Clinical Development Director – Renal
Location: Multiple (Stevenage, UK; London, UK; Boston, MA, USA; Collegeville, PA, USA)
Job Type: Full-Time
Category: Medical & Clinical
Job ID: 427117
About the Role
GSK is seeking an experienced and strategic Clinical Development Director – Renal to lead clinical and translational programs within the Early Pipeline Unit (EPU) of the Respiratory, Immunology, and Inflammation Research Unit (RIIRU). This role focuses on advancing renal clinical development strategies and studies, from early translational research through proof-of-mechanism and proof-of-concept trials.
The successful candidate will collaborate across functional teams, including Regulatory, Medical Affairs, Commercial, Translational Science, and Clinical Operations, to design and execute comprehensive clinical development plans that accelerate patient access to innovative therapies.
Key Responsibilities
Provide clinical and scientific leadership for renal translational and clinical development programs.
Align translational and clinical study plans with project strategies to ensure effective execution of Clinical Development Plans (CDPs).
Define clinical development pillars, including pharmacology, mechanism of action, and efficacy endpoints.
Generate and interpret data to evaluate medicine efficacy, safety, differentiation, and patient value.
Collaborate cross-functionally with Biology, Translational, Commercial, Regulatory, Clinical Operations, Access, Medical Affairs, and Statistics teams.
Design clinical development plans, study protocols, amendments, investigator brochures, and clinical study reports.
Support regulatory interactions, including submissions, briefing documents, and responses to regulatory authorities.
Provide medical monitoring and oversight of study participant safety in coordination with Pharmacovigilance teams.
Serve as a clinical lead and primary point of contact for internal and external stakeholders, including regulatory agencies and key opinion leaders.
Stay updated on renal research advancements, clinical trial methodologies, and competitive landscape to inform program strategy.
Contribute to organizational initiatives and strategic planning within the EPU.
Required Experience & Qualifications
PhD, PharmD, or equivalent with 1–3 years of postgraduate experience, or MD with relevant specialty training.
Minimum 3–5 years of experience in clinical research and development, ideally in nephrology or renal disease.
Strong knowledge of renal disease research priorities, public health needs, competitor landscape, and clinical practice trends.
Experience working with global regulatory agencies and managing multinational clinical trials.
Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.
Proven ability to work collaboratively in cross-functional, matrixed teams and influence clinical development strategy.
Preferred Qualifications
Medical degree with board certification or eligibility in Nephrology.
Experience contributing to regulatory submissions (NDA, BLA, or MAA) is preferred.
Demonstrated leadership in early clinical development programs or proof-of-concept studies.
Compensation & Benefits
Competitive base salary with annual performance-based bonus.
Flexible working options for most roles.
Comprehensive healthcare and wellbeing programs.
Learning, development, and career progression opportunities.
Employee recognition programs.
Why GSK?
At GSK, we unite science, technology, and talent to get ahead of disease together. Our mission is to improve the health of billions globally through innovative therapies and vaccines. We foster a culture of accountability, integrity, and ambition, enabling employees to thrive while making a meaningful global impact.
GSK is an Equal Opportunity Employer, ensuring all qualified applicants are considered regardless of race, color, religion, sex, gender identity, sexual orientation, parental status, national origin, age, disability, or any other protected characteristic.
SEO Keywords optimized: Clinical Development Director Renal, Nephrology clinical trials, renal translational research, GSK clinical leadership jobs, global renal drug development.
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