Training Director - Stevenage, Hertfordshire, United Kingdom - GlaxoSmithKline

Description

Director, Clinical Research and Early Programmes Immunology page is loaded Director, Clinical Research and Early Programmes Immunology

Apply locations UK - Hertfordshire - Stevenage UK - London - Brentford time type Full time posted on Posted Yesterday job requisition id A Director, Clinical Research and Early Programmes Immunology is sought to provide clinical and scientific insights to the immunology franchise including emerging indications and adjacencies .

You will work with in project teams to plan and assure delivery of clinical research and development activities.

You will work with early and late development teams to plan clinical development programs and facilitate close collaboration between different groups within the Respiratory & Inflammation Research Unit.

The responsibilities of the Director Clinical Research and Early Programmes Immunology include (but are not limited to) several key areas:

designing and leading , as appropriate , clinical development protocols / studies/ programs in Immunology across all phases of development , as required by business imperatives as part of clinical and medicine development matrix teams.

providing clinical expert input into regulatory documentation and leading regu latory interactions from clinical perspective for their studies/ indications, as appropriate

working closely with R esearch Unit members to define prioritised clinical indication s for early target s and integrate inputs from across disciplines (scientific, clinical , commercial, regulatory and stats ) to contribute to the Medicine Profile, Target Validation , Translational Plans , Candidate Selection .

, And/or accountability for design and delivery of the full development clinical development plan that effectively demonstrates benefit-risk and leads to a successful submission to regulators, payors etc
accountability for leading the integrated evidence planning to address the needs of regulators, payors and patients
a ccounta bility for engaging external academic and clinical experts to enhance quality and delivery of clinical programmes / studies
a ccountab ility, if medically qualified , for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across all studies and other GSK activities/functions impacting safety and efficacy ( i.e., a ccountab ility, if medically qualified , for providing medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study and, together with the Safety Pharmacovigilance Physician, providing input into aspects of study design that relate to subject safety
a ccountab ility for escalation of clinical safety incidents to the Immunology Clinical Research and Early Programs Head and GSK Pharmacovigilance, as appropriate
accountability for clinical input to regulatory documentation to support the desired indication (e.g., responsibility for addressing clinical questions at meetings with regulatory authorities/ethics committees
a ccountab ility for regulatory reporting requirements including Development Safety Update Reports (DSUR's) and IB updates
a ccountab ility for incorporating patient perspective in the design and conduct of clinical studies
You will be expected to work across multiple projects and be independently accountable for your own projects
You will be expected to input into disease area strategy and be capable of executing this strategy based on your own expertise and that gained from your network
You will play a leadership role in – medical governance initiatives in R&D ( e.g., safety panel or governance board) – discovery/development policy, processes or guid elines, as requested by the business – or in professional networks in/outside of GSK
You will be able to be mentoring and coaching other members of Clinical Research and Early Programmes Immunology – applying extensive knowledge of clinical development to more than one research unit/disease area
You will be able to build an external network with academia/pharma, bringing expertise back to GSK
Doctor of Medicine OR ' MD, PhD ' OR PhD with industr y experience
S ignificant proven clinical or scientific e xpertise in rheumatology/dermatology/immunology
Specialty training in rheumatology /dermatology/ immunology area, in particular lupus and adjacencies , would be a dvantageous
e xperience of setting and executing scientific strategy, whilst being mindful of overall company goals
Experience in working with relevant regulatory bodies and professionals in early / late stage discovery and development
Project Management

Demonstrates the discipline of risk-based planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics.

At GSK HQ, we're building an energising space where we can connect, collaborate and get ahead of disease together.

Designed especially for us, it'll be one of the healthiest workplaces in the world, with best-in-class tech and bright, light spaces to help us thrive.

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).

This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, 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.

.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.

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