Clinical Research Scientist
The Clinical Research Scientist reporting to the Sr. Director of Clinical Research or Principal Clinical Research Scientist, develops and writes clinical documentation including clinical protocols, clinical study reports and clinical justifications in support of research and new product development, registration and commercialization of products. The scientist works on complex projects requiring state of the art knowledge in infectious diseases and oncology molecular diagnostics.
- Work closely with cross-functional teams (Clinical Affairs, Medical Affairs, Regulatory, R&D, Quality) to strategize and compile clinical data to support current and new products submissions per EU Invitro Diagnostics Device (EU IVD) regulations.
- Provide scientific support by interpreting safety and efficacy results data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
- Assess clinical evidence and state of the art in medicine related to the products and intended use to demonstrate safety and performance.
- Develop and write high quality clinical plans and reports with minimal supervision. Support development and drafting of clinical study protocols, and other study materials as needed.
- Collaborate with a multidisciplinary team in the development and, creation of study protocols in clinical procedures
- Prepare scientific content of clinical study reports
- Review clinical section for regulatory submissions
- Conduct comprehensive literature searches for product/technology evaluations and will write ad hoc reports based on these literature searches towards regulatory submission.
- Ensure that activities are conducted in compliance with current applicable regulations, laws and guidance including but not limited to US and EU regulation as well as with policies and procedures.
Bachelor’s, Masters or PhD or equivalent experience
2-3 years of relevant experience in the medical device or diagnostics industry, in particular within clinical development
Experience with in vitro diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics and oncology
Strong interpersonal, written communication, and presentation skills
Good problem-solving skills
Performance oriented with ability to work along agreed timelines with a focus on execution
Fluent in English (verbal and written communication) and proficient in scientific writing, editing, proof reading skills, including spelling, grammar and formatting
A Bachelor’s degree in Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology with 2+ years of related experience or a, Masters degree with 0-2 years of related work experience.
Strong scientific background with deep understanding of infectious diseases, oncology and the molecular diagnostic area
Preferred experience in IVDD/IVDR or MDD/MDR regulations
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.