Assoc Dir, Biological Research Device

Allergan, Inc. Irvine, CA
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.

Position Overview

Under limited guidance, the incumbent will be responsible for executing research in support of Allergan's dermal aesthetics and plastic & reconstructive surgery business franchises. The focus of such studies will be to evaluate the interaction of current and future medical device biomaterials with cells and tissues for purposes of establishing device proof of concept, completing regulatory submission-related studies (ISO 10993 biocompatibility), and executing biological competitor differentiation research for promotional support. The incumbent is expected to establish and manage high value research agreements with contracted research organizations, partner businesses, and academic institutions as relevant. Test methods for which competency is expected, will consist of non-GLP and GLP in vivo modeling as well as in vitro methods including cell culture/cell-based assay development, flow cytometry, PCR, histology, immunohistochemistry, ELISA/multiplex, and mechanical tissue testing.

In addition, the incumbent will serve as the preclinical representative to cross-functional development teams, with responsibility for planning and executing on research strategies. As a senior member of the preclinical team, this individual is expected to be a strong scientific and developmental mentor to more junior staff, manage high volume workload, and routinely engage key stakeholders, including therapeutic area and technical leads across R&D disciplines.

Main Areas of Responsibilities

* Responsible for development of products, including scientific strategy and realistic deliverables with timelines. Actively involved in the planning, execution and management of experimental studies for safety and efficacy testing of novel and existing products.

* Actively works in a team environment. Frequent communication is essential and must interface with colleagues in Research, Product Development, and other internal functions as necessary (eg strategic marketing, medical affairs).

* Communicates project status to supervisor, Therapeutic Area Leads, other research managers, and R&D committees as appropriate. Prepares time and cost estimates of project activities for review by Therapeutic Area Leads to achieve realistic project completion dates.

* Writes, reviews and issues technical reports, technical memoranda, scientific publications and other documents for internal and external distribution. Works closely with Allergan patent counsel in generating IP documentation.

* Responsible for establishing new state of the art laboratory capabilities and assays, relevant to business need. Will be expected to participate in lab activities and experiments to support volume of work.

* Serve as a scientific mentor to junior staff, contributing to the planning and communication of scientific activities within the group.

Requirements

* Experience in a medical device, pharmaceutical, or related setting with a proven record of success in conducting R&D projects.

* Experience and working knowledge of medical device and/or cell & tissue-based product regulations (21 CFR 820, 21 CFR 1271, etc.) required. Knowledge of drug and/or biologics regulations are a plus.

* Experience planning and conducting/managing in vivo (small and large animal) and in vitro research activities.

* Experience managing outsourced research activities.

* Experience conducting/managing GLP toxicity and biocompatibility studies is a plus.

* Technical report writing proficiency in support of regulatory submissions.

* Creativity, strong verbal and written communication skills, strong scientific leadership skills, ability to work effectively in independent and team settings, and acute attention to detail are essential skills for this position.

Preferred Skills/Qualification

* Established ability to train scientists and develop scientific competencies within a team

* Attention to detail and quality of work required

* Good communication and documentation skills required

* Working knowledge of general laboratory techniques and procedures required

* Good quantitative and analytical skills required

* Understanding of statistical principles desirable

* Experience managing team members is highly preferred

Education

* Ph.D. and a minimum of 8+ years of industry experience or Master's degree and 10+ years of industry experience. Degree in a related scientific or engineering discipline (cell biology, molecular biology, bioengineering or similar).