Clinical Pharmacologist Jobs

Contributes to clinical pharmacology plans and summary documents including drug-drug interaction, special population and safety studies.

In collaboration with clinical pharmacometricians, you will represent Clinical Pharmacology and Quantitative Pharmacology in cross-functional project teams, and take responsibility for developing the...

Develop model-based justifications for optimal doses selected for pivotal clinical trials, while working in close partnership with clinical Development and statisticians...

Is responsible for the preparation and timely delivery of accurate study reports was well as regulatory submission documents as appropriate.

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)...

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...

Proficient in integrating model-informed drug development approach to enhance program team decisions.

Work in close collaboration with biologists, clinicians, precision medicine scientists, clinical pharmacologists, pharmacometricians, QSP and nonclinical modelers, and other partner line colleagues to...

• Interface with other functional area representatives (clinical pharmacologists, toxicologists, translational medicine representative, clinical scientists) to deliver on program goals...

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...

Develop model-based justifications for optimal doses selected for pivotal trials, while working closely in a matrix environment with clinical development, statistics and operations...

Work in close partnership with Clinical Operations, Biostats, Programming, Data management, Clinical Sciences, Medical and Translational Research teams...

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...

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...

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...

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...

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...

Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession

Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication

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...

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...

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...

Demonstrates an analytical mindset and is skilled at analyzing complex information to arrive at reasonable conclusions.

This role will review external data, lead the analysis, interpretation and reporting of clinical pharmacokinetic data

Representation for clinical pharmacology on at a program level and oversee all study-related activities .