AbbVie Principal Scientist, DMPK in Sunnyvale, California
Principal Scientist, DMPK
Location: Sunnyvale, CA
# of Openings: 1
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
To learn more about us, please visit us athttp://www.pharmacyclics.com/
General Position Summary/Purpose:
The ideal candidate should have extensive experience supporting DMPK in drug discovery with a track-record of accomplishments in identifying clinical candidates for drug development programs, ideally in oncology indications. Responsible to provide pharmacokinetic and ADME expertise and strategy to support oncology discovery and early development projects.Influence cross functional teams to support preclinical development of drug candidate and regulatory submission.DMPK and PKPD lead in discovery project towards the selection of IND candidate(s).
Key Accountabilities/Core Job Responsibilities:
Represent DMPK in cross functional discovery and early development project teams to effectively identify and characterize high quality drug candidates towards the selection of IND candidate(s), determine drug liability, and plan for IND enabling studies.
Responsible for the design, real time data analysis, and interpretation of pharmacokinetic (PK), toxicokinetic (TK), and pharmacodynamic (PD) aspects of preclinical and clinical studies.
Review nonclinical data and use established guidelines to determine the starting dose for first in human studies. Provides a rationale for dose escalation and dose range in phase 1 studies.
Perform non-compartmental and compartmental, and pharmacokinetic-pharmacodynamic modeling of clinical and non-clinical data.
Write scientific reports and prepare appropriate documentation to support applications for regulatory agency filing. Provide DMPK and PKPD expertise and input into related documents such as Investigator Brochures, SOPs, study reports, manuscripts, summaries for regulatory authorities, INDs, NDAs and sNDAs.
Participate and present the results in group and project team meetings.
Champion on problem solving and addressing critical need and advancing project.
Must have clear and effective communication skills and building effective technical collaborations in a team model environment.
Qualifications and Requirements:
Ph.D. degree in pharmacokinetics, biopharmaceutics, pharmaceutical sciences, metabolism or related discipline. At least 8 years (PhD) relevant industrial experience in drug discovery setting with demonstrated impact on oncology drug discovery and/or development.
Appropriate modeling and computer software experience and proficient in computer programs or PK software, i.e., WinNonlin, NONMEM or similar programs.
Must have experience in delivering multiple small molecule compounds into IND and in early stage clinical development programs.
Ability to prioritize and manage multiple projects and activities while meeting tight deadlines
Proactive in problem-solving and be able to independently manage Proactive in problem-solving and be able to independently manage timelines and priorities.
Excellent interpersonal skills, strong written and oral communication skills.
Ability to work independently to drive project forward as well as collaboratively in a multidisciplinary team environment.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled