Allergan Executive Director, Clinical Development Infectious Disease in Jersey City, New Jersey
Executive Director, Clinical Development Infectious Disease
Jersey City, New Jersey, United States at http://agn.referrals.selectminds.com/jobs/156/other-jobs-matching/location-only
Jul 28, 2016Post 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 pharmaceuticals and biologic products for patients around the world. Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular 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. Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
The Exec. Director is responsible for providing scientific and clinical development direction and guidance at the product, project and study level within the Infectious Disease therapeutic area. Several accountabilities must be fulfilled by the Exec. Director, ID.
As the Clinical Lead, she/he is the Clinical representative on the Global Project Core Team and leader of the cross-functional Clinical subteam. S/he is overall accountable for the development and execution of the global clinical development plan, working in collaboration with the members of the Clinical subteam.
As the Clinical Scientist, she/he is a member of the Clinical subteam and has responsibility for providing scientific and clinical development guidance and expertise at the global product and project level and, at the clinical subteam and study level.
The Exec. Director, ID may also perform the role of Global Project Team Lead where s/he is responsible for the leadership of a cross-functional global project development team on one or more projects.
The Exec. Director, ID represents R&D at regulatory agency meetings, symposia and trade associations and aims to establish and maintain a strong network within the Pharmaceutical industry.
Main Areas of Responsibilities
Responsible for leading the development and execution of the clinical strategy. This includes responsibility for the clinical team’s creation of relevant documents and outputs including the 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.
Delegates alignment of the CDP with the Global Development Plan (GDP). In addition, working collaboratively with the Program Operations Lead, the Exec. Dir., ID monitors 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 first line of accountability to the Project Core Team for the Clinical Development budget. Serves as Submission team 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 attaining 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 will 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, s/he has first line responsibility for delivering the project’s regulatory submissions objectives.
Responsible for advising and enforcing 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.
Infectious Disease Clinical Development experience required.
Min. 15 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