Scientific Director, Immunoassays - Open to flexible working

Location
Stevenage, Hertfordshire
Salary
£Competitive
Posted
04 Jul 2022
Closes
04 Aug 2022
Ref
331974
Contract Type
Permanent

We’re currently looking to expand our Bioanalysis, Immunogenicity and Biomarkers (BIB) department and seeking a Scientific Director to join with strong exposure within Immunoassay PK and Soluble Biomarkers.

The role is based in the R&D hub in Stevenage UK or Upper Providence US with the possibility of leading staff in UK or US. Flexible and remote working are available, with periodic attendance at our UK or US offices. The role reports directly into the Senior Director, Head of Immunoassay Bioanalysis and Biomarkers.

As the successful candidate, you’ll join GSK in a high visibility role where you’ll be at the forefront of medicine while managing the full life cycle of GSKs studies. Your skills as a bioanalytical scientist with drug development and regulatory understanding you will work with internal and external partners to deliver bioanalytical endpoints for preclinical and clinical studies across the GSK portfolio. 

As a scientific leader, you will help set the scientific strategies of the Immunoassay PK and soluble biomarkers group, serve as the subject matter expert (SME) on PK and Biomarkers data deliverables using various immunoassay platforms (e.g., ELISA, Gyros, MSD, Quanterix), and manage the bioanalytical support externalized to CRO partners covering method development, assay transfer / validation (including cross validation), and for soluble biomarkers you will work closely with internal biomarker leads to define the necessary Context of Use for the data and ensure supporting analytical methods are fit for purpose.  You will monitor assay performance at CRO and ensure high quality PK and/or soluble biomarker are delivered to pre-agreed projects timelines and quality standard.

In this role you will:

The primary deliverables for the Scientific Director, Immunoassays will be to:

  • Serve as the scientific lead of the immunoassay bioanalysis and biomarkers team, responsible for driving scientific strategy of the group
  • Act as the SME for biopharmaceutical PK and soluble biomarker immunoassays, internal and external; provide technical supervision in solving issues related to PK and soluble biomarker assays in preclinical and clinical development
  • Work closely with internal clinical pharmacokinetics and biomarker leads to define the necessary Context of Use for the data and ensure supporting analytical methods are fit for purpose
  • Drive scientific and technology innovations of immunoassay for PK and soluble biomarker measurements
  • Represent the department in internal project teams and regulatory interactions (questions, and filings) related to PK/PD assays
  • Act as Sponsor Reviewer (SR) for BIB studies and study contributions outsourced to contract research organizations (CROs)
  • Acts as the primary interface for communication between GSK and CRO staff
  • Work closely with CRO partners to ensure timelines for method development and sample analysis are met and communicate any delays
  • In partnership with GSK External QA, evaluate third-party compliance with GLP, GCP Clin Lab, and worldwide regulations, relevant SOPs, protocols, policies and procedures

Why you?

Basic Qualifications & Skills:

We are looking for professionals with these required experience to achieve our goals:

  • Ph.D. or equivalent in Biomedical Sciences or related discipline
  • Experience working within the pharmaceutical industry with intimate understanding of the drug development process
  • Expertise in developing methods to support validation of biopharmaceutical PK, biomarker or immunogenicity assays
  • Experience in preparing analysis and reporting of preclinical and clinical biopharmaceutical PK, biomarker and immunogenicity data and its context to the study/project
  • Thorough understanding of GLPs, GCLPs, and regulatory guidance’s
  • Experience in representing the department at project teams and regulatory interactions (questions, and filings)
  • Accomplished data interpretation experience both bioanalytically as well as secondary outputs such as PK PD
  • Line of site to new and emerging analytical technologies
  • Excellent English spoken and written

Preferred Qualifications & Skills:

If you have the following characteristics, it would be a plus:

  • Previous global/at least regional function and experience in major pharma (regulated industry) organization are preferred
  • Experience of direct line management as well as cross-functional teams
  • Experience in study set up and management of regulated studies in Thermo Watson LIMS
  • Experience of working through contract negotiations with partners and 3rd parties
  • Excellent communication skills – will need to interface between many functional areas including external suppliers, internal study teams, SMEs and QA
  • Excellent attention to detail – reviewing validation plans, study plans, validation and bioanalytical reports, and assisting with reconciliation of study samples
  • Cultural sensitivity
  • Willingness to travel if needed

Why GSK?

At GSK, we have delivered unprecedented change over the past four years - to improve R&D productivity and performance, transform commercial execution and to , strengthen our leadership and reshape our organisation. Now, we’re getting ready to deliver the most significant change to our company in over 20 years. We’re on track to separate and create two ambitious new companies in 2022: A new GSK with a leading portfolio of vaccines, specialty and general medicines, and R&D based on the science of the immune system and genetics; and a new world-leading consumer healthcare company built on brands and innovation and delivering better everyday health.

With new ambition comes new purpose. GSK will unite science, talent, and technology to get ahead of disease together. We’ll be a company where outstanding people thrive, delivering strong, sustainable returns to our shareholders and with the power to improve the health of more than 2.5 billion people over the next 10 years.

All of this depends on our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; where we are all accountable for our impact and supported to succeed; and where we do the right thing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

R&D At GSK, we want to find new medicines and vaccines in ways that are faster, more effective and more predictable.

We start with what matters most, the science. Our approach to R&D focuses on science related to the immune system, the use of human genetics, and advanced technologies. Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including oncology, infectious diseases, immunology / respiratory and HIV. We have pivotal study starts in 2021 for our RSV vaccine in older adults, COVID-19 assets, long-acting anti-IL-5 antagonist, daprodustat, and dostarlimab. In oncology, momentum is building with 15 potential medicines in trials, including nine immuno-oncology and three cell therapies.  

We give our scientists the freedom to own the process. Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can do most good. If a project doesn’t pan out, we take what we’ve learned and apply it elsewhere.

Technology can help us find patterns in genetic data better and faster. We’re using machine learning to unlock the potential of complex genetic data with new levels of speed, precision, and scale. And we’re one of the first biopharmaceutical companies to have created an in-house AI lab dedicated to drug development.

Even with the knowledge, tools, and resources within GSK, there’s always a benefit to new perspectives. That's why we're increasingly partnering with and hiring outstanding people from cutting edge fields like tech, data-science and academia. In 2018, GSK formed an exclusive, highly innovative collaboration with 23andMe, the world's leading consumer genetics and research company. Other partners include: the Altius Institute; the UK Biobank, which is generating anonymized genetic sequence data from 500,000 volunteers; and the Open Targets Consortium, the mindset and approach of smaller, more agile startups.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers.  As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it.  Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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