Senior, Clinical Pharmacokineticist I
The Clinical Pharmacology and Pharmacometrics Organization (CPPM) 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 have an exciting opportunity for a Senior Clinical Pharmacokineticist I or II. Key Responsibilities Include:
PhD in field related to Pharmacokinetics
Demonstrates technical expertise on PK/PD projects
Must have demonstrated ability to lead PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion
Knowledge of standard business procedures (regulatory guidance, global regulations, SOPs)
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 the course quickly where indicated
Raises the bar and is never satisfied with the status quo
Creates a learning environment, opens to suggestions and experimentation for improvement
Embraces the ideas of others, nurtures innovation and manages innovation to reality
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
- Executes clinical Pharmacokinetics/Pharmacodynamics (PK/PD) research or development that achieves project and therapeutic area goals. Understands PK/PD regulatory advances, strengths, weaknesses, opportunities, and threats and assists with responses and appropriate new strategies.
- Acts as a lead Pharmacokineticist on one or more studies and investigates, identifies, develops, and optimizes new PK/PD models.
- Develops productive collaborations and communications with other groups, across multiple disciplines.
- Utilizes PK/PD expertise to provide PK/PD consultation to the business and leadership on decisions and development plans for multiple projects within a therapeutic area.
- Develop productive collaborations and communications with other groups across multiple disciplines.
- Writes, communicates, presents PK/PD materials.
- Contributes to the development of commercial and regulatory strategies by formulating PK/PD plans including development activities.
- Assists in the development of PK/PD plans to satisfy regulatory expectations and defend plans and interpretation of data to management.
- Integrates knowledge of all aspects of development from Discovery through Phase 4 (exposure, safety, efficacy, formulation, regulatory impact).
- Primary contributor to PK/PD interpretations of reports for regulatory filings and clinical protocols.
- Contributes to interpretation of study-related projects for external publications, project reviews, reports and/or regulatory submissions.
- Author in peer-reviewed journals, R&D reports, and/or regulatory documents/filings.
- May contribute to due diligence.