Director, Translational Science Lead

GSK•Upper Providence, PA

2d•$178,200 - $297,000•Hybrid

About The Position

The Director, Translational Science Lead Renal, Inflammation and Fibrosis and Neurodegeneration Translational Sciences (TS), within the Respiratory, Immunology and Inflammation Research Unit (RIIRU) therapy area is accountable for end-to-end disease area translational science. This role informs 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 the 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.

Requirements

Ph.D. in a relevant scientific discipline (e.g., Cell/Molecular Biology, Genetics, Pharmacology, Physical Chemistry or related field)
Associate Director or Director-level experience in translational science and biomarker development within the pharmaceutical or biotechnology industry.
Recognized translational/biomarker expert in the scientific community through publications and contributions to the field.
Higher education or experience in translation and biomarkers implementation in Renal, Inflammation and / or Fibrotic 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.
Working knowledge of regulatory requirements, industry standards, best practices, and compliance considerations in Translational Research and biomarker development and validation.
Broad knowledge and experience 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.

Nice To Haves

Awareness of bioinformatic / computational methods supporting integrated analysis and interpretation of translational and biomarker-related data sets.
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.
Ability to adapt to a fast-paced and evolving research environment, with strong problem-solving and critical-thinking skills.

Responsibilities

Partner with Clinical Teams, Research Technologies, and the Development organization to identify and establish biomarkers for decision-making throughout clinical development phases, aligned with overall research and development goals. This includes 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.
Provide strategic leadership contributing to a 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.
Evaluate novel techniques and technologies (e.g., 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 the 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).
Collaborate closely with cross-functional teams including 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.
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 the evaluation and diligence of business development opportunities.
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 TS objectives.
Represent TS at portfolio governance reviews, providing critical input to pipeline and investment decision-making.