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Clinical Scientist III

Irvine, CA 92612

Posted: 02/27/2024 Employment Type: Contract Job Category: Scientific Job Number: 599639 Is job remote?: Yes Country: United States

Job Description


Target PR Range: 55-65/hr
*Depending one experience

Position Summary:
As a Clinical Scientist III, Clinical Development (Devices), you will fulfill the role of scientific director or scientist in global and/or regional clinical trials. You will work with cross-functional teams developing new products or expand indications for existing products. You will participate in internal process improvement activities within R&D and Clinical Development, and mentor junior team members.
Responsibilities:
Help develop program strategy especially with regards to clinical evidence generation. Support the development of clinical development plan, product lifecycle plans, target product profiles and draft labels. Review competitive landscape and help identify and evaluate business development opportunities.
Review, interpret and communicate 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
Lead the scientific/clinical aspects of the execution of the defined Clinical Development Plan
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
Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for product lifecycle management
Serve as the key Clinical Development contact for the Integrated Evidence Strategy Team (IEST). Provide scientific/clinical oversight for the clinical trial in collaboration with the Clinical Sub-team members. Is responsible for:
• Providing focused scientific and clinical study support from start-up clinical study report
• Providing scientific content of Study Protocols, Investigator Brochures, IDFUs, Clinical Study Reports, Informed Consent Forms, and regulatory documents
• Contributing to the creation of electronic database, investigator meetings, and associated training documents
• Reviewing data completeness and fidelity throughout study conduct
• Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the IEST
Qualifications:
• Advanced degree in a scientific discipline (e.g., PhD, PharmD, MD, M.Sc) is required; experience in aesthetic medicine and/or regenerative medicine (medical device) is preferred.
• Minimum 7 years of overall work experience or equivalent combination of experience and education in clinical/biomedical research is required.
• Minimum 5 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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