We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

As a global leader treating pulmonary disease, we are now seeking a Clinical Development Director for emerging respiratory indications. This role will offer the opportunity to lead key activities in this therapeutic area at GSK.

Key Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Contributing and supporting the clinical development of novel assets  to treat pulmonary diseases.
• Driving cross-functional teams ensuring alignment with clinical development plans (CDP) towards market authorization.
• Contributing leader of generating data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible time frame
• Contributing leader for clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP
• Developing and maintaining relationships with cross-functional stakeholders in Research and Early Development, Regulatory, Clinical Operations and Statistics.
• Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development
• Actively contributing or leading the end-to-end clinical development strategy for a drug or program. Manages specific clinical development plans for product(s) and/or indication(s) in assigned therapy disease area
• Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset in development
• Interfacing with a diverse range of scientific external experts (e.g. regulators, payors, CROs, disease area experts, clinical study investigators) in order to deliver state-of-the-art expertise and clinical programs and align to business strategy and address patient needs
• Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches
• Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses
• Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• MD and/or MD/PhD with board certification (or equivalent) either in Pulmonary Medicine, Internal Medicine or Critical Care Medicine
• Experience in advanced data analytics in clinical research/development
• Experience utilizing statistics and visualisation techniques to interpret or analyse complex information to facilitate decision making

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance
• Experiences with data visualization and analytics software
• Solid understanding of respiratory clinical drug development with an understanding of the disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options
• Significant clinical training and/or applicable clinical research and development experience
• Robust knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area
• Demonstrated experience using new learning and digital tools to create innovation in other areas
• Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules
• Demonstrated experience integrating genetic data to inform and guide clinical protocols

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