Latest regulatory affairs Jobs

Medical Director, ViiV Healthcare

The Medical Director role at ViiV Healthcare involves managing and reporting data from Phase 1-4 clinical trials, contributing to the design and medical governance of studies, and providing medical expertise and support throughout the trial process. The role is crucial in advancing HIV treatments and working closely with internal and external stakeholders to ensure the success of clinical studies.

GSK

On-site Permanent

Director, Translational Science Lead

This role leads translational science strategy across renal, inflammation, fibrosis, and neurodegeneration disease areas, driving biomarker development and validation to support clinical decision-making from preclinical through to launch. The position integrates cutting-edge technologies like spatial transcriptomics and human multi-omics data, working across discovery and development to de-risk clinical transitions and identify responder populations.

GSK Stevenage, United Kingdom US$178,200 – US$297,000 pa

Hybrid Permanent

Global Development Lead, Internal Medicine, Sr. Director (MD)

The Global Development Lead (GDL) is responsible for leading the clinical development of assigned assets in Internal Medicine. This involves designing, executing, and interpreting clinical studies, creating development plans, and collaborating with cross-functional teams to ensure regulatory approvals and global market access. The role also includes specialized monitoring, regulatory submissions, and engaging with external stakeholders to drive strategic insights.

Pfizer

On-site Permanent

Global Development Lead, Internal Medicine, Sr. Director (MD)

The Global Development Lead (GDL) is responsible for leading the clinical development of assigned assets in Internal Medicine, working closely with cross-functional teams to design, execute, and interpret clinical studies. Key responsibilities include creating clinical development plans, regulatory submissions, and providing expert input on trial design and execution, while ensuring compliance and strategic insight generation.

Pfizer

On-site Permanent

Senior Clinical Development Medical Director - Renal

The Senior Clinical Development Medical Director will lead the strategy and execution of renal clinical development programs, from early to late phases. Responsibilities include providing clinical leadership, developing regulatory documents, ensuring patient safety, and collaborating with global teams and stakeholders.

Novartis

On-site Permanent

Senior Principal Biostatistician

This role involves leading the implementation of innovative trial designs and statistical models, collaborating with clinical and regulatory teams, and contributing to exploratory analyses and statistical consultations. The position requires a strong background in biostatistics and the ability to drive quantitative decision-making in clinical trials.

Novartis London, United Kingdom

Hybrid Permanent

Associate Director, Operations Excellence Supported Studies

This role focuses on strengthening the operational and data foundations for Supported Studies at GSK, ensuring data integrity, system performance, and compliance. The Associate Director will lead digital integration, dashboard governance, and process improvements, acting as a bridge between business and technology teams to enhance efficiency and regulatory adherence in clinical operations.

GSK United States US$154,275 – US$257,125 pa

Hybrid Permanent

Associate Director, Operations Excellence Supported Studies

This role leads operational excellence for Supported Studies at GSK, focusing on data integrity, system governance, and digital transformation. The individual will own the data and dashboard ecosystem, act as Business System Owner for key platforms like IdeaPoint and Veeva, and ensure compliance with regulatory requirements such as Transfer of Value. They will bridge business and technology to drive process improvements, enable resource planning, and enhance data transparency across clinical operations.

GSK £154,275 – £257,125 pa

Hybrid Permanent

Associate Director, Operations Excellence Supported Studies

This role focuses on strengthening the operational and digital foundations of GSK's Supported Studies program. The Associate Director will lead data governance, system ownership, and digital integration efforts, ensuring data integrity, compliance, and efficiency across platforms like Veeva and IdeaPoint. The position acts as a bridge between business and technology, driving process improvements and digital transformation in a regulated clinical environment.

GSK US$154,275 – US$257,125 pa

Hybrid Permanent

Associate Director, Operations Excellence Supported Studies

This role leads the operational and digital foundations for Supported Studies at GSK, ensuring data integrity, system performance, and compliance across platforms like Veeva and IdeaPoint. The individual will drive process improvements, support regulatory reporting such as Transfer of Value, and act as a bridge between business and technology teams to enhance efficiency and scalability in clinical operations.

GSK US$154,275 – US$257,125 pa

Hybrid Permanent

ViiV Healthcare (GSK) Director, Clinical Pharmacology

This role involves leading clinical pharmacology strategy across HIV drug development programs, applying PK/PD and pharmacometric modeling to inform study design, regulatory decisions, and development pathways. The Director will mentor project leads, collaborate with cross-functional teams, and serve as a scientific expert in modeling and simulation to advance ViiV’s mission-driven HIV research from early to late-stage development.

GSK United States

Hybrid Permanent

ViiV Healthcare (GSK) Director, Clinical Pharmacology

This role involves providing scientific leadership in clinical pharmacology to shape drug development programs for HIV treatments. The Director will apply PK/PD, pharmacometrics, and model-informed drug development approaches to guide study design, regulatory strategy, and key decisions across early to late-stage development. Collaboration with cross-functional teams including clinical, regulatory, biostatistics, and CMC is central to advancing innovative therapies in a mission-driven environment focused on eradicating HIV.

GSK

Hybrid Permanent

ViiV Healthcare (GSK) Director, Clinical Pharmacology

This role involves leading clinical pharmacology strategy across HIV drug development programs, applying PK/PD, pharmacometrics, and modeling to inform study design, regulatory decisions, and development pathways. The Director will mentor project leads, collaborate with cross-functional teams, and serve as a scientific expert in model-informed drug development, contributing to breakthroughs in HIV treatment and prevention.

GSK

Hybrid Permanent

Associate Director- Diagnostics Precision Medicine

This role involves leading diagnostic strategies in oncology drug development, focusing on end-to-end execution of biomarker-driven clinical trials. The individual will oversee assay development and validation, manage cross-functional teams, and ensure regulatory compliance across global studies. Collaboration with IVD partners and integration of advanced diagnostic technologies like NGS and liquid biopsy are key components of the position.

GSK United States £150,975 – £251,625 pa

Hybrid Permanent

Associate Director- Diagnostics Precision Medicine

This role involves leading diagnostic strategy and project execution in oncology translational medicine, supporting drug development through biomarker-driven clinical studies. The individual will oversee assay development and validation, ensure regulatory compliance, and collaborate across cross-functional teams and external partners. It emphasizes end-to-end ownership of diagnostic initiatives within a global biopharma R&D environment.

GSK £150,975 – £251,625 pa

Hybrid Permanent