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Senior Principal Scientist/Director, DMPK (DW16-07)

Watertown, MA

 

Job Summary

This position is expected to work hands-on with teams at various stages of R&D, providing expertise and leadership to support DMPK and clinical study strategies for Forma projects. Since Forma utilizes an outsourced model of experimental study, the successful candidate will be responsible for building and maintaining effective CRO relationships that support the execution of clinical and non-clinical ADME/PK work.

Major Responsibilities

  • Support for the efficient application and integration of PK and ADME studies in support of clinical, candidate selection and lead optimization programs •
    • Responsible for working with teams to identify appropriate ADME/PK issues and strategies to support candidate selection and clinical evaluation
    • Responsible for design, oversight, analysis and interpretation of ADME, PK, PK/PD studies
    • Create predictive models and analysis that support clinical, safety and pharmacology study designs
    • Writing PK sections and help review Pharmacology sections of nomination packages for lead and development candidate selection for internal and partner decision making
  • Responsible for support of PK components of IND and Phase 1 activities
    • Identification of critical studies and risk management strategies to support high quality IND applications
    • Interact with the CMC group to support strategy and their needs
    • Responsible for design, oversight and interpretation of PK, TK, metabolism and elimination studies to enable progression to IND and beyond
    • Writing and reviewing PK and Pharmacology sections of nonclinical and clinical documentation intended for clinical and regulatory submissions, including IND documentation, Protocol, lab manuals and CSRs
    • Establish provision of suitable GLP profiling and bioanalytical methods required for progression of candidates
    • Design and interpretation of PK/pharmacometric studies in support of Phase 1 and Phase 2 protocols
  • Manage interactions with external CRO to ensure high quality and on-time execution of studies.
    • Identify and qualify external vendors for ADME, PK and BA support of research and development programs

Qualifications

  • PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related discipline A minimum of 8 years of direct experience in Biotech and/or Pharmaceutical industry is required
  • Track work of working collaboratively and effectively with cross disciplinary research and development project teams
  • Experience with Phoenix WinNonlin and/or other PK software required
    • Population PK and trial simulation experience
    • Knowledge of statistics desirable
  • Demonstrated experience with the design and execution of first-in-human studies
  • Experience managing external contract research relationships.
  • Excellent verbal and written communication skills

About FORMA

FORMA Therapeutics’ scientists are passionate about discovering and developing medicines that will make a difference in oncology and other genetically driven therapeutic areas. The Company’s drug discovery engine drives screening and structure-based approaches across broad families of targets involved in tumor metabolism, epigenetics, protein homeostasis and protein-protein interactions. Leveraging a world class network of academic investigators, clinical experts and corporate partners, FORMA combines deep biological insight and chemistry expertise to rapidly create high quality, innovative drug candidates.

FORMA is headquartered in Watertown, MA near the epicenter of the Cambridge Life Sciences cluster, with additional chemistry operations in Branford, CT. www.formatherapeutics.com

Please send resumes to careers@formatherapeutics.com and reference job code # DW16-07 in the subject line.

No phone calls please.  Resumes from third party vendors will not be accepted.