Clinical Development Lead

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.

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you! PATHAN​ SAMIULLAHKHAN Lead - Recruitment (+1) 971-925-2783 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). ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Website : Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-5588 . Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws. American Cybersystems, Inc is acting as an Employment Agency in relation to this vacancy.