Senior Director, Clinical Pharmacology, Open to flexible working

Location
Stevenage, Hertfordshire
Salary
£Competitive
Posted
18 Sep 2020
Closes
08 Oct 2020
Ref
263535
Contract Type
Permanent

As Senior Director Clinical Pharmacology you will assume responsibility for leading a team of Clinical Pharmacology Modelling and Simulation (CPMS) colleagues to ensure that projects and the R&D pipeline receive optimal clinical pharmacology and pharmacometric support to access North Asian markets.

In particular, you will be expected to play a critical role in driving integration of end-to-end model-informed drug development in conjunction with the global CPMS group. In addition, you will be accountable for defining, coordinating and defending CPMS development strategies for North/East Asian countries at senior level meetings, and provide expert input into the clinical pharmacology evidence generation and integrated evidence plans for key therapeutic areas (oncology, immunology, respiratory and specialty, global health and ViiV).

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Define and execute a co-ordinated scientific and/or technical strategy (18-24 months planning horizon) and to co-ordinate outputs from several expertise areas to determine strategy.
  • The application of appropriate regulatory (FDA, EMA, CDE and PMDA) and ICH guidelines across major markets in the design of clinical studies and drug development strategy.
  • Review and write clinical pharmacology components of all regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology contents).
  • Approval of design, analysis, interpretation, reporting and corresponding regulatory documents across a portfolio of programs that relate to clinical pharmacology and pharmacometric aspects.
  • Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology contribution to R&D pipeline.
  • Inspire CPMS staff, identify talent, provide appropriate coaching to ensure future leadership for the CPMS organization.
  • Interact with line and middle management, staff and external contacts on a functional, strategic and tactical level.
  • Represent CPMS on various internal advisory boards, company wide initiatives and/or leadership teams
  • Promote transparency and communicate R&D achievements through publications in appropriate scientific journals

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • PhD or MD with significant experience in quantitative clinical pharmacology
  • Significant experience in different therapeutics areas in clinical pharmacology and pharmacometrics gained within the pharmaceutical industry
  • Experience working with senior stakeholders in a cross functional environment
  • Strong track record of implementation of Model-Informed Drug Discovery and Development (MID3) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs.
  • Experience with managing teams and developing staff

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Prior experience with regulatory submissions and regulatory interaction with North East Asian countries
  • Working knowledge and excellent understanding of quantitative methods using in clinical pharmacology and drug development
  • Excellent (written and oral) communication skills
  • Project experience working in a matrix environment

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 you being motivated 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.

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. 

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.

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