Clinical Development Lead
3 weeks ago
Job Type: Long-term Contract (Possibility Of Further Extension)
Location: Pleasanton, CA (Hybrid and Remote work possible)
Company Benefits include:
- Healthcare (Medical, Dental, & Vision)
- Paid Sick leave
- 401k (with 2% employer match)
Roles & Responsibilities:
- Provide clinical guidance for the development of new laboratory and digital diagnostic products
- Identify unmet medical needs and define clinical requirements for products
- Lead clinical development and validation strategy for product registration
- Assist with regulatory submissions and provide responses to regulatory agency questions
- Work with cross-functional teams to design, implement, and publish clinical research studies
- Present research findings and provide clinical expertise for risk and safety assessments.
Education & Skills:
- Graduate work in microbiology, virology, or immunology; MD and/or PhD preferred
- 3+ years clinical experience in infectious diseases clinical care or medical microbiology/virology
- 1+ years of clinical research experience, with knowledge of clinical trial design and statistical methods
- Experience in laboratory techniques related to infectious diseases
- Excellent organizational, communication, and project management skills
- Ability to interface with key opinion leaders and clinical laboratorians
- Laboratory work experience
- Expertise in epidemiology, biostatistics, or public health
- Some experience in diagnostics, medical devices, or pharmaceutical industry
- Familiarity with regulatory processes and clinical software development
- Expertise in relevant clinical areas such as immunocompromised host, sepsis, hepatitis, respiratory infections, or clinical immunology
Interested? Please reply with your resume and contact details to hr@dawarconsulting.com .
Best Regards,
Dawar Consulting Inc.
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