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Associate Director, DMPK

Research | Berkeley, CA | Full Time

Job Description


Plexxikon, a member of the Daiichi Sankyo Group, is a leader in the discovery and development of novel, small molecule pharmaceuticals. The company utilizes its proprietary discovery platform to successfully develop a portfolio of competitively differentiated clinical and preclinical stage compounds in a number of therapeutic areas, including two marketed drug. Zelboraf™ (vemurafenib) was the first precision medicine to be approved for the treatment of BRAF-mutant metastatic melanoma; Turalio™ (pexidartinib) was the first FDA-approved therapy for tenosynovial giant cell tumor. Plexxikon's demonstrated capability in discovery and early development uniquely positions the company to develop multiple commercial franchises for different therapeutic indications, and to create significant value for Plexxikon, Daiichi Sankyo and its collaborators.  Plexxikon's novel discovery approach, combined with experienced management and scientific teams, a broad network of scientific and clinical experts, and partnerships supporting later stage development, have been key drivers of the company's success since it began operations in 2001. 

 

We are seeking an outstanding DMPK scientist to support our drug discovery and IND-enabling programs in the Nonclnical Development Department. The qualified candidate will be a critical member of the group by leading our established ADME/PK team in support of drug discovery project teams. It is essentional that the candidate has an in-depth knowledge and proven expertise in ADME, PK, and PK/PD. This position will collaborate, align, and influence cross-functional teams to identify and mitigate key project risks related to drug absorption, metabolism, distribution, and DDI, and support IND-enabling ADME characterization, PK/PD relationship studies, and human dose prediction. This is an exceptional opportunity to work with a core discovery group within a successful biopharmaceutical company and bring drugs from ideas to the clinic.


 


Responsibilities include, but are not limited to:

  • Cooridinate and lead DMPK-related activites of projects across multiple phases, including lead discovery, lead optimization, and regulatory filings
  • Collaborate with and support multiple functional areas by implementing ADME/PK strategies that meet regulatory requirements and program goals
  • Design and manage both in-house and CRO preclinical studies to understand the ADME/PK of drug candidates to influence discovery decisions and support IND-enabling studies to support clinical development
  • Lead and mentor the ADME/PK team to support lead optimization and IND-enabling programs
  • Provide expertise and support in-house laboratory activites, such as activities using a mass spectrometer (LC-MS/MS) (i.e., developing analytical methods, troubleshooting, maintenance) and supporting in vitro experiments
  • Responsible for the analysis, interpretation, integration, and reporting of preclinical DMPK-related data generated both internally and by CROs
  • Perform human PK and efficacious dose prediction using different approaches
  • Author high quality regulatory documents (i.e., INDs and other regulatory filings)
  • Contribute significantly to corporate goals and project milestones 
  • Prepare and deliver scientific presentations and reports to communicate research results within and outside the Nonclinical Development Department
  • Maintain a command of relevant scientific literature, research method sections of DMPK publications, and evaluate implications for internal projects
  • Conduct other duties as assigned


Position Requirements & Experience:

  • Doctorate degree in Biological Sciences, Chemistry, or related field with at least 10 years of relevant research experience in the pharmaceutical or biotechnology industry
  • A track record of accomplishments (including literature publications) demonstrating technical proficiency, independent thinking, and scientific creativity
  • Experience leading a team and mentoring research associates and scientists
  • Experience performing metabolic stability, CYP inhibition, and metabolite ID studies in liver subcellular fractions, preparing and analyzing samples from biological matrices using a mass spectrometer (LC-MS/MS) as the primary analytical tool, and with sample preparation and bioanalysis of preclinical in vitro and in vivo ADME and PK studies
  • Hands-on, relevant DMPK lab experience working with a mass spectrometer 
  • Strong consideration will be given to candidates proficient in using and troubleshooting a LC-MS/MS (Sciex instrumentation is a plus)
  • Demonstrated technical proficiency, scientific creativity, problem solving ability, and capable of independently planning and executing experiments 
  • Up to date knowledge of technological and regulatory advances in the DMPK functional area 
  • Strong knowledge of drug metabolism, PK, and physicochemical property principles
  • Experience in serving as the lead ADME/PK expert on discovery and lead optimization teams
  • Experience in influencing drug discovery and development projects by applying DMPK concepts and principles
  • Demonstrated capability to mentor junior scientists and created a team atmosphere
  • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment 
  • Highly motivated and able to work in a fast-paced environment with a desire to learn and tackle new challenges 
  • Candidates must be authorized to work in the U.S

Plexxikon is a Berkeley-based small business with approximately 65 employees, located just off interstate 80.  We offer a chance to work with talented people in a collaborative environment and provide top-notch benefits including health insurance, generous time off and much more.  As an equal opportunity employer, Plexxikon is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.plexxikon.com for assistance.  For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster. 

 

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