Senior Scientist II, QTAS Biologics Project Representative

Purpose

Conceive and execute novel scientific research or development that achieves projects and area goals. Generate new scientific proposals and lead those efforts. Investigate identify develop and optimize new methods and techniques. Act as a lead scientist in his/her area of expertise and critically evaluate relevant scientific and regulatory advances and integrate this knowledge into research or development programs.

The Quantitative Translational and ADME Sciences (QTAS) group is searching for an experienced project representative to provide biologics project support across all therapeutic areas for molecules in discovery and clinical development. The position requires close collaboration with Discovery and Development project teams clinical pharmacology and other stakeholders developing and executing QTAS and PK/PD strategies necessary to facilitate the advancement of our pipeline.

Responsibilities

• Serve as a QTAS representative on project teams supporting the development of novel biologics; collaborate with project team members (e.g. clinical pharmacology protein analytics discovery toxicology) and groups within QTAS to generate relevant data guiding target validation biomarker selection and candidate selection
• Develop and drive the QTAS and PK/PD strategy for large molecule discovery preclinical and clinical development projects to support decisions and milestone transitions
• Effectively communicate QTAS and PK/PD strategy and knowledge to project teams functional leaders and other key stakeholders to ensure alignment and influence decisions
• Demonstrate thorough understanding of the PK/PD and bioanalytical aspects necessary for the selection and characterization of antibodies including considerations for bispecific antibodies antibody-drug conjugates and novel modalities
• Coordinate and request PK PK/PD and bioanalytical studies in a timely manner and communicate protocols timelines needs and results back to team ensuring optimized cycle times
• Conduct value-added PK/PD-related quantitative analyses to support project team or project strategy decision-making
• Serve as a liaison with bioanalytical groups to ensure timely reagent generation method development and sample analysis
• Prepare QTAS sections of regulatory documents (IB IND BLA); provide responses to regulatory questions and ensure generation of appropriate reports

*Level and compensation will be commensurate with experience

Qualifications :

• Bachelors Degree or equivalent education with 12 years of experience or Masters Degree or equivalent education with 10 years of experience or PhD with 4 years of experience within the pharmaceutical or biotechnology industries.
• Experience independently representing QTAS on biologics project teams is required (expertise with novel modalities is preferred)
• Expertise with PK analysis of biologics and relevant data analysis software such as Phoenix/WinNonlin
• Familiarity with modeling software such as MATLAB/SimBiology R Python or Berkeley Madonna is desired
• Understanding of biologics PK/PD modeling and analytical assays for measuring biologic molecules and biomarkers (including ligand binding and mass spectrometry assays) in preclinical study samples is desired
• Demonstrated scientific leadership including generating original scientific investigative strategies and guiding those efforts to an effective and productive outcome
• Recognized expert in his/her discipline
• Demonstrated publication or patent record; lead/senior author contributions a plus
• Ability to influence negotiate and communicate effectively with both internal and external stakeholders; ability to work well in a collaborative fast-paced team environment
• Highly motivated self-driven and results-oriented with excellent communication and presentation skills; capable of working both as team player and project driver
• High degree of flexibility in adapting to different projects and people; excellent networking and relationship-building (both internal and external) skills
• Passion for data analysis solving technical problems and applying new technologies to further scientific goals

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

• This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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