Description

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. The Manager, Clinical Development (Devices) will have global or regional responsibilities and fulfill the role of Clinical Scientist within the Integrated Evidence Strategy Team (IEST). The Manager, Clinical Development should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members.

The position will be based in Irvine, CA.
 
YOU ARE more than just a title, YOU ARE…

First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. 

You Will 

In collaboration with a Therapeutic Area Scientific Director (TA-SD), the Clinical Scientist will contribute to the design, conduct, analysis, and reporting of clinical trials. The Clinical Scientist will apply scientific training and clinical research experience to support all aspects of device and product development, from facilitating the transition from pre-clinical discovery to supporting the registration and commercialization of a product. 

The position supports the Global Development Lead, TA-SD through the following responsibilities:

• Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of products in development. Attends congress and reviews literature to develop and augment expertise in therapeutic area
• Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR).
• Participate in scientific dialogue with internal and external stakeholders on the clinical data relevant to program.
• Contribute to the scientific content of Study Protocols, Investigator Brochures, IDFUs, Clinical Study Reports, Informed Consent Forms, and regulatory documents.
• Contribute to creation of electronic database, investigator meetings, and associated training documents and review data completeness and fidelity throughout study conduct.