Principal Research Scientist I/II - QTAS Senior Biologics Project Representative & Modeler

Location

South San Francisco, CA | United States

Job description

AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company with a mission to develop innovative therapies to address the world's most complex and serious diseases. AbbVie employs approximately 47,000 people worldwide and markets medicines in more than 175 countries.

Description

The AbbVie portfolio consists of several marketed products in areas including eye care, immunology, oncology, virology, and women’s health as well as a pipeline containing multiple promising new molecules being studied in hundreds of clinical trials or advancing from Discovery into Development. AbbVie is a global organization with US research sites in Boston (Worcester, MA), Chicago (North Chicago, IL), and the San Francisco Bay Area (South San Francisco, CA). The biologics portfolio is comprised of diverse and tailored modalities including mono- and bispecific antibodies, antibody-drug conjugates, dual variable domain antibodies, antibody fragments, and other recombinant proteins as well as cell-based and gene therapies.

The Quantitative, Translational & ADME Sciences (QTAS) group is searching for a senior contributor with extensive experience as a 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 our pipeline.

Key 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, safety) 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, senior management, 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 bispecific antibodies and antibody-drug conjugates.
• 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 DMPK-BA sections of regulatory documents (IB, IND, BLA); provide responses to regulatory questions and ensure generation of appropriate reports

Qualifications:

• Bachelor’s degree with extensive experience (14+ years), master’s degree with substantial experience (12+ years), or doctoral degree (Ph.D., Sc.D., Pharm.D.) with at least 6 years of experience in 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 or R is required.
• Expertise in mechanistic and translational PK/PD modeling and competency with relevant tools such as MATLAB/SimBiology, R, Python, or Berkeley Madonna is strongly preferred.
• Detailed understanding of bioanalytical methods for measuring proteins (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 the field with examples of external visibility.
• Demonstrated publication or patent record; lead/senior author contributions preferred.
• Ability to influence, negotiate and communicate effectively with both internal and external stakeholders; a bility 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.

Key Leadership Competencies :

• Builds strong relationships with peers and cross-functionally with partners outside of team to enable higher performance.
• Learns fast, grasps the "essence" and can change course quickly when necessary.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.

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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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