The opportunity
The holder of this position is expected to drive high quality of Clinical Pharmacology deliverables, lead change aimed at improving the efficiency of studies and to foster and implement innovative state-of-art methodologies in clinical pharmacology/early phase clinical research. By focusing on these areas the following achievements are expected: clinical timelines will be accelerated, cost of clinical studies will be reduced and entry into Phase-2/3 studies will be done with robust comprehensive data in healthy subjects and/or patients. To be successful the candidate must demonstrate strong leadership and collaboration within the group and with other GEC functions and R&D groups.
The Sr. Director spends most of her/his time doing independent technical work, leading tasks and supporting projects. The Sr. Dir CP can mentor 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. How you’ll spend your day
Travel Requirements: • Ability to travel with overnight stays, as required
Essential Duties & Responsibilities:
Sr.Dir CP is responsible for the CP/early clinical development deliverables for their programs teams:
Support the clinical pharmacology strategy across their specific programs
Generation of CP information and integration with up-to-date regulatory and scientific resources to inform decision-making and bring value to the programs.
Planning, direction, and interpretation of clinical pharmacology studies defined in the Clinical Development Plan
Participates in planning, writing and leading clinical pharmacology related modules of regulatory documents and application
Supports company clinical development strategy by:
Assessing impact of new and evolving relevant operational, scientific, and regulatory strategies and industry trends
Keeping abreast with relevant regulations and scientific literature.
Promotes the value of ClinPharm by sharing professional knowledge with external stakeholders
Developing consistent CP processes.
Responsible for financial planning/forecasting and budget management of their program.
Represents CP with internal and external stakeholders, and at relevant governances.
Initiates, develops, leads and participates in company initiatives to meet cross functional drug development objectives and other continuous improvement to achieve innovation in drug development, cost –reduction, time-savings, efficiency and quality business objectives.
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
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.
