Allergan Sr. Director, Clinical Development Infectious Disease in Jersey City, New Jersey
Sr. Director, Clinical Development Infectious Disease
Jersey City, New Jersey, United States at http://agn.referrals.selectminds.com/jobs/157/other-jobs-matching/location-only
Jul 28, 2016Post Date
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 Sr. Director Clinical Development, Infectious Disease is the internal scientific expert in the disease area and scientific aspects of the competitive landscape. The incumbent is accountable for ensuring the medical/scientific expertise, validity and integrity of the clinical development program and study protocols, clinical study reports and clinical submission documents.
This individual will play a key role in supporting clinical study planning and execution through the development lifecycle starting with the creation of the Clinical Development Plan (CDP) and clinical study protocol synopsis, input into the clinical study protocol and Clinical Study Report and Clinical sections of the CTD for regulatory submissions, while working collaboratively with the cross-functional Clinical Team to assess study data, integrate summaries of safety and efficacy, risk / benefit assessments, etc. This information is incorporated into Agency briefing packages, Investigator Brochures, and regulatory documents, including the clinical modules for submissions. The Sr. Director will function as Clinical Scientist and may also serve as a Submission team leader or co-leader for regulatory submissions. In addition, the incumbent is the key contact for relationships to external experts/ Key opinion leaders and provides regular scientific-medical disease state updates, etc.
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.
Infectious Disease 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