The opportunity
The Director of Clinical Pharmacology (Dir CP) has overall responsibility for clinical pharmacology strategy of assigned projects; ultimately ensuring maximal alignment of relevant aspects of the label with the TPP. The Dir CP ensures generation and continuous integration of all available clinical pharmacology (PK, PD, PK/PD) information with up-to-date regulatory and scientific resources to inform decision-making and bring value to the projects. The Dir CP is responsible for the planning, direction/execution, and interpretation of clinical pharmacology studies in accordance with Teva strategy and priorities, leading the cross-functional study team. The role includes, but is not limited to, interaction with pharmacometricians, clinical pharmacology trial managers and clinical/project team members and any other relevant matters for this role.
The Director spends most of her/his time doing independent technical work, leading tasks and supporting projects. The Dir CP can supervise junior team member, he/she can lead multiple projects, often will serve as a clinical lead as part of the Clinical Development Team (CDT) and being an expert in CP contributes to the overall quantitative clinical pharmacology strategy and other cross functional/department initiatives as necessary.
Travel Requirements: • Ability to travel with overnight stays, as required
This position is a hybrid role based out of our West Chester, PA office. Candidates within commuting distance to our Parsippany, NJ office will also be considered.How you’ll spend your day
Supports the entire portfolio of Teva Specialty programs/products across multiple therapeutic areas and all phases of clinical development from a clinical pharmacology perspective (from first in man through post-approval), translating relevant Target Product Profile (TPP) attributes into clinical studies/evaluations required to achieve the target label.
Ensures the generation and continuous integration of all available clinical pharmacology-related information (clinical PK, PD, PK/PD) with up-to-date regulatory and scientific resources to inform decision-making, proactively identifying risks, and ensuring decisions are made at the appropriate levels and with the appropriate cross-functional input.
Lead the CP strategy, planning, direction, execution and data interpretation of CP studies (e.g. Phase 1a, 1b, special populations, device bridging, ethnic bridging, DDIs) with scientific rigor and innovative approaches.
Accountable for the planning, direction, and interpretation of clinical pharmacology studies designed to investigate the safety/tolerability, PK and PD of the compound/product:
Leads design of, and participates in protocol and clinical study report writing, taking full accountability for clinical pharmacology/Phase 1 studies
As a clinical leader of the study, Dir CP implements relevant assessments to facilitate further clinical development and increase probability of success
Together with the Trial Manager, ensures that clinical pharmacology studies are run in accordance with set budget and timelines and in accordance of relevant SOPs
Responsible for the analysis and interpretation of PK results generated in the study, in collaboration with other functions
Leads presentation of study design and results to internal and external governance bodies
Works in matrix with pharmacometrics colleagues to define first in human dose range and characterize exposure-response relationships to guide drug development
Integrates preclinical information to progress molecules from nomination to early clinical development stages
Support all clinical pharmacology related aspects of late stage clinical studies.
Participates in planning, writing and leading clinical pharmacology related modules of regulatory documents and applications
Represents clinical pharmacology and defend clinical pharmacology strategy and study results and interpretation at regulatory interactions.
Follows Teva Safety, Health, and Environmental policies and procedures
