Allergan Director, Clinical Development CNS in Irvine, California
Director, Clinical Development CNS
Irvine, California, United States at http://agn.referrals.selectminds.com/jobs/615/other-jobs-matching/location-only
Sep 23, 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.
Oursuccess 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.
Joinour bold team! Learn more at www.Allergan.com
The Director is responsible for providing clinical development direction and guidance at the project and study level. Several roles can be fulfilled by the Director.
As the Clinical Lead, s/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, s/he is a member of the Clinical subteam and has responsibility for providing scientific and clinical development guidance and expertise at the global product, project, clinical subteam and study level.
The Director, with the adequate level of experience and moderate oversight, 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 Director assists in the preparation for and may represent R&D at, regulatory agency meetings, symposia and trade associations and aims to establish and maintain a strong network within the Pharmaceutical industry.
The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as necessary. As a result the percentage of time spent across the roles for which the employee is responsible or accountable will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
The employee must conduct his/her work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Main Areas of Responsibilities
The incumbent is the internal scientific expert in the disease area and scientific aspects of the competitive landscape. The Clinical Scientist 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.
S/he plays a key role in supporting clinical study planning and execution through the development 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 Clinical Scientist 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.
The incumbent is responsible for the leadership and the results of the clinical team throughout the Global Clinical Development process. The Clinical Lead represents the clinical team in the core project team.
The incumbent has overall responsibility 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. S/he 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. The Clinical Lead is accountable to the Project Core Team for the Clinical Development budget.
The Clinical Lead may also serve as a Submission team leader or co-leader for regulatory submissions.
The Incumbent is responsible for the leadership and results of a cross functional global project development team throughout the Global Development process.
In collaboration with the core project team members and the departments involved, 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, s/he has the overall responsibility for delivering the project’s regulatory submissions objectives.
Based on the agreed GDP, and in collaboration with Project Management and the core project team, the Global Project Lead sets development milestones and budget targets for the core team which are also cascaded to all related sub-teams to ensure that goals are aligned and budgets are met. The Global Project Lead will set the core team member’s project goals and is responsible for conducting their performance evaluation with the aspects of these goals.
The Global Project Leader will provide oversight of the evolution of the project’s Risk Management plan through all stages of Development.
The Global Project Leader may also lead Agency interactions in partnership with the TA Head and Regulatory Affairs.
The incumbent is 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. Support and oversight of epidemiological studies as needed. May provide strategic and/or technical consultations on behalf of the therapeutic area (eg, study design, business development, marketing, communications, training, legal, etc.).
· Therapeutic Area experience strongly preferred
· 5+ years relevant clinical/drug development experience including experience of working in clinical research with a strong understanding of the clinical and global drug development process.
· 3+ years’ experience as a cross-functional team leader preferred
· Ability to travel up to 30% of time
o Takes initiative to contribute ideas and knowledge to team globally
o Participates in team activities
o Actively listens
o Adapts to change in team strategy
· Influential Communication
o Uses facts and data to validate own position
o Influences through reason
o Actively seeks to understand other perspectives
o Articulates business impact
o Matches communication to audience
o Builds consensus
o Communicates effectively with internal/external stakeholders
o Encourages ideas from others
o Explains complex issues
o Actively influences others without a direct reporting relationship
· Strategic Thinking
o Make connections between organization, team, product, ideas, etc.
o Demonstrates some understanding of implications of strategic decisions
o Seeks more knowledge of industry, competitors
o Welcomes change
· Execution and Accountability
o Identifies and resolves complex problems
o Delegates to team and keeps them focused
o Identifies and implements best practices
o Identifies and drives priorities
o Takes charge of removing obstacles to project
o Evaluates resource needs
o Creates and communicates solutions for unpopular business needs
o Meets corporate timelines
· Global Mind Set
o Demonstrates basic understanding of global environment
o Build relationships with global colleagues
o Demonstrates understanding and respect for cultural differences and needs
o Inclusive in interaction with others
o Embraces diversity of thoughts, ideas, and approaches
· MD, PhD or PharmD preferred