Associate Director- Diagnostics Precision Medicine (Waltham)

Business IntroductionAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.Find out more:Our approach to R&DPosition SummaryAre you a professional in the diagnostics field looking to advance your career? If so, this Associate Director - Diagnostics Oncology Translational Medicine role may be an ideal opportunity to explore. As a member of the Precision Diagnostics team, you will contribute to the implementation of GSK diagnostic strategies supporting drug development, including technical, clinical, regulatory, commercial, intellectual property and business development components. You will lead diagnostic projects and workstreams according to agreed deliverables, timelines and budget, within a matrix cross-functional environment.Key ResponsibilitiesThis role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:Support development of end-to-end diagnostic strategy across early and late-stage clinical studies aligned with biomarker and clinical development plans.Accountable for tactical execution with external partners to develop, validate and implement diagnostic tests for clinical studies.Oversee technical development, validation and implementation of diagnostic assays within a clinical trial.Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with all regulatory requirements.Manage and deliver projects/workstreams within agreed timelines and budgets.Work within, and may lead, matrix teams to ensure efficient implementation of all key deliverables for diagnostic projects.Support regulatory interactions by contributing to the writing and review of diagnostic portions of briefing documents, informed consents, clinical protocols, schedule of activities, and clinical study reports.Contribute 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.Build and maintain networks with regulatory, clinical and biomarker leads, clinical study teams, project management, business operations, and IVD partner joint project team members to coordinate activities and ensure timely dissemination of information.Why You?Basic QualificationWe are seeking professionals with the following required skills and qualifications to help us achieve our goals:PhD with 3+ years OR MS with 5+ years of experience in pharmaceutical or IVD development.Experience in clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management, and human biological specimen management.Experience in 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).Preferred QualificationIf you have the following characteristics, it would be a plus:Experience in drug-diagnostic co-development in oncology.Experience in evaluating and auditing partners for clinical biomarker test execution.Familiarity with clinical laboratory and medical device requirements in the US and EU including: GCP/GCLP, CAP/CLIA, ISO15189, ISO13485, etc.Knowledge of US and Ex-US diagnostic testing and regulatory landscape, including evolving IVDR requirements in the EU, QSR regulations, and GMP manufacturing.Experience authoring and reviewing regulatory documents including pre-submission packets, SRD, IDE, HDE and ODD applications, 510(k) and PMA submissions for Class II and Class III devices.Able to manage multiple projects including assessment of bandwidth and resourcing requirements to deliver the team’s objectives.Track record of success working within a matrix team environment.Detail oriented with strong organization skills.Exceptional written and verbal communication skills.Proficiency with MS Office and collaboration tools such as Teams.Working arrangementThis position is hybrid. You will combine remote work with time in the office for team collaboration and critical meetings. Specific on-site expectations will be discussed during the interview process.#GSK-LI• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $150,975 to $251,625. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - View email address on apply.placed-app.com is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.Important notice to Employment businesses/ AgenciesGSK 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 the Centers for Medicare and Medicaid Services (CMS) website at SummaryLocation: USA - Massachusetts - Waltham; UK - Hertfordshire - Stevenage; USA - Pennsylvania - Upper ProvidenceType: Full time