Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica®, Venclexta™, and Empliciti™ — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. 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. This position will be based at Stemcentrx, AbbVie's South San Francisco, CA location.
The Clinical Pharmacology and Pharmacometrics (CPPM) Organization leads the strategy, generation/analyses/interpretations/reporting of data and communications/agreements with global regulatory agencies in the areas of Clinical Pharmacology, Pharmacokinetics, Exposure-Response and Biopharmaceutics.
The organization supports all phases of pharmaceutical research and development from Discovery to Development to On Market Support for all new molecular entities and marketed products in all therapeutic areas (antiviral, immunoscience, neuroscience, pain, metabolic disease, men and women’s health, renal disease and oncology). The organization is responsible for defining the relationship between drug exposure (e.g., concentrations in blood) and efficacy measures (primary and/or secondary clinical outcomes or biomarkers) to select the optimal dose and dosing intervals. CPPM is also responsible for defining the relationship between drug exposure and safety measures (clinical outcomes or biomarkers (e.g., QTc)) to identify populations that may be at risk of increased toxicity or decreased tolerability. CPPM performs the selection, design and interpretation of all Phase I studies including first in human, bioavailability/ bioequivalence/food effect, drug interaction, pilot/
definitive cardiovascular (QTc), special population, pharmacogenetic and immunogenicity studies.
The organization provides critical support for conducting technical due diligence of new business opportunities (both in-licensing and out-licensing) by assessing probability of success for achieving Target Product Profile (TPP). CPPM contributes to responses to defend our intellectual properties and extension of patent protection, provides critical support for life-cycle management of marketed products, responds to questions from post-marketing safety, legal, pharmaceutical manufacturing and regulatory for marketed products world-wide, and publication of scientific information in patents and manuscripts.
We are seeking an experienced Pharmacokineticist to contribute to the success of an exciting oncology pipeline. The successful candidate will direct research and/or project activities and professional development of a group of scientists within the individual’s area of expertise by effectively mentoring, guiding and/or supervising scientific personnel. Independently conceive, execute and communicate novel multi-disciplinary research or development strategies that achieve project and area goals. Serve as a lead Pharmacokineticist on his/her own project and contribute scientific insights into multiple other projects.
* Effectively function as a principle investigator, generating original technical ideas and research or development strategies.
* Demonstrate creative & out of the box thinking to solve difficult problems and champion new technologies to achieve project goals.
* Independently responsible for project science within his/her area of expertise on one or more project teams.
* Make significant contributions to project team through lab based, or other work environments, activities.
* Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
* Recognized and sought out as an expert in his/her discipline within the company and possibly externally.
* Primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
* Present at leading scientific conferences.
* Mentor/supervise a team of one or more and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.
* BS or equivalent education and extensive, typically 12+ years of experience; MS or equivalent education with typically 10+ years of experience; PhD with typically 4+ years of experience Pharmacokinetics or Clinical Pharmacology
* Industry experience preferred. Oncology experience preferred. Other candidates encouraged to apply.
* Demonstrated ability to function as a lead Pharmacokineticist, generating original PK ideas to advance research or development strategies.
* Recognized and sought out as an expert in Pharmacokinetics within the company and possibly externally.
* Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
* Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences.
* Ability to effectively work with other research and development functions such as regulatory, toxicology, and In Vivo pharmacology.
Location/Region: South San Francisco