Clinical Development Director, Gastroenterology, Open to flexible working
2 days left
- Contract Type
Within our Clinical Sciences organisation, we are relentless in delivering extraordinary impact for patients, and making GSK a brilliant place to work.
We're seeking a Clinical Development Director (Gastroenterology) to contribute to our Phase 2 development program for the treatment of celiac disease. In this role, you will support the Clinical Development Lead (CDL) and clinical team to develop and deliver the clinical program and for an oral inhibitor of transglutaminase 2 for celiac disease, as well as overall life cycle management plans.
Job purpose and key responsibilities:
- 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
- Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery
- Contributing to regulatory interactions including clinical trial applications, briefing documents, presentations, addressing questions and responses
- Contributing to the writing of the clinical study synopsis (CSP), study protocols, clinical study reports (CSR) and any subsequent study abstract and manuscript publications
- 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
- Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP
- Developing and maintaining relationships with matrix counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
- 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) in order to deliver clinical programs and align to business strategy and address patient needs
- Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Sciences
- Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches
- Bachelor’s degree in a science related field
- Significant 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, GCP, FDA requirements, regulatory and reimbursement data requirements in responsible area
- Solid understanding of needs and priorities of regulators, payers and prescribers in relevant market(s)
- 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
- Proven ability to utilize statistics, and visualisation techniques to interpret or analyse complex information and make correct inferences and conclusions.
- MD, PhD or PharmD degree valuable but not required
- Experience leading matrix teams with a strong reputation of inspiring and motivating high performance
- Previous experience as a Clinical science Lead (CSL) at GSK, or a similar position in another company
- Significant experience in gastroenterology clinical drug development with an understanding of the disease area, the underlying biology and potential therapeutic targets as well as current and future potential treatment options, in particular celiac disease, but also gastroenterology more broadly.
Closing date for applications: 31 January 2022
We prevent and treat disease with vaccines and specialty and general medicines. We focus on the science of the immune system, human genetics, and advanced technologies, investing in four core therapeutic areas (Infectious Disease, HIV, Oncology, and Immunology/ Respiratory) and future opportunities to impact health at scale. Our pipeline currently comprises 57 vaccines and medicines, predominantly in infectious diseases, oncology, and immune-mediated diseases.
We operate by the multiplier effect of Science x Technology x Culture. This approach helps us accelerate the pace at which we develop and deliver transformational medicines, prioritising those molecules with a higher probability of success and terminating less promising programmes.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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