- Permanent, Full Time
- Closes 29th June 2018
- Requisition ID: WD160858
- Required degrees: MD Degree
You will be a critical resource within the Respiratory Therapy Area Unit comprising physicians and scientists delivering novel and transformational medicines to treat respiratory conditions. We now need to expand our development capability to take forward innovative clinical strategies for therapies coming through our pipeline.
Joining our clinical development and medical monitoring teams, you will be accountable for the provision of globally integrated Medical Governance of a Clinical Trial to ensure all trends and events are fully adjudicated, to maximize current and future understanding of the benefit: risk profile of the asset in development or marketed product.
At Director level, you will lead the ongoing study data review plan for the trial, ensuring consistent Medical Governance for the study and lead the further investigation of any SAEs or identified safety trends with a goal of full adjudication of the event/trend, to inform both individual subject safety and future understanding of the medicine.
The role will require strong clinical and leadership skills and there will be the opportunity for the successful candidate to further develop individual experience and exposure from translational medicine to late stage clinical development as appropriate.
You will be accountable for:
• Providing Clinical Oversight for an asset in development or a marketed product
• Providing Medical Governance for an asset in development or a marketed product with specific accountability for governance of clinical practice and a global viewpoint of safety and efficacy, working the Project Physician Leader accountable for the overall Medical Governance across the global program, the Safety Development Leader accountable for Pharmacovigilance and the Global Medical Leader accountable for Medical Information and Promotional Practice
• Working with individual sites and investigators to capture important information related to subject clinical trial safety including adverse events, (AEs) serious adverse events (SAEs) and report this as necessary to the appropriate pharmacovigilance representative
• Work in matrix environment for all of the above, partnering with the Project Physician Leader (PPL), Medicine Development Leader (MDL) or Early Development Leader (EDL), for an asset in development or the Therapeutic Area portfolio owner or TACL (Therapy Area Clinical Lead) for a marketed product
In particular, you will be demonstrating leadership in the following areas:
• Clinical Development Expertise – understanding of the required steps to progress a new chemical lead through the stages necessary to allow it to be tested in human clinical trials
• Good Clinical Practice Knowledge - ability to ensure an investigation is conducted according to applicable Good Clinical Practice regulations and internal control documents, to protect the rights, safety, and well-being of subjects and the accuracy and validity of the trial data. You will ensure the study is in a continuous state of inspection readiness
• Clinical Judgment – ability to effectively apply medical expertise to make good clinical decisions, in accordance with appropriate SOP(s)
• Scientific & Medical Knowledge - current, in-depth understanding of the relevant drug and associated therapeutic and disease area
• Clinical Data Stewardship – understanding of the critical importance of rigorous data generation and disciplined stewardship of the data
• Medical Monitoring / Pharmacovigilance – understanding of the detection, investigation, assessment and prevention of adverse effects of medicines on patients. Knows when to involve the Safety Development Leader for escalation e.g., to the Chief Medical Officer, Global Safety Board
• Scientific Writing - ability to produce written scientific communications with clarity, accuracy and rigour and in compliance with GSK control documents governing disclosure, publication and principles of scientific exchange
• Scientific Presentation – ability to communicate effectively through formal presentation and through informal scientific discussion with credibility, accuracy, and confidence with internal and external stakeholders and experts.
• Business Acumen - understanding the implications of decisions related to human, financial, material and information resources, from a business perspective and uses this knowledge to plan, implement and manage clinical research within R&D
• Strategic Thinking – maintaining competitive advantage by ensuring the application of the principles, tools and systems from Simplifying Clinical Development
• Project Management – demonstrating the discipline of risk-based planning, organising and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time based metrics
• Line Management – the role may involve line management of clinicians or scientists within the Therapy Area.
Alignment with GSK’s vision to become the most Innovative, best performing and most trusted Pharmaceutical company
- Courage: Be decisive, make tough choices, speak up, be ambitious and strive for better.
- Accountability: Do what you say you will, not settling; asking 'did I do my best?'
- Development: Be curious, learn every day and develop those around you so we can all be our best.
- Teamwork: Create bigger and better ideas, challenging each other and uniting behind our purpose.
Please use the cover letter to highlight how you meet the competencies required for the role. Your cover letter along with CV will be used to assess your application.
Closing date: 29 June 2018
GMC Registration (for UK applicants);
Board Certification (US) or equivalent status, ideally with recent therapeutic experience relevant to Pulmonary and/or Critical Care medicine
Clinical Development/Clinical trials experience in industry or academic settings
Scientific and clinical credibility, ideally through a track record of accomplishment in clinical medicine, academic research or industrial clinical and drug development.
Strong collaboration and partnering skills.
Demonstrable cross functional matrix leadership skills.
At GSK we are a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. Our mission is inspiring and challenging – to help people do more, feel better and live longer.
We have a long heritage in research and innovation around respiratory disease. Over the past 40 years, we have invested more in respiratory research than any other company and we continue to so, with recent first-in-class launches as well as an innovative pipeline of assets in the earlier stages of clinical development.
WHAT DO WE OFFER?
At GSK we are all inspired by the difference we make and challenge ourselves every day to improve the lives of patients and consumers. That’s why we have created an environment where everyone feels valued, able to develop, contribute to our mission and be proud of what we achieve.
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