Senior Director, Head of Diagnostic Execution

The Diagnostic (Dx) Delivery Team within Oncology Translational Medicine (OTM) is a dedicated group of scientific operations professionals that drive the implementation of clinical diagnostic strategy for therapeutic programs in early and late-stage Oncology clinical development. The Dx Delivery Team leverages subject matter expertise to progress Dx activities and deliverables in collaboration with Diagnostic (Dx) strategy leads Clinical Biomarkers (BMx) Precision Medicine & Digital Health Regulatory Clinical Operations Human Biological Sample Management Data Management Quality Procurement and Finance as well as external CRO laboratories central laboratories collaborators and Dx manufacturers. The team oversees implementation of clinical trial assays at reference labs and centralized testing vendors through contract execution and vendor oversight ensures integration of relevant Dx content in clinical study documents and associated systems (i.e. clinical protocol informed consent forms eCRFs CSRs etc.) manages HBS and logistics to support the clinical trial schedule ensures data is ready for analysis per timeline and oversees data transfer and resolves or escalates Dx study-related issues.

The Head of Diagnostic Execution is accountable for leading this highly skilled technical team of Dx Delivery professionals with responsibility for line management training oversight and retention ensuring the team is resourced and trained to manage their accountabilities addition the successful candidate will be experienced in facilitating therapeutic product and/or Dx co-development project management scenario planning budgeting HBS management and managing external vendors and partners. This role is also responsible for optimizing processes developing and communicating strategy ensuring audit readiness and ensuring overall operational excellence for the Translational Medicine Team.

KEY RESPONSIBILITIES:

• Lead a team of diagnostic operations professionals to implement clinical biomarker and diagnostic plans for therapeutic programs in early and late-stage clinical development
• Line management training oversight and retention of diagnostic operations professionals

• Maintain knowledge of the science technology portfolio and strategy of R&D across Oncology and deliver high-quality diagnostic operations support
• Engage with and influence leaders and cross-functional stakeholders to develop diagnostic operational strategies by leveraging broad knowledge of biomarker technologies diagnostic development IVD expertise and global diagnostic regulatory requirements
• Serve as a key strategic liaison with stakeholders across Clinical Operations Central HBSM Biobank Data Management Procurement Regulatory and Quality Assurance; work to improve cross-functional processes across GSK
• Contribute to the continued building of a framework within the Operations function focusing on growth and development of new and innovative ways to work with internal and external partners
• Lead functional process and system improvements to ensure operational excellence
• Proactively support developing and reviewing standard processes and templates
• Apply and adhere to ICH/GCP HBS management best practices regulatory guidelines ethical guidelines and technical and industry standards during all aspects of work ensuring inspection readiness by ensuring preparedness and compliance; support team members in connection with inspections and audits
• Represent the Dx Planning & Execution department internally and externally in meetings and discussions as required and ensure representation of the Dx Delivery team during cross-functional workstreams

• Set a positive and motivating work environment that encourages mutual respect innovation and accountability at all levels by role modelling the GSK values

BASIC QUALIFICATIONS:

• MS or PhD degree in biological sciences or related discipline
• Minimum of 10 years of experience in the diagnostic pharmaceutical or biotech industry
• 5 years managing an Operations team
• Strong background in Oncology
• Experience with drug discovery and development clinical trial design and principles of clinical development
• Experience in strategic set-up of central laboratory operations study start up clinical sample tracking/reconciliation and analysis
• Experience in discovery development outsourcing and validation of clinically applicable BMx and Dx assays including clinical validation and global diagnostic regulatory submissions requirements

Expertise & skills:

• Experience in clinical trial specimen management including collection/processing of diverse sample types LIMS laboratory management and oversight and global regulatory requirements and expectations for sample analysis including sample exportation
• Proven track record of independent contributions to a strategic transformation of operations
• Demonstration of successful coaching/mentoring and direct people management skills
• Proven success leading teams fostering team productivity and cohesiveness and working collaboratively in a cross-functional environment
• Ability to thrive in a matrix environment and to interact effectively across boundaries using influencing & relationship building skills
• Experience in developing and implementing agile creative solutions helping to solve business challenges within the organization and in partnership with external collaborators
• Highly effective communication (verbal written and presentation) and interpersonal skills
• Established expertise and hands-on experience with MS Office applications (Word Excel PowerPoint) Outlook SharePoint remote meeting tools such as MS Teams WebEx etc. and a working understanding of innovative AI technologies (e.g. CoPilot ChatGPT GiGi Jules PowerBI etc.)

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 were 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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at where you can also request a call.

Please note should your inquiry not relate to adjustments we will not be able to support you through these channels. However we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

GSK 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/ 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 GSKs 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 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 GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:

Exec