Allergan Associate Director, Clinical Development NASH in San Francisco, California
Associate Director, Clinical Development NASH
San Francisco, California, United States at https://agn.referrals.selectminds.com/jobs/5968/other-jobs-matching/location-only
Jul 11, 2018Post Date
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 Associate Director, Clinical Development may have global or regional responsibilities and fulfil the following roles in support of studies within NASH (Nonalcoholic steatohepatitis)
Core Team Lead (CTL)
Clinical Program Lead (CPL)
Clinical Science Lead (CSL)
Clinical Scientist (CS)
The Associate 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.
The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.
Ensuring alignment between the Governance Board, Core Team and Sub-teams
Developing the project milestones with the Core team and seeking endorsement from the Governance Board on the Global Development Strategy, Stage Gates and other decisions requiring Governance Board endorsement
Guiding the project through the defined Stage Gates
Analyzing, managing project risks and proposing solutions for risk mitigation
Resolving project/functional conflicts
Managing, together with the Project Manager, the project budget and timelines
With the Project Manager and core project team members from Commercial, managing the valuation of the project
Communicating any potential risks to the Governance Board co-chairs and any relevant line functions in a timely manner
If applicable, managing external partnerships and ensuring alignment and preparation for Joint Development Committee (JDC) meetings
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.
The CTL may present the project, including clinical development aspects and results, at internal or external meetings (e.g., with Regulatory Authorities, with external experts).
Main Areas of Responsibilities
Working closely with various departments, increasingly in a consultancy role, assisting line managers to understand and implement policies and procedures;
Liaising with a wide range of people involved in policy areas such as staff performance and health and safety;
Developing and implementing policies on issues like working conditions, performance management, equal opportunities, disciplinary procedures and absence management;
Negotiating with staff and their representatives (for example, trade union officials) on issues relating to pay and conditions;
Uses facts and data to validate own position
Ability to make connections between organization, team, product, ideas, etc.
Ability to understand implications of strategic decisions
Delegates to team and keeps them focused, as applicable
Demonstrates basic understanding of global pharmaceutical/ device product development environment
Minimum 7 years of overall work experience or equivalent combination of experience and education
Minimum 5 years of clinical/research experience in the pharmaceutical industry preferred
Ability to travel up to at least 30% of time, may include 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
MD, PharmD, PhD in life science required knowledge and experience in the relevant or related Therapeutic Area preferred (Hepatology, Infectious Disease, Metabolic, Endo.)
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.