Clinical Development Lead

Innova Solutions; Pleasanton (CA); Remote; Full time

Job summary

Innova Solutions is hiring a Clinical Development Lead for Infection and Immunity. This role involves providing clinical guidance for developing new diagnostic products in infectious diseases and immunology. Candidates should have a strong background in microbiology or a related field, and possess significant clinical research experience.

Benefits

Medical & pharmacy coverage

Dental / vision insurance

401(k)

Health saving account (HSA)

Flexible spending account (FSA)

Life Insurance

Short term and Long term Disability

Employee Assistance Program (EAP)

Qualifications

• 1+ years of clinical research experience required.
• Thorough knowledge of clinical trial design and statistical methods.
• Experience with diagnostic techniques in infectious diseases preferred.

Responsibilities

• Provides clinical guidance for product development in infectious diseases.
• Leads exploratory studies and defines clinical utility claims.
• Works with Clinical Operations on clinical research studies.

Skills

Organizational skills

Communication skills

Project management skills

Education

Graduate work in microbiology, virology, or immunology

Completion of an MD and/or PhD

Tools

PCR

Sequencing

Clinical practice knowledge

Job description

Innova Solutions is immediately hiring for an Clinical Development Lead, Infection and Immunity

Position type : Full-time; Contract

Duration : 16+ Months

Location : 100% Remote

Pay range : $85 - $95 / hr on W2

As a Clinical Development Lead Professional you will :

Job Description :

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`s Diagnostic Solutions (RDS).
• 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.
• 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.
• Identifies areas of unmet medical need for diagnostics.
• Leads exploratory studies to guide product development and generate intellectual property.
• 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.
• 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.
• Develops product specifications to ensure that products will be safe, effective and clinically useful.
• 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.
• Presents research findings in meeting abstracts and publications.
• Provides 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 for clinical research. More experience is 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 in at least one of the following areas (more are preferred) : PCR, sequencing, serology, microbiology, clinical virology.
• 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 in medical microbiology / virology. Board certification is a plus.
• Laboratory work experience.
• Expertise in epidemiology, biostatistics, implementation science or other aspects of public health.
• 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.
• Experience with the development of clinical software.
• 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.
• The ideal candidate will have : 1+ years of clinical research experience, with thorough knowledge of clinical trial design and statistical methods for clinical research.

Thank you!

Lead – Recruitment

PAY RANGE AND BENEFITS :

Pay range : $85 - $95 / hr

• Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits : Innova Solutions offers benefits( based on eligibility) that include the following : Medical & pharmacy coverage, Dental / vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).