Sr Clinical Pharmacology Scientist
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The Clinical Pharmacology organization at AbbVie, leads the strategy, generation, analyses, interpretations, and reporting of data and communications/agreements with global regulatory agencies in the areas of Clinical Pharmacology, Pharmacokinetics (clinical and nonclinical), Exposure-Response, Immunogenicity, 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 across multiple therapeutic areas.
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 or safety measures (clinical outcomes or biomarkers (e.g., QTc)) to identify populations that may be at risk of increased toxicity or decreased tolerability.
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 the Target Product Profile (TPP). It also 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.
The Clinical Pharmacology group, as part of Research, Nonclinical and Translational Sciences (RNTS) at AbbVie, is seeking a Senior Scientist – Clinical Pharmacology. As a member of multidisciplinary teams, this individual will be responsible for the strategy, conduct, data analyses, interpretation, and reporting of clinical pharmacology studies and nonclinical and clinical pharmacokinetic studies. In addition, the individual will also be responsible for strategy, data analyses, interpretation, and reporting of biomarker and immunogenicity studies. A key business deliverable will be the characterization the relationship(s) between exposure (drug, antibody, biomarker) and response (pharmacodynamic, toxicodynamic) for both desired and undesired effects. The individual should be comfortable with studies beyond systemic drug development including ophthalmology, neurotoxin, and aesthetics/dermatology. This individual will play a key role as a clinical pharmacology representative on clinical subteams and as PK representative on nonclinical and translational subteams and may act as a Clinical Pharmacology subject matter expert on behalf of AbbVie to external parties (including external collaborations and diligence assignments). The right candidate should be proactive, inquisitive, a self-starter who is eager to learn and thrives in a fast pace and independent environment, with a desire to interact as a clinical pharmacology and pharmacokinetics expert with matrix project teams.
Specific responsibilities include:
- Propose clinical pharmacology, pharmacokinetic, biomarkers and immunogenicity strategy for projects at various stages in discovery and development.
- Design and scientific oversight of clinical pharmacology and nonclinical pharmacokinetic studies.
- Participate in decision for dose recommendations for first-in-man single-dose and multiple-dose tolerability studies
- Provide input to late stage development clinical protocols and study reports which include PK, biomarker, pharmacogenetics, and/or immunogenicity evaluations.
- Analyze, interpret and report PK, PD, and immunogenicity datasets.
- Represent clinical pharmacology on project teams.
- Author preclinical pharmacokinetics, clinical pharmacology, biopharmaceutics sections and contribute to efficacy and safety sections for world wide regulatory submissions
- Provide subject matter expertise on behalf of AbbVie for external collaborations and due diligence assignments.
- Ensure that clinical trials are conducted according to GCP/ICH guidelines, FDA regulations, and AbbVie’s standard operating procedures .
- Ph.D. or PharmD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences or related field and 2 – 5 years of pharmaceutical industrial experience.
- Other important skills could include expertise in non-clinical pharmacokinetics, pharmacodynamics, ADME, and a good understanding of immunogenicity, biomarkers or pharmacogenomic analyses.
- Effective written and verbal communication skills required. Excellent collaboration and team skills are required. Experience interacting with the various clinical functions in an organization in a plus.
- The successful candidate is required to have a good understanding of regulatory environment to support regulatory and corporate agencies.
- Strong scientific and leadership skills with the ability to lead research and development sub-teams and influence and collaborate with leaders in R&D is required.
- Ability to utilize PK/PD data analysis and modeling/simulation software (NONMEM, SAS, etc.) is a plus.
- Active scientific participation and collaboration with colleagues in industry, academia and regulatory agencies. Scientific publications in area of specialization are a plus.
- The successful candidate is required to have ability to work within a diverse workforce.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.