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Contributes to clinical pharmacology plans and summary documents including drug-drug interaction, special population and safety studies.
Posted 1w ago
• 11 - 15 years exp. • Pharmaceuticals & Biotech
In collaboration with clinical pharmacometricians, you will represent Clinical Pharmacology and Quantitative Pharmacology in cross-functional project teams, and take responsibility for developing the...
Posted 2w ago
• Pharmaceuticals & Biotech
Develop model-based justifications for optimal doses selected for pivotal clinical trials, while working in close partnership with clinical Development and statisticians...
Posted more than 4w ago
• Less than 5 years exp. • Pharmaceuticals & Biotech
Is responsible for the preparation and timely delivery of accurate study reports was well as regulatory submission documents as appropriate.
Posted more than 4w ago
• Pharmaceuticals & Biotech
The Senior Manager of CP may represent the CP department at internal (study, project, clinical team) and external meetings (with regulatory authorities, collaborators, and/or vendors)...
Posted more than 4w ago
• Less than 5 years exp. • Pharmaceuticals & Biotech
The candidate is expected to be an active contributor to the multi-disciplinary project teams, providing innovative and progressive thinking to projects and where appropriate guidance to other team me...
Posted more than 4w ago
• 5 - 7 years exp. • Pharmaceuticals & Biotech
Proficient in integrating model-informed drug development approach to enhance program team decisions.
Posted more than 4w ago
• 8 - 10 years exp. • Pharmaceuticals & Biotech
Work in close collaboration with biologists, clinicians, precision medicine scientists, clinical pharmacologists, pharmacometricians, QSP and nonclinical modelers, and other partner line colleagues to...
Posted 2d ago
• Less than 5 years exp. • Pharmaceuticals & Biotech
• Interface with other functional area representatives (clinical pharmacologists, toxicologists, translational medicine representative, clinical scientists) to deliver on program goals...
Posted 2w ago
• Less than 5 years exp. • Pharmaceuticals & Biotech
Conducts the analysis, interpretation and reporting of clinical and non-clinical pharmacokinetic data. Helps plan, conducts and reports quantitative analyses to select / optimize doses, dosage regime...
Posted more than 4w ago
• 5 - 7 years exp. • Pharmaceuticals & Biotech
Develop model-based justifications for optimal doses selected for pivotal trials, while working closely in a matrix environment with clinical development, statistics and operations...
Posted 2w ago
• 8 - 10 years exp. • Finance & Insurance
Work in close partnership with Clinical Operations, Biostats, Programming, Data management, Clinical Sciences, Medical and Translational Research teams...
Posted 2w ago
• 8 - 10 years exp. • Pharmaceuticals & Biotech
The clinical pharmacology lead will be an integral member of the multidisciplinary team and is responsible for leading the clinical pharmacology support to Turning Point Therapeutics transformative on...
Posted 3w ago
• Less than 5 years exp. • Pharmaceuticals & Biotech
Lead all data management aspects of a clinical study with minimal oversight, including study start-up activities, and guide the study team through change orders and protocol amendments...
Posted 2d ago
• Less than 5 years exp. • Healthcare
Provides leadership in biometrics activities pertaining to study projects. Collaborates with project teams on design and analysis of clinical trials; selects appropriate statistical methods for design...
Posted 1w ago
• 8 - 10 years exp. • Pharmaceuticals & Biotech
Providing scientific leadership on strategy and translational science to cross-functional project teams. Working with clinical development program teams to achieve program goals and provide deliverabl...
Posted 2w ago
• 8 - 10 years exp. • Pharmaceuticals & Biotech
Be subject matter expert for safety relevant discussions with regulatory agencies and other significant external bodies Participate and provide clinical and safety input into regulatory interaction...
Posted 1w ago
• 11 - 15 years exp. • Pharmaceuticals & Biotech
Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession
Posted 2w ago
• Less than 5 years exp. • Healthcare
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
Posted 1w ago
• 11 - 15 years exp. • Pharmaceuticals & Biotech
Implement optimal dose-finding strategies to ensure safe and effective advancement of clinical programs. Design clinical drug-drug interaction and food effect studies following regulatory guidance...
Posted 3w ago
• 11 - 15 years exp. • Pharmaceuticals & Biotech
Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for dose escalation meetings a...
Posted 3w ago
• 5 - 7 years exp. • Pharmaceuticals & Biotech
Lead the resolution of clinical pharmacology queries from drug regulatory agencies, taking a lead role in writing and reviewing responses to clinical pharmacology regulatory queries. Ensure/perform ap...
Posted 3w ago
• 11 - 15 years exp. • Pharmaceuticals & Biotech
Demonstrates an analytical mindset and is skilled at analyzing complex information to arrive at reasonable conclusions.
Posted 3w ago
• 11 - 15 years exp. • Pharmaceuticals & Biotech
This role will review external data, lead the analysis, interpretation and reporting of clinical pharmacokinetic data
Posted more than 4w ago
• 11 - 15 years exp. • Healthcare
Representation for clinical pharmacology on at a program level and oversee all study-related activities .
Posted more than 4w ago
• 8 - 10 years exp. • Pharmaceuticals & Biotech