Roche

(Senior) PD Clinical Develoment Scientist, Ophthalmology

Company
Roche
Location
Welwyn
Salary
Competitive
Posted
12 Jan 2021
Closes
11 Feb 2021
Ref
202011-129711
Hours
Full Time
Contract Type
Permanent
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.  

Roche Product Development Clinical Science is seeking an experienced Clinical Scientist to join its global ophthalmology development team. This person will support the clinical science team in all areas of project and study planning, evaluation, documentation and reporting.

This is a great opportunity to use your clinical expertise to drive the development of Roche's innovative new therapies in ophthalmology. Your contributions will be important, innovative and high profile with a global focus as you take various responsibilities for aspects of international clinical studies in a substantial phase 3 program. This position offers a wide-range of responsibilities as you assist the team in the overall management, planning, evaluation and documentation of projects and studies.

Working in a close-knit, friendly, global, professional team, you will need to be effective in an environment in which some team members are located in different geographic locations and in different time zones, so your ability to work successfully with remote teams is crucial.

Your role will include developing and writing clinical protocols and amendments, ensuring that they are medically and scientifically sound and meet all the relevant standards including good clinical practice, clinical operating guidelines, and standard operating procedures. There will also be opportunities for interaction with both internal and external stakeholders. You will monitor and review incoming data and ensure that the SOPs for evaluating, documenting and reporting adverse events are followed. Drawing on your experience within the industry you will provide innovative solutions to new and ongoing challenges.

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 our ophthalmology programs.

Key responsibilities:

  • 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.
  • 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:
  • Post graduate degree (PhD, PharmD, Pharm, MS or equivalent), with a track record of success in ophthalmology clinical development. Candidates with significant clinical science experience in other therapy areas may also be of interest.
  • Extensive clinical trial experience across Phase II - III drug development projects
  • Data listing review experience
  • 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 authoring aspects of a global clinical development plan or full clinical study protocol, and 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%


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. Find out what it's like to work in Clinical Science in Welwyn here and more about ophthalmology at Roche here .

Good luck with your application.

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

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