Clinical Development Manager

Clinical Development Lead, Infection, and Immunity

Job Location: 100% Remote

Basic Functions and General Scope:

The Clinical Development Lead, Infection and Immunity, plays a pivotal role in providing clinical guidance for the development of new laboratory and digital diagnostic products focusing on infectious diseases and immunology at client. This role involves identifying unmet needs for new products, defining their clinical requirements, contributing to early research and development, and leading the clinical development and validation strategy to register these products as In Vitro Diagnostics with regulatory agencies.

Specific Responsibilities:

• Serve as a medical leader and expert, staying updated on advances in clinical medicine, health systems, and public health related to infectious diseases and immunology.
• Identify areas of unmet medical need for diagnostics and lead exploratory studies to guide product development.
• Define potential clinical utility claims for products and provide medical/scientific input into regulatory submissions.
• Collaborate with Research and Development Groups on target product profiles, design choices, and the design of performance verification experiments.
• Develop product specifications to ensure safety, efficacy, and clinical usefulness.
• Work with Clinical Operations to design, implement, interpret, report, and publish clinical research studies.
• Provide clinical expertise for medical risk and safety assessments.

Position Requirements:

• Graduate work in microbiology, virology, or immunology; Completion of an MD and/or PhD preferred.
• 1+ years of clinical research experience with thorough knowledge of clinical trial design and statistical methods.
• Proven ability to design clinical trials, evaluate study results, and write protocols, reports, and publications.
• Understanding of laboratory techniques in infectious diseases.
• Excellent organizational, communication, and project management skills.
• Experience interfacing with key opinion leaders including physicians and clinical laboratorians.

Preferred:

• 3+ years clinical experience in infectious diseases clinical care or medical microbiology/virology.
• Laboratory work experience.
• Expertise in epidemiology, biostatistics, implementation science, or other aspects of public health.
• Experience within the diagnostics, medical device, or pharmaceutical industry.
• Experience with the development of clinical software.
• Expertise in clinical areas such as immunocompromised host, HIV, sepsis, hepatitis, respiratory infections, or clinical immunology.