Cardiovascular Clinical Development Director

Regulatory Jobs; Waltham (MA); Hybrid; USD 161,000 - 241,000; Full time

Job summary

GSK is seeking a Medical Director in Cardiovascular within the Respiratory, Immunology & Inflammation Research Unit. The role involves leading clinical development plans, providing oversight of study designs, and ensuring patient safety across translational programs.

You will work cross-functionally with Biology, Regulatory, and Commercial teams and contribute to regulatory communications. The position is hybrid, with on-site presence required at Stevenage and relocation plans toward Cambridge.

Qualifications

• Lead clinical development plans across all phases.
• Provide medical governance and safety oversight of studies.
• Collaborate with Biology, Translational Sciences, Commercial, Regulatory, Statistics.
• Present to regulatory agencies and review boards.

Responsibilities

• 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.
• Design clinical development plans, study protocols, and associated documents across all phases of development.
• Bring clinical expertise to regulatory interactions and documents including briefing documents and responses.
• Provide medical monitoring and oversight of safety of study participants during the study.
• Accountable for medical governance across the project to ensure scientific integrity and safety.

Skills

Clinical leadership

Regulatory interactions

Study design

Cross-functional collaboration

Job description

GSK is seeking a Medical Director in Cardiovascular within the Respiratory, Immunology & Inflammation Research Unit. The role involves leading clinical development plans, providing oversight of study designs, and ensuring patient safety across translational programs.

You will work cross-functionally with Biology, Regulatory, and Commercial teams and contribute to regulatory communications. The position is hybrid, with on-site presence required at Stevenage and relocation plans toward Cambridge.