Senior or Lead Clinical Development Scientist

07 Jul 2021
06 Aug 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
At Roche, we are passionate about transforming patients' lives and we are fearless in both decision and action - we believe that good business means a better world.

That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

Collaborative innovation is at the very heart of the organisation and we invest more than most other companies 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 like-minded 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 Senior or Lead Clinical Development Scientist to join its Xofluza development team. This person will support the Clinical Science Leader (CSL) in all areas of project and study planning, evaluation, documentation and reporting.

With a proven ability to independently manage the clinical science aspects of clinical trials you will also inspire and motivate your teams and peers. 

Key responsibilities:

  • Lead and/or otherwise participate in ongoing clinical study team and Clinical Science activities in clinical trial activities, as well as other relevant team and sub-team meetings
  • Work with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Includes developing labeling and packaging language, etc
  • Contribute to 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 independent execution of, and contribution to clinical development in infectious or respiratory diseases. Candidates with experience in other therapy areas and a willingness to get up to speed quickly would also be of interest
  • Experience in contributing to an NDA/BLA/MAA/PIP/PSP or other activities involving regulatory authorities/committees in Europe and/or the U.S. or other major national Health Authority would be desirable
  • Experience in leading or contributing to the publishing of clinical trial or other results 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
  • Well-versed in 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
  • Ability to working successfully with remote teams
  • Impeccable ethics
  • Ability to travel

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.

To find out more about what it's like to work in our Immunology, Inflammation and Ophthalmology Clinical Science team in Welwyn, watch this video .

Good luck with your application.

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