Preclinical Outsourcing Specialist

Job description

Job Description

You want to see farther, and here at Alcon we have some shoulders for you to stand on. You didn't flinch from the hard courses in school and now you navigate just fine between physics and engineering, chemistry and statistics. But you're looking for more. You want to make a difference. Alcon's world-class research and development team is the place to find out how much of a difference you can make. As you work with us, you'll be able to reach the point where standard methods no longer suffice—you'll need to take your game to the next level. The challenge might be to design new concepts for intraocular lenses or novel non-clinical models for cataract surgery. It could be an assignment to collaborate on advanced analytical methods or to consult with outside specialists on new trends. At Alcon, there's a variety of scientific and technological areas to explore. Our R&D teams are already looking for better ways to improve people's eyesight and we think you can help us see a little farther too. Come and share our vision.

•The Preclinical Outsourcing Specialist is responsible for technical management of outsourced preclinical safety studies as the sponsor representative and key external relationship manager with contract research organizations (CRO), and may also provide outsourcing support for drug metabolism/pharmacokinetics (DMPK) or pharmacology.
•Manages outsourced preclinical safety studies in collaboration with Preclinical Safety (PCS) and may also manage outsourced preclinical drug metabolism/pharmacokinetics (DMPK) or pharmacology studies as needed in collaboration with Ocular Pharmacokinetics and Disposition (OPKD).
•Responsible for technical management of studies supporting pharmaceuticals, surgical devices and vision care through protocol, conduct and report phases, and for ensuring that the study conduct, record keeping and reporting are consistent with the study protocol.
•Ensure that studies are compliant with the appropriate GLP regulations/ISO guidance's, Novartis animal welfare policies, CRO standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines.
•Effectively manage multiple outsourcing studies under general supervision and produce reports per plan to acheive target deadlines.
•Responsible for communicating with outside and in-house parties to move studies forward with a sense of urgency.
•Responsible for resolution of study related issues, interaction with internal experts and informing the appropriate people in a timely manager are privotal to the performance of this role.
•Accountable for technical oversight and tracking of all study phases to ensure that the CRO meets its agreed to main reporting timelines in a quality manner.
•Responsible for interpretation of study data in collaboration with applicable subject matter experts, such as Project Toxicologist or Project Pharmacokineticist, and communication of results to the appropriate unit management.
•Exbibits strong verbal and written communication skills and strong interpersonal and leadership skills as necessary to ensure study activities are executed smoothly and according to protocol.

Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to ************@*******.** and let us know the nature of your request and your contact information.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Desired profile

•Bachelor's, Master's, or Ph.D. degree in Toxicology, Pharmacology, Biochemistry or related field.
•English
•Bachelor's degree with 8yrs experience, Master's degree with 5yrs experience, Ph.D. with 3 years experience.
•Solid scientific background in Pharmacology/Toxicology for regulatory submissions.
•Proficient knowledge of regulatory and international standard guidelines and general nonclinical study protocols (e.g. GLP, OECD, ISO 10993 and 17025, USP, USFDA)
•Experience in roles of Preclinical Study Director/Study Monitor and/or experience as a Project Team Member/Representative. Other routes into the role are possible.
•Excellence communicator, strong team player, and high level of logistical / planning ability.
•Ability to travel 10-15%.

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