Allergan Assoc Dir, Study Start Up Management in Madison, New Jersey
Assoc Dir, Study Start Up Management
Madison, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/7403/other-jobs-matching/location-only
▾ ▸ 1 additional location
Dec 03, 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.
The Associate Director, Global Lead, Strategic Start Up is responsible for overseeing global, cross-functional start-up activities for their assigned Therapeutic Area(s). In addition, the role is responsible for operational oversight of the start up team to ensure activities and tasks are performed appropriately and in compliance with all Allergan policies and procedures
Other activities, special projects and assignments may be given as required. As a result, the percentage of time spent across the roles for which the employee is responsible will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
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.
Main Areas of Responsibilities
Start Up Strategy
· Advise and support teams in the development of the overall start up strategy, risk assessment, and contingency planning at a study, program and TA level.
· Assist teams with start-up strategy implementation and change management.
· Partner with key stakeholders to support start up milestones and KPIs, with a focus on critical path activities.
· Harmonize Start Up Tracking and provide Executive Level Start Up Metrics
· Identify opportunities for increased efficiency and/or cost savings by achieving consistencies across studies, programs and TAs.
· Provide leadership, support, and influence to ensure timely and quality start up deliverables.
· Provide leadership to Start Up Team in metrics development and implementation.
· Maintain operational oversight of assigned Study Start Up Specialists in all aspects of the Start Up Essential Document activities and CTA deliverables
· Responsible for implementation of quality, efficient, and consistent approaches to carrying out tasks. Delivering training to departments, as necessary. Identifying opportunities for improvement and efficiency, and assisting with defining and implementing solutions.
Subject Matter Expert
· The Associate Director, Global Lead, Strategic Study Start Up is expected to be a subject matter expert Study Start Up requirements, activities and best practices, from the time of protocol concept through site activation
· A degree in a science or health-related discipline is preferred, and significant clinical experience with emphasis on study start up strategy is mandatory
· Advanced understanding of Good Clinical Practices, ICH guidelines, PhRMA code, clinical research ethics, and patient privacy laws (plus applicable local regulations, when country-based).
· Ability to travel up to 30% of the time
· Excellent computer skills (Word, Excel, and PowerPoint), excellent interpersonal skills, ability to work effectively independently and with a team, and ability to influence and lead by example.
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.