Staff Scientist Method Development- Vaccines

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Job Responsibilities

• Responsible for designing and developing new serological binding assays (ELISA, Luminex) for support of vaccine candidate clinical trials.
  Has the ability to work as an independent investigator. Independently plans and executes laboratory research.
  Responsible for the successful qualification or validation of serological assays.
  Able to lead junior scientists in developmental, qualification and/or validation activities.
  Writes, assists, or supervises the writing of protocols and reports, SOPs, forms, and worksheets for new assays, converted assays, updates to existing assays, and transferred assays.
  Scientific responsibility to monitor assays after they are put into clinical testing.  Assists in troubleshooting technical problems as needed.
• Work closely with the Clinical Operations, Clinical Sciences and Global functional teams to ensure the translation of the protocol and clinical development plans into executable operational processes.
• Lead internal or external training as required and support the medical monitor in responses to investigators and other site personnel regarding clinical and study conduct questions.
• Independently review study subject level data for presentation to the medical monitor for clinical decision making, throughout the study life cycle. Liaises closely with the clinical safety scientist to support ongoing aggregate safety data review during a given clinical study.
• May manage alone or in collaboration with clinical safety the operational functioning of data monitoring committees and/or clinical adjudication committees. Clinical Scientist may participate in and present at these meetings, as required.
• Participate in analyzing and interpreting data from clinical studies, and writing/editing or reviewing results in study reports, regulatory submissions, abstracts, posters, presentations, peer reviewed manuscripts, and other documents. As required, lead internal data review meetings to determine strategic interpretation.
• May become a member of the company publication group. Additionally serve as a scientific reviewer for company publications and external research proposals in the area(s) of expertise.
• Participate in the Clinical Operations and Clinical Development teams. Provide support to the clinical development team (CDT) through meeting management support and communication.
• Act as the delegate or lead where required.
• Interact with internal auditing groups on a study level to ensure clinical development activities are conducted according to internal SOPs and work practices and in compliance with ICH-GCP.

Minimum required education and experience

• Must have strong background in development of ELISA and/or Luminex assays for the detection and quantification of human antibodies.
• Bachelor's with at least 5 years’ experience in assay development.

Skills and abilities

• Excellent communication (interpersonal, verbal and written) skills, ability to communicate effectively at all levels.
• Ability to work with global teams
• Knowledge of Health/Safety and Environment good practice.
• Duty to comply with all applicable standards as required by the company
• Experience in GLP laboratory environment.
• Have an understanding of all routine laboratory procedures.
• Ability to maintain clear and efficient documentation.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.