Develop, lead, and coordinate activities related to the development and commercialization of companion diagnostics across multiple therapeutic areas, with a focus on the safe and effective implementation of companion diagnostics in patients with cancer. Accountable for all aspects of companion diagnostics development, from research study design through to clinical implementation. Play a critical role throughout the companion diagnostic development process. Lead companion diagnostics strategy within early and late-stage therapeutic oncology programs to align companion diagnostic development milestones with associated clinical development milestones and overall biomarker strategy for GSK's oncology assets currently in development. Oversee the technical aspects of development, which includes assay validation and clinical implementation of the selected assays. Ensure that diagnostic testing and data generation is compliant with all regulatory requirements for advancing devices through development and onto the market. Support scientific work and develop research studies related to companion diagnostic development. This includes participating in the scientific evaluation of advanced technologies for in vitro devices (“IVD”) and clinical biomarker development. Provide support for product claims and provide consultation, review, and guidance to support product registration with regulatory bodies. Author companion diagnostic portions of informed consents, clinical protocols, schedule of activities, clinical study reports, Investigational Device Exemption (IDE) and Premarket Approval (PMA) regulatory submissions. Work with an external IVD partner to develop, validate, register, and commercialize companion diagnostic tests for prospective patient selection.Basic Qualifications
Must have a Master's degree (or foreign equivalent) in Pharmaceutical Sciences or a related field and 4 years of experience in: (1) Work with a cross-functional team with limited guidance that supports clinical trials testing new targeted anti-cancer drugs, by developing tailored companion diagnostic assays; (2) Design and conduct studies with independence, including troubleshooting as required; (3) Evaluate performance testing of companion diagnostic assays including, IHC, FISH, NGS, or PCR assays; (4) Support clinical trial activities including preparation of study materials and training of study personnel; (5) Define and design the optimal development path for each product within our workflow and adhering to a quality management system framework; and (6) Evaluate and report experimental results. Generation of general protocols, reports and publications.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record