Medical Director Clinical Development- Nephrology

About this role

For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

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

We are seeking an experienced Medical Director Clinical Development- Nephrology to join GSK’s Respiratory, Immunology & Inflammation Research Unit. In addition to providing clinical and scientific leadership to clinical and translational studies or programs for asset-level projects, you will contribute to the assessment of potential mechanisms and targets, target validation programs, life-cycle expansion and innovative clinical development opportunities. You will work cross-functionally to develop and execute clinical development plans (CDPs) and contribute to above-project development of foundational and real-world data, and translational and biomarker capabilities, within a department that prioritizes understanding mechanism and unmet need alongside innovative clinical development, helping us deliver differentiated medicines that change the course of disease and improve patients’ lives.

In the Respiratory, Immunology, and Inflammation Research Unit (RIIRU) , our enduring purpose is to leverage immune science to address underlying organ dysfunction and disease. We are trailblazing a pipeline of medicines to dramatically improve how we cure and care for patients. We are a diverse team of industry-leading experts who channel our passion for scientific exploration into true value for patients and GSK. We drive the end-to-end R&D journey, fueling early discovery and our mid-stage pipeline while also advancing our late-stage medicines to launch. We are combining field-leading data sets, capabilities and methods with decades of knowledge, to transform our success in how we innovate new medicines.

Working model: This role is hybrid. You will be on-site at one of the posted locations at least two days per week. Remote work is available on other days.

Position Summary: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • Support alignment of translational and clinical plans and study designs with project strategies to ensure quality design and execution of the CDP. Develop sections of core regulatory documents.

• Generate the data and evidence required to determine a target’s potential efficacy, safety profile, key areas of differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe.

• Define and deliver the clinical pillars of the translational table.

• Deliver clinical development and study timelines and endpoints, including pharmacology, mechanism and clinical efficacy endpoints, enabling key decision points and Go/No Go criteria for the CDP

• Establish and maintain relationships with program counterparts in Biology, Translational Sciences, Commercial, Regulatory, Clinical Operations, Market Access, Medical Affairs and Statistics.

• Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development.

Clinical Development Strategy and Study & Program Design • Provide effective support and oversight of R&D evidence generation strategy, plan and activities to ensure patient safety and on-time, in-full study delivery. Contribute to the study team discussions on indication planning and incorporate input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc.) to contribute to vital deliverables including early medicine profile, target validation, translational plans, candidate selection.

• Design clinical development plans, study protocols and associated documents across all phases of development, reflecting internal and external stakeholder input (e.g., patients, evidence generation, regulators, payors, pharmacovigilance).

• Bring clinical expertise to regulatory interactions and documents including briefing documents, presentations, addressing questions and responses for assigned studies and programs.

• Provide medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study, together with Pharmacovigilance Physician.

• Accountable for medical governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.

Clinical Leadership • Accountable for leading the Clinical Matrix Team (CMT) for a program. Serves as a clinical point of contact both internally and externally for an indication of an asset or for a clinical study. Represents the CMT at Early/Medicine Development Teams or clinical study at CMT.

• Actively leads the end-to-end clinical development strategy for an early program and may contribute to later stages.

• Serve as the primary Clinical point of contact for an investigational agent (early development) or clinical study for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators and with the relevant internal review boards (e.g., Technical Revie

Similar jobs

• Clinical Development Medical Director-Nephrology — Vertex · Boston, MA
• Clinical Development Director- Nephrology — GSK · Boston, Massachusetts, United States | Stevenage | London, UK
• Medical Director, Clinical Development — Dynetherapeutics · Waltham, MA
• Senior Medical Director, Clinical Development — Spyretherapeutics · Remote
• Senior Director - US Medical Affairs - Nephrology — Vertex · Boston, MA
• Medical Director Pediatric Nephrology — MultiCare · Tacoma, Washington
• Senior Director, Clinical Development — Bridgebio · San Francisco - 1800 Owens
• Senior Director, Clinical Development — Annexonbioscience · San Francisco Bay Area