Senior Clinical Pharmacokineticist
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 definingthe relationship between drug exposure and safety measures (clinical outcomesor biomarkers (e.g., QTc)) to identify populations that may be at risk ofincreased 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 (bothin-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. Key Responsibilities Include:
For Senior Clinical Pharmacokineticist II
- Provides clinical pharmacology support for marketed products andproducts in development.
- Provides scientific assessments on drug-drug interactions or the relevant clinical pharmacology issues to meet internal customer needs andregulatory commitments on these products.
- Provides clinical pharmacology support of multiple marketed products to meet cross-functional customer needs.
- Critically evaluates literature and in-house clinical pharmacology data including drug interaction information, interprets complex data, and presents clinical pharmacology information to internal customers
- Provides clinical pharmacology sections related to drug-drug interactions or basic pharmacokinetic principles and regulatory responses based on internal customer needs and to fulfill regulatory requirements
- Communicates clinical pharmacology data interpretations clearly and succinctly both verbally and in writing to cross-divisional functional areas
- Maintains in-depth understanding of product knowledge, labeling, and relevant data for assigned products
- Acts as a subject matter expert to internal customers to provide scientific and clinical pharmacology information to make the relevant decisions
- Assumes independent responsibility for workload and projects as assigned
- Represents department as functional expert at cross-functional team meetings
- Prioritizes multiple activities to accomplish internal customer and regulatory needs
- Other pharmacy- or clinical pharmacology related activities per manager's assignment
For Senior Clinical Pharmacokineticist II
- Pharm. D. degree required.
- At least 2 years Post-PharmD training such as fellowship, residency and/or clinical pharmacy experience required.
- Basic understanding of clinical pharmacokinetics, with advanced knowledge in drug-drug interactions and relationship of drug concentrations to safety and efficacy.
- Pharm D. Degree required
- Basic understanding of clinical pharmacokineticist with advance knowledge in a drug-drug interactions and relationship of drug concentrations to safety and efficacy.
- Builds strong relationships with cross-functional teams to enable higher performance
- Learns fast, grasps the 'essence' and can change the course quickly where indicated
- Creates a learning environment, opens to suggestions andexperimentation for improvement
- Embraces the ideas of others, nurtures innovation and managesinnovation to reality