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Job description

Site Name: Home Worker - GBR, UK - London - Brentford
Posted Date: Apr 29 2021

Senior Director Clinical Pharmacology Lifecycle Management

Brentford, UK

Or home based with travel

Are you energized by a leadership role that requires strategic thinking and extensive internal and external engagement? If so, this Senior Director Clinical Pharmacology Lifecycle Management role could be an exciting opportunity to explore.

The Senior Director Clinical Pharmacology Lifecycle Management will provide advanced clinical pharmacology, therapeutic and regulatory support for GlaxoSmithKline marketed products worldwide. The individual will also provide strategic support for evidence generation in Classic and Established Products (CEP), ensuring pro-active life-cycle management of the portfolio

This exciting role will provideyouthe opportunity to lead key activities to progressyourcareer, these responsibilities include some of the following:

  • Serving as point of contact for response to regulatory questions (RTQs) involving clinical pharmacology issues
  • Writing and reviewing clinical pharmacology study reports and regulatory documents.
  • Preparation, implementation and/or review of Global Data Sheet and label updates, with special focus on dosing recommendations, special populations (paediatrics, elderly, organ impairment, ethnic groups), drug-drug interactions (DDIs), pregnancy and lactation.
  • Maintaining an advanced knowledge of therapeutic guidelines, clinical pharmacology, drug metabolism and clinical safety (e.g. DDIs), ensuring best practice and expert support to life-cycle management activities.
  • Explore the impact of evolving technologies, including evidence synthesis by modelling and simulation using internal and external data sources to promote pro-active clinical pharmacology life-cycle management.
  • Developing and maintaining contact with internal and external scientific experts
  • Preparation, implementation, and/or review of model-informed evidence generation for CEP and specialty medicines.
  • Ensuring the integration of MIDD concepts into Clinical Pharmacology Modeling and Simulation plans and overall project and clinical development strategies
  • Thorough understanding and ability to assess requirements and apply appropriate FDA, EMA, SWISSMEDIC, China FDA, PMDA, TGA, ANVISA and ICH guidelines when new evidence is required for marketed products.
  • Approval of design, analysis, interpretation and reporting of clinical PK, PK/PD, and population PK/PD reports.
  • Writing and reviewing the clinical pharmacology and clinical overview modules of regulatory filings and responses such that GSK and ViiV products are efficiently approved with optimum labelling

Why you?

We are looking for candidates with the following qualifications:

  • PhD or MD with prior experience in clinical pharmacology and and late stage clinical (Phase IIb/III and IV) drug development,
  • Working knowledge of modelling & simulation methods and concepts
  • Good understanding of regulatory processes and procedures
  • Proven leadership and performance in a matrix team environment
  • Proficiency in English and excellent writing and communication skills.

Why GSK?

At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.

When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about youbeingmotivated to do your best work, in a place where you can be you, feel good and keep growing.

Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During the course ofyourapplicationyou will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your abilityto perform the jobrequirementsplease contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

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 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.

Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email [email protected]

As 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/ Agencies

GSK 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 For the Record site.

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