees

11-50 employees

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