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Exelixis Principal Clinical DMPK Scientist
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Position:
Principal Clinical DMPK Scientist

Employer:
Exelixis

Description:

SUMMARY/JOB PURPOSE:

The Principal DMPK Scientist is highly motivated, collaborative, and innovative with experience supporting and leading nonclinical and clinical DMPK activities to support progression of oncology based novel drug candidates into and within clinical development. This individual collaborates closely with IND enabling project teams; develops and executes the DMPK and PKPD strategies necessary to optimize and facilitate the advancement of oncology candidate molecules into Clinical Development.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

  • Develop and drive the DMPK, TK and pharmacokinetics-pharmacodynamics (PKPD) strategy for development projects to support project decisions, milestones and development candidate advancement.
  • Serve as DMPK and BA representative on project teams supporting the development of novel drug candidates (small molecules, possibly biologics and antibody drug conjugates) for the treatment of diseases in Oncology, and Immuno-Oncology.
  • Collaborate with project team members (Project Management, Discovery Biology, Chemistry, Chemistry Manufacturing and Control, Regulatory), and groups within Translational Sciences (Bioanalytical, Toxicology, Translational Pharmacology, and Clinical Pharmacometrics) to generate relevant DMPK data to enable knowledge and data integration to inform and guide target validation, biomarker selection, and candidate advancement
  • Effectively communicate DMPK and PKPD strategy and knowledge to project teams, functional leaders, and other key stakeholders to ensure alignment and influence decisions.
  • Analyze and integrate in silico, physicochemical, ADME, and DMPK data to support molecule design and selection with particular attention to the impact of drug metabolism and drug-drug interactions
  • In collaboration with key partners, participate in the development of PK/PD models that will generate data and knowledge to support robust translational and biomarker strategies.
  • Coordinate and request Drug Metabolism, PK  and PKPD studies including bio-analytical support internally and externally (with CROs) in a timely manner and develop protocols and study timelines and communicate results back to teams, ensuring optimized cycle times.
  • Serve as a liaison with internal and external bio-analytical groups for method development to ensure appropriate or fit-for-purpose level of qualification (non-GLP) or validation (GLP) for sample analysis to support DMPK, TK, and PKPD sample analysis.
  • Assist in Drug Metabolism, PK, TK and PKPD report writing, report review, and preparation. Assist in the preparation of DMPK-BA sections of regulatory documents (IB, IND, NDA BLA); assist in providing responses to regulatory questions and ensure generation of appropriate reports

SUPERVISORY RESPONSIBILITIES:

  • No supervisory responsibilities
  • May provide direction to other individuals.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: 

Education/Experience:

  • BA/BS degree in Pharmaceutical Sciences or related field with 11 years of experience; or,
  • MA/MS degree in Pharmaceutical Sciences, or related field with 9 years of experience; or,
  • Doctorate (PhD) with a minimum of 5 years of experience Pharmaceutical Sciences or related field; or,
  • Equivalent combination of education and experience. 

Experience/The Ideal for Successful Entry into Job:

  • Experience in independently representing DMPK on project teams is required.
  • Expertise with PK analysis is required
  • Experience with Phoenix/WinNonlin modeling software is desired
  • Understanding of PK/PD modeling and the essential elements of assays for measuring therapeutic molecules, assessing ADME properties, and biomarkers is desirable
  • Demonstrated ability to function as principal investigator and scientific strategy leader, generating original scientific or development strategies and leading those efforts to an effective and productive outcome.
  • Recognized or emerging expert in his/her discipline
  • Experienced and demonstrated publication or patent record, with lead/senior author examples a plus

Knowledge/Skills:

  • Ability to influence, negotiate and communicate effectively with both internal and external stake holders. Ability to work well in a collaborative fast-paced team environment.
  • Highly motivated, self-driven and results-oriented person with excellent communication and presentation skills, capable to work both as team player and project driver.
  • High degree of flexibility in adapting to different projects, people and excellent networking and relationship-building (both internal and external) skills are required.
  • Passion for data analysis, solving technical problems and applying new technologies to further scientific goals
  • In-vivo and in-vitro drug metabolism including mass balance, stability evaluation, structural elucidation, enzymology, drug-drug interaction (DDI), metabolic enzyme inhibition and induction
  • Conduct and implementation of bioanalysis (BA) methodology in the ADME, PK and PD areas (regulated and non-regulated).
  • PK principles and application to noncompartmental/compartmental analysis in PK/TK/PD studies
  • Working knowledge and application to functionality of drug transporters and impact on PK and DDI
  • In-vitro - in-vivo extrapolations (IVIVE) and allometric principles with applications to first in human dose and exposure predictions
  • Knowledgeable of current regulatory landscape in DMPK area of expertise including contribution to regulatory filings (IND, NDA, investigator brochure)

WORKING CONDITIONS:

  • Environment: Primarily working in office   

ghout the calendar year.



Qualifications/Experience:

Education/Experience:

  • BA/BS degree in Pharmaceutical Sciences or related field with 11 years of experience; or,
  • MA/MS degree in Pharmaceutical Sciences, or related field with 9 years of experience; or,
  • Doctorate (PhD) with a minimum of 5 years of experience Pharmaceutical Sciences or related field; or,
  • Equivalent combination of education and experience. 

 

 

Experience/The Ideal for Successful Entry into Job:

  • Experience in independently representing DMPK on project teams is required
  • Expertise with PK analysis is required
  • Experience with Phoenix/WinNonlin modeling software is desired
  • Understanding of PK/PD modeling and the essential elements of assays for measuring therapeutic molecules, assessing ADME properties, and biomarkers is desirable
  • Demonstrated ability to function as principal investigator and scientific strategy leader, generating original scientific or development strategies and leading those efforts to an effective and productive outcome.
  • Recognized or emerging expert in his/her discipline
  • Experienced and demonstrated publication or patent record, with lead/senior author examples a plus

 

 

Knowledge/Skills:

 

  • Ability to influence, negotiate and communicate effectively with both internal and external stake holders. Ability to work well in a collaborative fast-paced team environment.
  • Highly motivated, self-driven and results-oriented person with excellent communication and presentation skills, capable to work both as team player and project driver.
  • High degree of flexibility in adapting to different projects, people and excellent networking and relationship-building (both internal and external) skills are required.
  • Passion for data analysis, solving technical problems and applying new technologies to further scientific goals
  • In-vivo and in-vitro drug metabolism including mass balance, stability evaluation, structural elucidation, enzymology, drug-drug interaction (DDI), metabolic enzyme inhibition and induction
  • Conduct and implementation of bioanalysis (BA) methodology in the ADME, PK and PD areas (regulated and non-regulated).
  • PK principles and application to noncompartmental/compartmental analysis in PK/TK/PD studies
  • Working knowledge and application to functionality of drug transporters and impact on PK and DDI
  • In-vitro - in-vivo extrapolations (IVIVE) and allometric principles with applications to first in human dose and exposure predictions
  • Knowledgeable of current regulatory landscape in DMPK area of expertise including contribution to regulatory filings (IND, NDA, investigator brochure)


Location: San Francisco Bay Area

Contact: mrodriguez@exelixis.com

Post Date: 5/10/2023 12:00:00 AM
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