Director, Translational Science Lead Respiratory

GSK•Upper Providence, PA

7d•Hybrid

About The Position

At 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&D Position Summary The Respiratory, Immunology and Inflammation Translational Unit (RIITU), within RIIRU therapy area is accountable for end-to-end disease area translational science to inform therapy area and program level biomarker strategies (from preclinical to launch) to increase the probability of success from preclinical to clinical transitions and enable earlier and higher confidence asset related decisions. This includes generation of foundational data as well as disease biomarker development and validation that allow timely deployment of tools/biomarkers to support Proof of Mechanism (PoM), signs of clinical efficacy, Proof of Concept (PoC), and pairing Mechanisms of Action (MoAs) with patient subtypes to predict responder populations. We are looking for a dynamic individual to excel in the following responsibilities.

Requirements

Ph.D. in a relevant scientific discipline (e.g., Cell/Molecular Biology, Genetics, Pharmacology, Physical Chemistry or related field)
Extensive experience in translational science and biomarker development ideally within the pharmaceutical or biotechnology industry.
Recognised translational/biomarker expert in scientific community through publications and contributions to the field.
Experience of translation and biomarkers implementation in Respiratory indications
Experience of working in a clinical trial setting, working as part of a clinical study and experience of authoring and oversight of clinical and regulatory documents

Nice To Haves

Knowledge of regulatory requirements, industry standards, best practices and compliance considerations in Translational Research and biomarker development and validation.
Broad knowledge in technologies and methods used in translational research.
Proven track record of program decision making through implementing biomarker strategies and delivering translational science insights in support of drug progression through clinical transition milestones.
Experience leading/managing external collaborations and evaluation of business development opportunities.
Strong management skills, with the ability to prioritize and manage multiple objectives to meet timelines while maintaining attention to detail and high-performance standards.
Excellent inclusive matrix leadership skills, with the ability to create psychological safety, inspire and motivate a team towards achieving common goals.

Responsibilities

Disease Biomarker Strategy Development and Delivery:
Partner with the Clinical Teams, Research Technologies and the Development organization with focus on Respiratory portfolio to identify, establish biomarkers for decision making throughout clinical development phases and aligned with the overall research and development goals. This will include the identification, prioritization and validation of disease relevant biomarkers, mechanistic/surrogate biomarkers, patient stratification, and differentiated response prediction, their deployment into clinical studies and interpretation of data/results.
Translational Leadership:
Provide strategic leadership contributing to deep understanding of Disease areas enabling the development and execution of translational research disease strategies to support the discovery and development of novel differentiated therapeutics including evaluation and diligence of business development opportunities.
Translational innovation:
Evaluate novel techniques and technologies (i.e. spatial transcriptomics) to inform translational initiatives, biomarker development and validation working in collaboration with platform teams and within a multi-functional matrix environment.
Identify and guide validation of human assays (cells, tissues and organs) to enhance human translation and predictive value through the application of resources such as the Human Cell Atlas, disease tissue multi-omics data and genetic resources (external or proprietary).
Cross-functional Collaboration:
Collaborate closely with cross-functional teams including the Translational, Disease Teams, Human Genetics & Genomics, biology groups, biomarker platforms, Medicine Development Teams, HBSM, data-sciences, regulatory affairs, business development and commercial to ensure seamless integration of translational research and biomarker strategies across the drug development lifecycle.
External Partnerships:
Establish and maintain strategic collaborations with academic institutions, contract research organizations (CROs), and other external partners to access cutting-edge technologies, tools, reagents, biosamples, biomarker expertise, and research capabilities.
Foster a network of external experts and key opinion leaders to stay at the forefront of translational science and biomarker advancements across the industry.
Contribute to evaluation and diligence of business development opportunities.
Matrix Leadership:
Provide mentorship, guidance, and professional development opportunities to ensure a high-performing and motivated team.
Manage disease and project level resources, budgets, and timelines to ensure the successful execution of projects and achievement of milestones and RITU objectives.
Represent RITU at portfolio governance reviews providing critical input to pipeline and investment decision making.