Clinical Development Lead, Infection and Immunity - Remote, United States - IT ENGAGEMENTS INC

Description

Job Description

Greeting from IT Engagements.

We IT Engagements is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. We have an immediate opening for the below position with one of our premium clients.

Position: Clinical Development Lead, Infection and Immunity (W2 Role)

Location: Remote location

Basic Functions and General Scope:

The Clinical Development Lead, Infection and Immunity, provides clinical guidance for the development of new laboratory and digital diagnostic products in the areas of infectious diseases and immunology at Client area. The lead identifies unmet needs for new products, defines their clinical requirements, contributes to early research and development, and, as the clinical leader on cross-functional project teams, leads the clinical development and validation strategy to register these products as In Vitro Diagnostics with regulatory agencies.

This position may be based out of Pleasanton, California, USA, with remote work locations possible. The position will report to the Head of Clinical Development, Infection and Immunity, in the Clinical Development and Medical Affairs department. There will not be positions reporting administratively into this role, but the incumbent is expected to function as a leader of matrixed teams and to mentor and supervise the work of junior members of the department and to foster individual development throughout the organization.

Specific Responsibilities:

• Serves as a medical leader and expert, keeping the company abreast of advances in clinical medicine, health systems and public health relating to infectious diseases and immunology, and connects the company to external experts and stakeholders.
• Provides clinical expertise for medical risk and safety assessments.
• Presents research findings in meeting abstracts and publications.
• Works with Clinical Operations to design, implement, interpret, report and publish clinical research studies to support product registrations. Identifies suitable academic partners, external laboratories and clinical sites to participate in clinical studies.
• Develops product specifications to ensure that products will be safe, effective and clinically useful.
• Assists Research and Development Groups with target product profiles and design choices. and the design of performance verification and troubleshooting experiments. Reviews the data from these experiments from a clinical perspective.
• Defines potential clinical utility claims for products. Provides medical/scientific input into and assists with the preparation of regulatory submissions. Provides responses to regulatory agency questions.
• Leads exploratory studies to guide product development and generate intellectual property.
• Identifies areas of unmet medical need for diagnostics.

Position Requirements:

• Graduate work in microbiology, virology, or immunology; Completion of an MD and/or PhD preferred.
• Experience interfacing with key opinion leaders including physicians and clinical laboratorians.
• Excellent organizational, communication, and project management skills.
• Understanding of laboratory techniques in infectious diseases in at least one of the following areas (more are preferred): PCR, sequencing, serology, microbiology, clinical virology.
• Proven ability to design clinical trials, critically evaluate study results, and write protocols, study reports and publications.
• 1+ years of clinical research experience, with thorough knowledge of clinical trial design and statistical methods for clinical research. More experience is preferred.

Preferred:

• 3+ years clinical experience in infectious diseases clinical care or in medical microbiology/virology. Board certification is a plus.
• Experience with the development of clinical software.
• Experience within the diagnostics, medical device or pharmaceutical industry, with an understanding of the product development process, regulatory processes, and a track record of regulatory approval based on clinical trials.
• Expertise in epidemiology, biostatistics, implementation science or other aspects of public health.
• Laboratory work experience.
• Expertise in one or more of the following clinical areas: (a) immunocompromised host, HIV, transplant; (b) sepsis; (c) hepatitis; (d) respiratory infections; (e) clinical immunology.

Thanks