Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
As defined in the scope of the assigned development project(s), the Director, Clinical Development NASH (Nonalcoholic steatohepatitis) may have global or regional responsibilities and fulfil the following roles:
The Director, Clinical Development NASH should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members.
Main Areas of Responsibilities
Responsible and accountable for the development, implementation and delivery of the global clinical development strategy for a given project within time, budget and with high quality. He/she leads the development of the Clinical Development Plan in collaboration with the Clinical Science Lead and members of the Clinical Sub-Team, ensuring alignment with the agreed Global Development Strategy.
Responsible and accountable for the scientific validity and integrity of the Clinical Development Plan and all clinical content, including, but not limited to: protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions and publications associated with the clinical trials. In collaboration with the CPL and Clinical Sub-team members, the CSL participates in the development of the Clinical Development Plan by contributing the scientific/clinical expertise for the strategy. Once completed, the CSL is responsible for and leads the scientific/clinical aspects of the execution of the defined Clinical Development Plan.
Representing Clinical Development as a core team member on the Clinical Trial Team
Providing a clinical review of study-specific documentation and training materials
Performing clinical data reviews
Assessing reported protocol deviations
Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial
Minimum 10 years of overall work experience or equivalent combination of experience and education
Minimum 5 years of clinical/research experience in the pharmaceutical/device industry preferred
Ability to travel up to at least 20% of time, this may international travel
Understands & leverages cross-functional roles & responsibilities to effectively & efficiently accomplish team goals
Takes initiative to contribute clinically relevant scientific ideas and knowledge to team globally
Actively seeks to understand other perspectives
Articulates business impact
Meets corporate timelines
Ability to make tough decisions quickly
MD, PharmD, PhD in life science required.
Knowledge and experience in the relevant or related Therapeutic Area preferred (Hepatology, Infectious Disease, Metabolic, Endo.)