Overview
The Clinical Development Director - Renal provides clinical and scientific insights and leadership to clinical and translational studies or programs within the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). The appointed individual will work within project teams to plan, execute, and deliver activities including renal translational and clinical development strategies and clinical studies. You will work cross-functionally to develop and execute clinical development plans up to, and including, proof of mechanism/proof of concept studies. This role offers the opportunity to lead key activities to progress your career.
Responsibilities
* Support alignment of translational and clinical plans and study designs with project strategies to ensure quality execution of IEP and CDP. Develop sections of core regulatory documents.
* Generate the data and evidence required to determine a target or medicines’ potential efficacy, safety profile, key areas of product differentiation, and the 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.
* Seek and maintain relationships with program counterparts in Biology, Translational, Regulatory, Clinical Operations, Access, Medical Affairs and Statistics.
* Contribute to the implementation and embedding of strategic initiatives and organizational initiatives in Clinical Development.
* Provide effective support and oversight of R&D evidence generation activities to assure patient safety and study delivery.
* Contribute to study team discussions on indication planning, incorporating input from across disciplines to contribute to deliverables including early Medicine Profile, Target Validation, Translational Plans, Candidate Selection.
* Design clinical development plans and study protocols across all phases of development, reflecting stakeholder input (patients, evidence generation, regulators, payors, pharmacovigilance).
* Develop clinical study protocols, amendments, investigator brochures, and clinical study reports.
* Provide inputs to regulatory interactions and documents including briefing documents 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. If physician, accountability for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects.
* Accountable for leading the Clinical Management Team (CMT) on an EPU program and serves as a clinical point of contact for an asset indication or clinical study. Represents the clinical matrix team at EDT or clinical study governance.
* Collaborate with cross-functional teams to ensure cohesive and comprehensive translational and clinical development plans. Act as Clinical Lead at the study level.
* Lead end-to-end clinical development strategy for an EPU program and may contribute to later stages. Serve as primary point of contact for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators.
* Serve as the primary clinical interface with RIIRU/GSK governance structures and protocol review processes.
* Assess clinical evaluation of business development opportunities.
* Stay informed of renal research advancements, trial methodologies, regulatory space, and competitive landscape to maintain GSK’s competitive edge and identify transformational opportunities.
* Gather and integrate inputs from scientific, clinical, commercial, regulatory, and statistics teams to contribute to clinical components of the Medicine Profile and help solve study and development challenges.
* Contribute to strategic and organizational initiatives within the EPU.
* Demonstrate ability to influence others at project, departmental and inter-departmental levels and act as a leader in influencing and inspiring teams.
* Able to inspire others, communicate a clear vision, and foster an environment where team members are valued and motivated.
Qualifications
* PhD or PharmD (or equivalent) with 1-3 years postgrad experience in relevant training or job.
* Minimum of 3 years of experience in clinical research and development (may include postgrad experience).
* Robust knowledge of renal-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution.
* Experience working with global regulatory agencies and managing global clinical trials in nephrology.
* Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.
* Demonstrated ability to work collaboratively in cross-functional teams and a matrix environment to design and execute trials to regulatory standards.
Preferred Qualifications
* Medical Degree and Board certified/eligible in Nephrology (plus).
* Experience contributing to NDA, BLA, or MAA submissions preferred.
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
Why GSK? 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. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We are committed to creating an environment where our people can thrive and focus on what matters most, with a culture of ambition for patients, accountability for impact and doing the right thing. GSK is an Equal Opportunity Employer and is an agile working organization. For US-based interactions, some expense reporting may be required per transparency requirements. For more information, visit CMS Open Payments.
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