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GSK

Director, Cellular Biomarkers

A new role requirement identified to lead the newly formed Cellular Biomarker group of approximately 20 scientists that will support clinical biomarker testing by establishing and implementing cutting-edge technologies necessary to enhance immunophenotyping analytical capabilities at GSK. As R&D shifts our focus toward immune regulation, presenting substantial challenges of high system complexity and heterogeneity, the cellular biomarker group is established to provide R&D the biomarker platforms necessary for phenotypic characterization of specific immune cell subtypes in tissues or cell suspensions, informing and shaping understanding of patient-specific disease signatures and treatment responses. Such analyses will require a collection of different analytical tools such as flow cytometry, immunohistochemistry, cellular imaging and genomics.

The successful candidate will have demonstrated her/his strong understanding on current advances in biomarker technologies (e.g., immunohistochemistry, flow cytometry, genomics, informatics, cellular imaging) and their application in support of clinical studies (e.g., hypothesis testing, immune profiling, and patient selection). The 'window of opportunity' likely best resides with early clinical studies where we can deploy multiple platforms to investigate and define mechanisms-of-action and treatment effects; providing target engagement/co-localization, pharmacodynamic (PD) and phenotypic/genotype analyses to efficiently enable clinical decision around dose selection and indication expansion.

Key Responsibilities

• Establish and lead a group of cellular biomarker assay scientists focusing on immunohistochemistry, flow cytometry, genomics, cellular imaging and other emerging technologies to deliver fully functional immunophenotyping biomarker platforms in support of clinical and enabling non-clinical studies.
• Lead the effort to implement novel immunophenotyping biomarker platforms at GSK (e.g., NGS, Nanostring, CyTOF) and work with partners to develop capabilities in Informatics/Data Analytics/Statistics around the aggregation, collection, and interpretation of the high content biomarker data, facilitating effective clinical trial application, and data reuse for institutional knowledge and cross-trial comparisons.
• Lead the interface and collaboration between this team and biomarker scientists in Research Units, clinical biomarker scientists in CPEM, and pathologists to facilitate biomarker assay development and study support from drug discovery throughout development.
• Champion the effort to translate a project team's biomarker needs into a fit-for-purpose biomarker assay and act as an analytical scientific expert in discussions on science/project progression within GSK, bringing rigor and quality to biomarker endpoints. Balance stakeholder expectations with scientific quality and validation requirements ensuring limitations of assays and data are well understood.
• WW resource planning - provide study priorities, manage both internal and external resources, negotiate timelines, and regularly evaluate and prioritize departmental activities.
• Keep abreast of changes within GSK and the industry, and build relationships external to BIB. Works strategically across matrix teams to ensure strong connectivity with key stakeholders, constantly looking for new opportunities to add additional value to drug development at GSK.
• Provide senior scientific leadership and set strategic direction regarding technology advancement. Drive an assay technology agnostic attitude and openness to new technologies.
• Actively contribute to the development and implementation of the BIB departmental strategy (people, scientific, regulatory/quality and contracting). Communicate and embed the strategy and vision to group members



Required Experience

Minimum 6 years experience in this area

• Experience leading a multi-functional group responsible for delivering project direct cellular biomarker support of immunophenotyping.
• Extensive knowledge of immunophenotyping technology platforms (e.g., immunohistochemistry, flow cytometry, genomics, informatics, proteomics, imaging), and ability to apply their experience to drug discovery, development or post-marketing area issues
• Strong experience leading teams of scientists, interacting with project and regulatory teams, and delivering high quality data for nonclinical and clinical studies.
• Track record of managing complex technical, scientific and operational activities and in leading, developing and motivating teams
• Strong external profile and key opinion leadership. Well connected with the leading relevant industry peers, regulatory development and academic thought leaders.
• Has the necessary experience and knowledge to represent the department in regulatory interactions (questions, filings) and at high level regulatory meetings (e.g. with FDA, EMA, MHRA).
• Scientific and regulatory knowledge for working with biofluid and tissue samples, animal or human; accountable for compliance aspects, sample and data management, reporting requirements.

This role can be based in USA or UK.

Closing date for applications: 30th March 2019

When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.

If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

Thank you for your interest in this opportunity.

*LI-GSK

Why You?Basic qualifications:
PhD or equivalent
Immunology, cellular biology, histology, pathology or related field

Role requires in depth technical knowledge of immunophenotyping analytical platforms for clinical biomarker applications, and understanding of data analytics, informatics, statistics and training/experience to a doctorate level.

Preferred qualifications:
PhD

Immunophenotyping technology platforms (e.g., immunohistochemistry, flow cytometry, genomics, informatics, proteomics, cellular imaging) in a drug discovery and/or development environment.

Proven academic expertise in one or more aspects relevant to immunophenotyping is desirable. Position requires strong scientific background in the fast development areas of immunophenotyping/cellular biomarker and training/experience to a doctorate level

Why GSK?:
GSK:
GSK is a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We have a significant global presence with commercial operations in more than 150 countries, a network of 89 manufacturing sites, and large R&D centres in the UK, USA, Belgium and China.

At GSK we are leaders in what we do - our pharmaceuticals business is made up of innovative and established medicines and holds leading positions in respiratory disease and HIV, in 2015 we distributed more than 690 million doses of vaccines to over 150 countries, and our Consumer Healthcare group has a portfolio of some of the world's most trusted and best selling brands. As a company our mission is to help people do more, feel better, live longer.

To find out more about life at GSK, click here.

Contact information:
You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. 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.

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