Clinical Development Director-Respitory

GSK places the patient at the heart of everything we do and as leaders in respiratory disease, we are committed to improving the lives of those living with asthma, COPD, eosinophilic driven diseases, and other respiratory-related illnesses.

We are constantly striving to expand knowledge and the understanding of respiratory disease and other eosinophilic driven diseases to help revolutionize the way that medicines are developed. Taking an opportunistic approach, we are focused on first-in-class biologics, developing best-in-disease medicines and devices for patients.

We're seeking a Clinical Development Director to lead phase 2A studies through to registrational programs for emerging indications within the Respiratory Clinical Sciences group. Join our dynamic & collaborative community of clinical development physicians and scientists, as we shape and build our strategy across the respiratory organization, driving scientific innovation to deliver the next generation of transformational medicine for patients.

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

•Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development.

•Ensuring alignment with and support to project strategic plans, regulatory requirements, and commercial goals, optimizing clinical study design aligned with IEP and CDP.

•Generating the 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 timeframe.

•Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP.

•Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.

•Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development.

•Supporting technical and leadership development of Clinical Sciences staff via mentoring and coaching for matrix team members.

•Actively managing and contributing to 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 and influencing a diverse range of scientific external experts (e.g., regulators, payors, CROs, consultants, investigators) to deliver clinical programs and align to business strategy and address patient needs.

•Gathering and supporting the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile.

•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:

· Bachelor of Science.

· Minimum 3 years' experience with Clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.

· 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.

· 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.

· Proven ability to utilize statistics, and visualization techniques to interpret or analyze complex information and make correct inferences and conclusions.

Preferred Qualifications:

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

· MSc, PhD, PharmD or MD preferred.

· Deep understanding of respiratory disease and other eosinophilic driven diseases. and the underlying biology and potential therapeutic targets.

Why GSK?

We're uniting science, technology and talent to make a difference in more people's lives, and revolutionizing the way we do R&D.

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.

No single scientist, nor any one technology can keep us all ahead of disease. That's why we build important collaborations with commercial and academic partners to advance our understanding of disease and what it takes to get ahead. In the past three years, we've doubled the number of partnerships we've signed, because of our belief in their significant impact on our process.

Our pipeline currently comprises of more than 60vaccines and medicines across four core therapeutic areas including infectious diseases, HIV, oncology and immunology as well at pursuing other science-led opportunities outside our core areas. Many have the potential to be first or best-in-class opportunities for patients and since 2017, we've delivered 13 major approvals and more than doubled the number of potential new vaccines and medicines in Phase 3 and registration to 23.

#LI-GSK

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