Senior Scientist, PK - PDL BioPharma

Position Description

Leave your mark at PDL BioPharma, Inc.

PDL BioPharma, Inc is a biopharmaceutical company focused on the discovery and development of novel antibodies in oncology and select immunologic diseases. Our current product pipeline includes four breakthrough therapies. Pioneering science and a rich development pipeline define PDL BioPharma. And our success is based on one key factor – our people. At PDL BioPharma, every employee directly contributes to the development and delivery of innovative therapies that help make real a difference in people’s lives. We foster a goal-oriented and entrepreneurial culture where teamwork, commitment, and initiative are valued and rewarded. PDL BioPharma invites you to be part of the future of biotechnology. We are proud to be an equal opportunity employer.

Senior Scientist, PK

This position is responsible for the PK-PD assessment aspect of development programs involving both clinical and preclinical studies. Principal duties and responsibilities include but not limited to:
• Representing PK functional area on project development teams, familiar with regulatory guidlines and lead the strategic recommendations in PK-PD assessment aspect of the development program.
• Performing (or overseeing CRO to perform) pharmacokinetic/pharmacodynamic evaluation/data analyses for clinical studies (Phase I through III), responsible for data interpretation and preparation of final analysis reports.
• Participating in designing clinical study protocols and choice of methods to evaluate data: developing pharmacokinetic/ pharmacodynamic models to predict drug kinetics and PK/PD relationships using population analysis approach; providing dose simulations or conducting clinical trial simulations to recommend clinical study dosing strategies, assessing exposure/response relationships in facilitating the identification of clinical optimal dose levels and providing exposure/effect rationale for the dose selection of the pivital trials.
• Integrating PK and immunogenicity outcomes to facilitate the assessment of related safety issues, correlating the pharmacokinetics data with other pharmacodynamic endpoints and assist in identification of relevant PD markers.
• Developing, writing and preparing data summary for publications, regulatory submissions and technical reports; working independently to achieve departmental and company objectives.
• Presenting findings at internal company meetings and as appropriate, at external conferences; maintaining broad knowledge of state-of-the art principles and theories by staying current with scientific literature and attending scientific meetings
• Responsible for TK/PK strategies and assessment for non-clinical programs (including Toxicity studies, PK/PD studies, bioequivalent studies and pharmacology studies).

Requirements:
MD or Ph.D in Pharmacology, pharmacokinetics, pharmaceutical sciences, or equivalent with minimum 5-7 years industry experience in clinical PK/PD analysis and drug development; a good knowledge and or hands on experience with WinNonlin, NONMEM, and S-plus programs; expertise in preclinical/clinical pharmacokinetic study design and analysis as well as with PK/PD modeling for proteins/antibodies/biologics; familiar with GLP/GCP regulations, strong written and verbal communication skills and the ability to communicate across functional areas; strong skills in prioritizing tasks and handling multiple programs simultaneously; must demonstrate positive interpersonal, conflict resolution and problem solving skills.

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