Allergan Exec Director Clinical Development CNS in New Jersey
Exec Director Clinical Development CNS
New Jersey, United States at https://agn.referrals.selectminds.com/jobs/6216/other-jobs-matching/location-only
Aug 06, 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.
Main Areas of Responsibilities
Responsible for ensuring the development and execution of the clinical strategy. This includes responsibility for the clinical team’s creation of relevant documents and outputs including Clinical Development Plan (CDP), clinical program feasibility, Investigator’s brochure, study protocol synopsis, clinical study protocols, top line study data communication plan, Clinical Study Report (CSR), clinical sections of regulatory documents including the clinical sections of the CTD for regulatory submissions, and planning of the Annual reports together with Regulatory affairs and respective clinical team members.
Ensures alignment of the CDP with the Global Development Plan (GDP). In addition, working collaboratively with the Program Operations Lead, the Clinical Lead oversees achievement of all activities related to the Clinical development program, including achievement of key program milestones within the planned time lines and budget. Is also accountable to the Project Core Team for the Clinical Development budget. Serves as the Submission team leader or co-leader for regulatory submissions.
Collaborates with the core project team members and departments (RA, Biostat’s, Safety, HEOR etc), the incumbent leads the synthesis of the project development strategy, contingency plans, tactics, budgets, timelines, milestones and submission targets into the Global Development Plan (GDP).
S/he is accountable for securing Senior Management approval to the project strategy including timelines and budgets, as well as the execution of the plan through leveraging the Global Development organization and other Allergan functions (e.g. Regulatory Affairs, Global Health Outcomes). The Global Project Leader is accountable to manage the project through the development stage gates, and to lead the Project Core Team to reach decisions and recommendation at each stage gate, including revisions to the development plan, timelines and budget if indicated. Moreover, she/he has the overall responsibility for delivering the project’s regulatory submissions objectives.
Responsible for adherence to all relevant regulations eg: ICH, PhRMA and CFR guidelines, as well as Allergan’s policies, SOPs and Work Instructions. Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks. Provide strategic and/or technical consultations on behalf of the therapeutic area (eg, study design, business development, marketing, communications, training, legal, etc.). Support and oversight of epidemiological studies as needed.
CNS/Psych./Migraine/Pain/ Clinical Development experience required.
Min. 10 years relevant clinical/drug development experience including experience working in clinical research with a strong understanding of the clinical and global drug development process.
5+ years’ experience as a cross-functional team leader preferred
Ability to travel up to 30% of time
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.