Director Clinical Pharmacology Lifecycle Management
GlaxoSmithKline
A fantastic opportunity is available within GSK’s Clinical Pharmacology Lifecycle Management team for an experienced individual who will provide clinical pharmacology, therapeutic, and regulatory support for GSK portfolio.You will ensure optimal application of clinical pharmacokinetic (PK), pharmacodynamic (PD), and modelling & simulation (M&S) principles towards efficient evidence generation for the registration and life-cycle management of medicinal products.Main accountabilities include:
Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:PhD and/or MD degree in clinical pharmacology or similar disciplineRelevant experience in the application of clinical pharmacology, modelling and simulation methodologies to drug development and lifecycle management, ideally gained within a pharmaceutical companyExperience and understanding of regulatory guidelines, ideally demonstrated experience interacting with regulatory authoritiesPreferred Qualifications:If you have the following characteristics, it would be a plus:Knowledge of pharmacology, physiology, clinical pharmacology, biopharmaceutics, regulatory affairs, therapeutics and commercialization such that he/she can assist in managing these interfaces and promote a strong partnership with Medical Affairs, Clinical Safety and other relevant business partners.Experience in the design, analysis, interpretation and reporting of clinical pharmacology studies, including bioequivalence, concentration-QT, organ impairment, and other special populations (e.g. Japanese, older adults)Working knowledge in standard and innovative clinical study protocol design across different phases of development and life-cycle management, including evaluation of real-world evidenceExperience in quantitative clinical pharmacology, including population PK modelling, drug-disease modelling, clinical trial simulations, and dosing algorithmsUnderstanding of statistical methodologies: ANOVA, hypothesis testing, Bayesian inference, nonlinear mixed-effects modellingExcellent written (scientific and non-technical) communication skills in EnglishBeing a team player and functioning effectively in a matrix team settingWhen applying for this role, please download your CV in English + a cover letter to describe how you meet the competencies for this role.*LI-GSKWhy GSK?Uniting science, technology and talent to get ahead of disease together.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.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 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. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0808 234 4391.Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the and scroll to the Careers Section where you will find answers to multiple questions we receiveAs 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting site.
United Kingdom
Sun, 01 Sep 2024 07:55:48 GMT
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