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Associate Director, Diagnostics Precision Medicine

Stevenage

Job Type

Job Function

Medical and Clinical

Location

Stevenage

On-Site or Remote

Job Type

Salary

Competitive salary and benefits

About the Role

*Job description* *Site Name:* USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, USA - Massachusetts - Boston *Posted Date:* Jan 26 2024 *This role will be located in Waltham MA or Collegeville PA or Stevenage UK only.* Are you a professional in the diagnostics field looking to advance your career? If so, this *Associate Director- Diagnostics Precision Medicine *role may be an ideal opportunity to explore! As a Diagnostics (Dx) team member you will contribute to efforts to implement GSK diagnostics strategy(s) to support drug development including technical, clinical, regulatory, commercial, intellectual property and business development components by leading diagnostic projects and work streams according to agreed deliverables, timelines and budget. In this role, you will have the opportunity to lead the development and commercialization of diagnostics and as required companion diagnostics across therapeutic areas including Oncology, Respiratory/Immunology, and infectious diseases The Associate Director will be part of a team that leads and contributes to Dx development with a culture of collaboration, diversity, equity, and inclusion embracing precision medicine in drug development. *Responsibilities include:* *This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:* - Help develop and lead end-to-end diagnostic strategy within early and late-stage therapeutic clinical studies to align all diagnostic development milestones with clinical development milestones and overall translational biomarker strategy. - Accountable for all aspects of diagnostic development with external partners to develop, validate and implement diagnostic tests required for specific clinical studies. - Oversee all technical aspects of development, validation and clinical implementation of the diagnostic assays within a clinical study. - Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with all regulatory requirements. - Exhibit timely management and delivery of projects/work streams within agreed budget. - Works within, and may lead, matrix teams to ensure efficient implementation of all key deliverables for the diagnostic project. - Supports regulatory interactions by contributing to the writing and the review of diagnostic portions of briefing documents, informed consents, clinical protocols, schedule of activities, clinical study reports, IDE and PMA regulatory submissions. - Where applicable, contributes to the implementation of strategies to manage risks on clinical study timelines, budgets and goals. Contributes to decisions which balance risk/benefit with clear understanding of impact on project. - Builds and maintains networks with clinical study teams, regulatory, clinical and biomarker leads, TA heads, project management, finance, business operations and IVD partner joint project team members to ensure timely dissemination of information to appropriate levels to improve transparency. - Provides frequent clinical study updates related to diagnostic project deliverables to management and to study level matrix teams, both internally and externally. - Liaises with asset teams, regulatory, clinical and biomarker leads, TA heads, and IVD partner joint project team members - Works with clinical, regulatory, operations, policy, BD and business unit colleagues and key leadership within project teams - Works with asset leads and Dx regulatory leads to ensure efficient implementation of all key deliverables for the Dx - Where applicable, accountable for implementing key organizational process improvement initiatives in daily activities. - Where applicable, anticipate in the evaluation of advanced technologies for IVD and clinical biomarker development. *Why You?* *Required Qualifications* *We are looking for professionals with these required skills to achieve our goals**:* - Advanced degree in Biological sciences; - Ph.D. with 3 or more years of pharmaceutical and/or IVD manufacturer experience or - B.S or M.S. with 5 years or more years of pharmaceutical and/or IVD manufacturer experience - Experience in clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management and human biological specimen management - Experience in clinical/translational biomarker investigation including biomarker operations and data management. - Experience with IVD development including design history file evaluation, risk assessments and all related analytical and clinical validation requirements. - Experience in technical platforms that include IHC, immunoassay, PCR, NGS and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies). - Experience with MS Office products (Word, Excel, PowerPoint, SharePoint, Project) and remote meeting tools such as MS Teams *Preferred Experience* *If you have the following characteristics, it would be a plus:* - Experience in drug and/or Dx development in at least one therapeutic area - Experience in performing due diligence and auditing vendors for clinical test execution. - Familiarity with clinical laboratory and medical device requirements including: GCP/GCLP, CLIA, CAP, ISO15189, QSR regulations, GMP manufacturing, ISO13485, including FDA/US and EMA/EU. - Experience in diagnostic product development (pre-submission packets, SRD and IDE authoring and HDE/510k/PMA documentation) for class II and/or class III devices including: companion/ complimentary diagnostics and surrogate efficacy biomarkers. - Knowledge of US and Ex-US testing and regulatory landscape, including evolving IVDR requirements in the EU. - Able to manage multiple projects including assessment of workload and resourcing requirements to deliver the team’s objectives. - Detail oriented with strong organization skills. - Exceptional written and verbal communication skills. - Good track record working within a matrix team environment. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. *Why Us?* GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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. *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 site.

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