Clinical Development Lead (Infection and Immunity)

Dawar Consulting, Inc.

Pleasanton, CA

Vision , Medical , Dental , Retirement
Full-Time

Job Description

Company Info

Job Description

Our client, a world leader in Pharmaceuticals & In vitro diagnostics (IVD), is looking for a "Clinical Development Lead" for their Infection and Immunity department. The team is dedicated to providing clinical guidance and developing new laboratory and digital diagnostic products in the areas of infectious diseases and immunology. They are committed to addressing unmet medical needs and ensuring the products are safe, effective, and clinically useful.

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