Associate Director - Diagnostics

GSK; Stevenage; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading global biopharma company is seeking an Associate Director - Diagnostics Oncology Translational Medicine. In this role, you'll lead the development and commercialization of diagnostics in oncology, manage projects, and ensure alignment with clinical milestones. Candidates should have a PhD or MS in biological sciences and extensive experience in clinical trial design and biomarker testing. A strong emphasis on collaboration and project management is essential.

Benefits

Comprehensive benefits program

Opportunities for professional growth

Qualifications

• 3+ years of experience in pharmaceutical and/or IVD manufacturer.
• Experience in clinical trial design and execution.
• Experience in clinical/translational biomarker investigation.

Responsibilities

• Support end-to-end diagnostic strategy development and alignment with clinical milestones.
• Accountable for development and validation of diagnostic tests.
• Manage projects within agreed timelines and budgets.

Skills

Clinical trial design

Biomarker testing

Data management

Project management

Communication skills

Education

Ph.D. in Biological sciences

M.S. with relevant experience

Tools

MS Office

Remote meeting tools (MS Teams)

Job description

Are 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 (Dx) team, you will contribute to efforts to implement GSK diagnostics strategies to support drug development, including technical, clinical, regulatory, commercial, intellectual property, and business development components. You will lead diagnostic projects and work streams according to agreed deliverables, timelines, and budgets. In this role, you will have the opportunity to lead the development and commercialization of diagnostics in Oncology.

The Associate Director will contribute to Dx development with a culture of collaboration as a member of a matrix cross-functional team.

Key responsibilities include:

• Support the development of an end-to-end diagnostic strategy within early and late-stage therapeutic clinical studies to align diagnostic development milestones with clinical development milestones and overall translational biomarker strategy.
• Accountable for tactical 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 diagnostic assays within clinical studies.
• Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation are compliant with all regulatory requirements.
• Manage and deliver projects/work streams within agreed budgets in a timely manner.
• Work within, and potentially 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, schedules of activities, and clinical study reports.
• Contribute to strategies for managing risks related to clinical study timelines, budgets, and goals, balancing risk and benefit with clear understanding of project impact.
• Build and maintain networks with clinical study teams, regulatory, clinical and biomarker leads, project management, business operations, and IVD partner joint project team members to ensure timely information dissemination and transparency.
• Provide frequent updates on diagnostic project deliverables to management and study-level matrix teams, both internally and externally.
• Collaborate with colleagues across clinical, regulatory, operations, policy, BD, and leadership within project teams.

Why You?

Basic Qualifications

• Advanced degree in Biological sciences;
• Ph.D. with 3+ years of pharmaceutical and/or IVD manufacturer experience or
• M.S. with 5+ years of relevant experience;
• Experience in clinical trial design and execution, including 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 validation requirements;
• Experience with technical platforms such as IHC, immunoassay, PCR, NGS, and novel assay technologies;
• Proficiency with MS Office 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 Dx co-development in oncology;
• Experience evaluating and auditing partners for clinical biomarker test execution;
• Familiarity with clinical laboratory and medical device regulatory requirements (GCP/GCLP, CLIA, CAP, ISO15189, QSR, GMP, ISO13485, FDA/US, EMA/EU);
• Knowledge of US and Ex-US testing and regulatory landscape, including IVDR requirements;
• Ability to manage multiple projects, assessing workload and resourcing needs;
• Attention to detail and strong organizational skills;
• Excellent written and verbal communication skills;
• Experience 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 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. We aim to positively impact the health of 2.5 billion people by the end of the decade through innovation in medicines and vaccines, focusing on respiratory, immunology, oncology, HIV, and infectious diseases.

We are committed to creating an environment where our people can thrive and focus on what matters most. Our culture is built on ambition for patients, accountability, and doing the right thing, which guides how we deliver for patients, shareholders, and our people.

If you require accommodations or assistance to apply, please contact the GSK Service Centre at 1-877-694-7547 or [phone].

GSK is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, parental status, national origin, age, disability, genetic information, military service, or other protected status.