Clinical Scientist II
2525 Dupont Dr Irvine, CA 92612 US
Target PR Range: 40-50/hr
*Depending one experience
As a Clinical Scientist II, Clinical Development (Devices), you will fulfill the role of Clinical Scientist or Clinical Science Lead in global and/or regional clinical trials. You will work with cross-functional teams developing new products or expand indications for existing products. You are also expected to participate in internal process improvement activities within R&D and Clinical Development, and mentor junior team members.
Lead or contribute to the design, conduct, analysis, and reporting of clinical trials. Apply scientific training and clinical research experience to support all aspects of device product development, from facilitating the transition from preclinical discovery to supporting the registration and commercialization of a product.
• Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of products in development. Attend congress and review literature to develop and augment expertise in aesthetic medicine
• Help develop program strategy including the clinical development plan and integrated evidence plan, product lifecycle plans, target product profiles and draft labels.
• Responsible for providing focused scientific and clinical study support from start-up clinical study report
• Participate in scientific education of internal and external stakeholders on the pre-clinical and clinical data relevant to the program. Engage opinion leader interactions to build pipeline awareness and foster research collaborations
• 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
• Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for product lifecycle management
• Advanced degree in a scientific discipline (e.g., PhD, PharmD, MD, M.Sc) is required; Scientific knowledge and experience in aesthetic medicine and/or regenerative medicine (medical device) is preferred.
• Minimum 5 years of overall work experience or equivalent combination of experience and education in clinical/biomedical research is required.
• Minimum 2 years of pharmaceutical/device industry experience in clinical/research is required.
• Ability to travel up to 15% of time, including international travel
*CO/NYC candidates might not be considered
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