Clinical Development Director Respiratory
1 month ago
Posted Date: Aug 1 2024
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
Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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