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• Good knowledge and understanding of clinical trial design and running late stage clinical trials.
• Knowledge & understanding of the regulatory environment.
• Possess above-study capabilities (diverse activities supporting overall clinical, regulatory, commercial objectives) that can be applied across program; links strategy with tactical approaches.
• Expertise in working with teams through a matrix environment.
• Excellent interpersonal skills, including the ability to deliver clear and effective messages both orally and in writing.
• Good organisational and time planning skills.
• A collaborative and partnering style.
• Effective leadership skills.
• Ability to deliver with high impact.
• MSc or PhD.
• Good knowledge of respiratory therapy area.
GSK are a science-led global healthcare company. We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
We are committed to widening access to our products so more people can benefit, no matter where they live in the world or what they can afford to pay.
In 2016 we produced more than two billion packs of medicine, delivered 833 million doses of vaccines and produced five billion packs of consumer healthcare products. Through our 89 manufacturing sites, we serve customers in 190 countries.
We know that we can't take on the world's healthcare challenges alone, which is why we collaborate with over 3,000 scientific, academic and charitable partners – combining expertise to accelerate progress.
GSK have been at the forefront of respiratory science for more than 40 years, providing nearly a third of all medicines taken by patients with asthma and COPD. Our medicines have benefited more than 45 million patients with asthma alone. Our respiratory medicines are available in more than 90 countries. We invest more than £4 billion annually in research and development.
● The Clinical Development Director (Senior Scientist) reports to the Respiratory Head Scientist and also would be accountable to the Project Physician Lead (PPL) in helping to define the clinical development plan and for ensuring delivery of the clinical trial program for a given asset.
● Line management for Clinical Investigation Leaders(CILs) including recruitment, mentoring of junior CILs, setting objectives, driving performance, building development plan and coaching.
● Facilitate sharing of knowledge /experience across all CILs in the department.
● As needed, take on CIL role for in-house studies or provide oversight of study-level activities for outsourced programs.
● Leadership skills –should have ability to serve as key interface with internal (across multiple line functions) and external partners to advance overall clinical development program.
● Lead & drive delivery of the clinical development plan for one or more assets or indications.
● Program management skills (“management without micromanagement”).
● Interface effectively between externalised activities (CRO) & in-house functions.
● Build trust between GSK and external partners.
● Upon agreement with the PPL the Senior Scientist may take the lead on one or more of the following activities:
● Delivery of one Clinical Development Plan (CDP) and input into medicines vision and launch excellence.
● Clinical Lead for IND, NDA/MAA submissions.
● Clinical Lead for FDA/EMA scientific advice/Ad Com activities.
● Input to product labelling.
● Lead Scientific Engagement activities including setting up advisory boards, key external experts relationship building.
● Work in partnership with Medical Communications Quality & Practice to develop publication & data dissemination strategy.
● Ensure all trials reported on Clinical Trial Register (CTR) within the required timelines.
Optimally, the Senior Scientist needs understanding of operational processes without being the hands-on expert (“spatial awareness”) and should demonstrate the ability to marshal matrix resources from other lines, including Projects, Clinical Platforms & Sciences (PCPS), as needed.
Closing date, Tuesday 24th October 2017.
You may apply for this position online by selecting the Apply now button.
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GSK is an Equal Opportunity/Affirmative Action Employer. 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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