Allergan Manager, Clinical Development in Irvine, California
Manager, Clinical Development
Irvine, California, United States at http://agn.referrals.selectminds.com/jobs/728/other-jobs-matching/location-only
Sep 30, 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 Manager, Clinical Development position includes the following responsibilities:
Support the Clinical Team Lead in developing Clinical Development Plans, protocol synopses, and protocols. Search, compile and summarize research literature and scientific overviews to support the clinical research to broaden the understanding of current research in the field. Prepare background summaries for clinical research and regulatory documents
Develop scenarios, scientific summaries, timeline and budget summaries for due diligence and business development activities with the directors in the TA. Plan and coordinate Expert panels/Advisory boards. Support of the Clinical Team Lead in the team meetings
Support the clinical team to close-out clinical studies/programs by defining the per-protocol population and completeness of the analysis plan. Support the topline preparation and clinical study report completion
Liaison of the TA to Regulatory Affairs and other departments to support compilation and updating of regulatory and other documents
The employee must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regulatory requirements (ICH, PhRMA, and CFR guidelines). Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Main Areas of Responsibilities
Supports the clinical team under the guidance of a Clinical Lead in designing the clinical program
Compiles the literature relevant to the therapeutic area and indication to support the development of clinical programs
Summarizes literature and scientific overviews to understand current research in the field and the competitive environment
Assists in the development of Clinical Development Plans, protocol synopses, and protocols
Assists Clinical Lead in coordination of clinical team activities (e.g. liaison with Data Management, Biostatistics, Regulatory, Medical Safety Physician)
Support the clinical team under the guidance of a Clinical Lead to close-out a clinical study and summarize the program
In collaboration with the Clinical Team Lead and Clinical Scientist supports and plans expert panels/Advisory board meetings
BS or BA with ideally at least 8 years pharmaceutical industry or clinical medicine experience OR
Master’s degree with ideally at least 5 years pharmaceutical industry or clinical medicine experience; minimum three years direct clinical research/development experience in a global organization
PhD, MD, or PharmD a plus, but not required
Ideally at least 5 years experience with clinical trial design and development of global clinical programs, including at least 3 years in the conduct of clinical studies
2 years therapeutic area experience preferred, but not required
Knowledge of regulatory requirements and GCPs
Ability to Travel up to 25%