Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK – London – New Oxford Street, USA - Massachusetts - Waltham
Posted Date: Feb 4 2025
Are you driven by the opportunity to lead clinical and scientific initiatives for new and established rheumatology treatments and collaborate across early stages of development and beyond? If so, the Senior Medical Director, Rheumatology role could be an exciting opportunity to explore.
A Senior Medical Director, Rheumatology is sought to provide clinical and scientific leadership for potential new, established, and emerging indications for a late stage, assets in the rheumatology portfolio. The Senior Medical Director, Rheumatology will work with project teams to plan and assure delivery of clinical research and development activities. Additionally, you will work with early development teams to plan clinical development programs and establish efficient collaboration throughout all stages of development.
This career opportunity requires an on-site office presence (minimum of two days a week) in one of GSK’s US(PA or MA) or UK (Stevenage or London – New Oxford Street) sites.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
* Lead the end-to-end clinical development strategy for a drug or program. Manage specific clinical development plans for product(s) and/or indication(s) in specific therapy/disease areas.
* Contribute to the strategic management of the Integrated Evidence Plan (IEP), including oversight of the Clinical Development Plan (CDP) and its component clinical trials for an asset in development. Be accountable for the clinical components of the Target Medicine Profile (TMP).
* Provide strategic leadership, for example in assuring that the clinical study designs are aligned with the IEP and CDP, and consider the scientific rationale, regulatory requirements, product development plan and commercial goals.
* Establish and deliver to clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP.
* Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
* Serve as a clinical point of contact for senior management and senior level matrix teams.
* Contribute to Business Development activities, including due diligence projects.
* Interface with and influence a range of scientific external experts (e.g., regulators, payors, CROs, consultants, investigators) to deliver clinical programs that align to business strategy and address patient needs.
* Lead and be accountable for the evaluation of the probability of technical success (PTS) of clinical studies/programs.
* Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients.
* Assess risk/benefit at the study and/or project level. Take action to mitigate risk where appropriate.
* Make substantial contributions to global regulatory interactions and files, including briefing documents, presentations, submission documents, and responses to questions.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
* Medical degree with specialist training in rheumatology
* Experience in (bio-)pharmaceutical industry in clinical drug development.
* Experience with planning clinical development for a rheumatology asset and/or indication.
* Record of delivery of clinical trials and projects in the rheumatology clinical science space.
* Experience of global regulatory filings/submission
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
* Medical degree with specialist training in rheumatology and PhD
* Experience of clinical research methodology and principles of biostatistics to facilitate innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules.
* Thorough understanding of rheumatology diseases, underlying biology, and potential therapeutic targets
* Robust knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements
* Solid understanding of needs and priorities of regulators, payers, and prescribers in relevant global market(s)
* Experience collaborating with multiple stakeholders on complex projects.
* Record of building and maintaining strong relationships with internal and external stakeholders
* Line/matrix management experience including also coaching, mentoring and development, with a record of inspiring and motivating high-performance team.
Why GSK?
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.
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