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    Clinical Development Lead - Remote

    Maxis Clinical Sciences
    3+ years
    $45 to $95 per hour
    Pleasanton Remote, USA
    10 July 31, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Clinical Development Lead, Infection and Immunity

    Location: Remote (Please indicate candidate's location on the resume)

    Basic Functions and General Scope: The Clinical Development Lead, Infection and Immunity, is responsible for guiding the development of new laboratory and digital diagnostic products in the fields of infectious diseases and immunology at [Client's Diagnostic Solutions]. This role involves identifying unmet medical needs, defining clinical requirements, and leading the clinical development and validation strategies to achieve regulatory approval for new In Vitro Diagnostics products.

    This position may be based in Pleasanton, California, USA, with the possibility of remote work. The incumbent will report to the Head of Clinical Development, Infection and Immunity, within the Clinical Development and Medical Affairs department. While this role does not have direct reports, it requires leadership of cross-functional teams and mentoring junior members to foster individual development within the organization.

    Specific Responsibilities:

    • Serve as a medical leader and expert, keeping the company informed of advances in clinical medicine, health systems, and public health in infectious diseases and immunology.
    • Identify areas of unmet medical need for diagnostic products.
    • Lead exploratory studies to guide product development and generate intellectual property.
    • Define potential clinical utility claims for products, provide medical/scientific input, and assist with regulatory submissions and responses to regulatory agency inquiries.
    • Collaborate with Research and Development groups on target product profiles, design choices, and performance verification experiments, and review clinical data.
    • Develop product specifications to ensure safety, effectiveness, and clinical utility.
    • Work with Clinical Operations to design, implement, interpret, report, and publish clinical research studies supporting product registrations. Identify and engage academic partners, external laboratories, and clinical sites.
    • Present research findings at meetings and in publications.
    • Provide clinical expertise for medical risk and safety assessments.

    Position Requirements:

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

    Preferred Qualifications:

    • 3+ years of clinical experience in infectious diseases clinical care or medical microbiology/virology. Board certification is a plus.
    • Laboratory work experience.
    • Expertise in epidemiology, biostatistics, implementation science, or other public health areas.
    • Experience in the diagnostics, medical device, or pharmaceutical industries, with a track record of regulatory approval based on clinical trials.
    • Experience in developing clinical software.
    • Expertise in clinical areas such as immunocompromised host, HIV, transplant, sepsis, hepatitis, respiratory infections, or clinical immunology.

    About Maxis Clinical Sciences: Maxis Clinical Sciences provides comprehensive solutions for Clinical and Digital Services, recognized for its integrated research competence center. Operating globally, Maxis offers 24×7 delivery with teams across North America, Europe, and Asia, promoting genuine relationships and steady communication. Maxis specializes in clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting, data anonymization, and RWD aggregation and curation services.

    For more information, visit www.maxisclinical.com.

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