Roche

(Principal/ Senior) Clinical Development Scientist

Company
Roche
Location
Welwyn
Salary
Competitive
Posted
02 Oct 2019
Closes
01 Nov 2019
Ref
201909-127907
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Collaborative innovation is at the very heart of the organisation and we invest more than most other company's in R&D to drive this. We have a truly differentiated portfolio across oncology, inflammation, immunology, infectious diseases, ophthalmology and neurology which covers a uniquely broad spectrum of innovative solutions for healthcare needs of the future. Projects address all stages of prevention, diagnosis and treatment of disease as well as enhancing the quality of life.  

We are proud of our history bringing patients first-in-class and best-in-class products, and we continue to develop products that have breakthrough designations for high unmet needs. Roche has a long track record in bringing novel treatments for infectious disease to patients. With the addition to our portfolio of Xofluza, we have an opportunity for a likeminded individual with the desire to have an impact on the management of influenza to join our successful team.

Roche Product Development Clinical Science is seeking a (Principal/ Senior) Clinical Scientist to join its Xofluza development team. This person will support assist the Clinical Science Leader (CSL) in all areas of project and study planning, evaluation, documentation and reporting.

With strong ideas, and the ability to move these forward into tangible actions, you will be an innovative leader who can influence across functions and geographies.

Bringing a wealth of experience from your chosen career path so far, you will inspire and motivate your teams and peers whilst ensuring they have the opportunity to develop and strengthen their own skills and experience. Within this key role, your work will be central to advancing the clinical development of Xofluza.

Key responsibilities:

  • Lead and/or otherwise participate in ongoing clinical study team and relevant sub-team meetings, other interactions and communications,
  • Work with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Support others with clinical science information and input for regulatory submissions and other regulatory processes. Includes developing labeling and packaging language, etc.
  • Play a lead role in the development and implementation of communication strategies to support existing and concluded studies. Includes Key Opinion Leader (KOL) interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
  • Collaborate with a variety of internal and external organizations and partners, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in Product Development, research, business development, commercial operations, legal, etc.


Who you are:

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

To be successful within this role you will be or have:
  • Ideally educated to PhD level and with a track record of success in clinical development in infectious disease or respiratory. Candidates with experience in other therapy areas would also be of interest.
  • Experience submitting an NDA/BLA/MAA to regulatory authorities in Europe and/or the U.S. or other major national Health Authority would be highly desirable
  • Experience publishing results of clinical trials in a referred journal
  • Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
  • Comprehensive understanding of product and safety profiles
  • In-depth knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
  • Familiar with competitive activity in the field
  • Ability to working successfully with remote teams
  • Impeccable ethics and strong leadership skills and behaviours
  • Ability to travel up to 20%


Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

This role will be based in our UK headquarters in Welwyn Garden City, just north of London. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions.

There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day.  At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint.  A second building on-site, called The Hub, contains modern meeting room and conference facilities.

If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you. In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression. 

Good luck with your application.

Roche is an equal opportunity employer.
Research & Development, Research & Development > Clinical Operations

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