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Job Description
The DMPK group within the Translational Sciences Department of Exelixis is seeking a highly motivated, collaborative, and innovative Drug Metabolism and Pharmacokinetics expert with experience leading Nonclinical and Clinical DMPK activities as a representative to support enabling progression of novel drug candidates in clinical development.The qualified scientist will collaborate closely with IND enabling project teams; developing and executing the DMPK and PKPD strategies necessary to facilitate the advancement and optimization of candidate molecules into Clinical Development.
Qualifications
ESSENTIAL DUTIES AND RESPONSIBILITIES: Develop and drive the DMPK and pharmacokinetics-pharmacodynamics (PKPD) strategy for Development projects to support project decisions and achievement of milestones. Serve as a Drug Metabolism Pharmacokinetics (DMPK) representative on project teams supporting the development of novel drug candidates (small molecules, biologics, antibody drug conjugates) for the treatment of diseases in Oncology, and Immuno-Oncology. In this role, collaborate with project team members (Project Management,, Discovery Biology and Chemistry, Regulatory, Chemistry manufacturing and Control, etc.) and groups within Translational Sciences (Bioanalytical, Toxicology, Translational Pharmacology, and Clinical Pharmacometrics) to generate relevant 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 focused 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, develop PK/PD models that will generate data and knowledge to support robust translational and biomarker strategies. Coordinate and request PK, PKPD, and bio-analytical studies in a timely manner and communicate protocols, timelines, needs and results back to team, ensuring optimized cycle times Serve as a liaison with internal and external bio-analytical groups to ensure timely reagent generation, method development and sample analysis Prepare DMPK-BA sections of regulatory documents (IB, IND, BLA); provide responses to regulatory questions and ensure generation of appropriate reports
SUPERVISORY RESPONSIBILITIES: May manage one to two individuals within the DMPK group
EDUCATION/EXPERIENCE/SKILLS: Education: Bachelor with extensive (at least 14 years) experience, Masters with substantial (at least 12 years) experience, or Doctorate (Ph.D.) with at least 6 years of experience in Pharmaceutical Sciences or related fieldExperience: Experience in independently representing and supporting DMPK functions on project teams is required Demonstrated expertise with PK analysis is required Experience with Phoenix/WinNonlin/NLME 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 important Demonstrated ability to function as principle investigator and scientific strategy leader; capable of generating original scientific or development strategies and leading those efforts to an effective and productive outcome. Recognized expert in his/her discipline Experienced and demonstrated publication or patent record, with lead/senior author examples a plus Conduct and implementation of bioanalysis (regulated and non-regulated) in the ADME, PK and PD focused areas, Drug metabolism (both in-vivo and in-vitro including enzymology and structural elucidation), Pharmacokinetics and application to noncompartmental/compartmental PK/PD/TK analyses, Functionality of drug membrane transporters (tissue expression and polarity) and impact on PK and DDI, In vitro-in vivo-extrapolations and allometric principles with application to first-in-human projections, and Knowledgeable of current regulatory landscape in DMPK area of expertise including contribution to regulatory filings (IBs, INDs, NDAs).Knowledge/Skills/Abilities: 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 and achievements
JOB COMPLEXITY: Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance Learns fast, grasps the "essence” and has flexibility to change course quickly when needed Raises the bar and is never satisfied with the status quo Creates a learning environment, open to suggestions and experimentation for improvement of workflows and outcomes Embraces the ideas of others, nurtures innovation and manages bring innovation to reality
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Additional Information
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Vacancy expired!