Posted

30+ days ago

Description

Swiss Precision Diagnostics (SPD) are currently recruiting for a Senior Clinical Research Scientist who will work with multiple functions facilitating clinical study design, study reporting and publication of study results to support product validation, regulatory submission, claim substantiation and exploratory research. The role holder will contribute to promoting and sustaining our leading brand position through reporting and publication of results.

This is a full-time, permanent role that will be based at our site in Bedford, UK and will report into the Clinical Programme Manager.

Main Responsibilities

  • Leads the multi-functional development of clinical documentation for product validation, claims substantiation and exploratory research including: clinical development plans, protocols, reports and summary reports.
  • Ensures work instructions, templates and guidance documents required by clinical research scientists are appropriate and up-to-date.
  • Facilitates submission of study documentation for ethics approval.
  • Inputs clinical considerations required for regulatory submissions, and liaise with regulators to ensure clinical plans meet requirements. Provide support for clinical and scientific queries from regulators during technical review.
  • Provides support for the writing of clinical documentation for regulatory submissions and scientific publication.
  • Presents study findings both internally and externally e.g. to key opinion leaders, conferences and through learning lunches.
  • Leads exploratory research studies to assess feasibility of concepts for new products, such as early biomarker identification.

Person Specification

  • Must hold a Scientific Degree.
  • Significant clinical research experience in study design and reporting for IVD/Medical Device/ Pharmaceutical or Biotech setting.
  • Proven experience of medical and/or clinical writing including protocols, reporting and publication.
  • Evidence of conducting exploratory research projects in a commercial setting.
  • Understanding of immunoassays, especially lateral flow devices.
  • Background understanding of the biology of pregnancy and reproductive health.
  • Excellent communication skills with experience of presenting and interfacing with reproductive healthcare professionals.
  • Willing to travel within Europe and the US where necessary, plus there will be some UK travel too.

What we can offer you

  • Generous 25 days paid annual leave plus bank holidays
  • Company pension scheme including employer’s contribution
  • Excellent Private Medical Insurance package with additional medical cash plan scheme
  • Enhanced maternity and paternity pay
  • Company supported employee Health & Wellbeing programme
  • Life assurance
  • FREE parking including free electrical car charging points & disabled parking facilities
  • Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road & rail)

If you require any reasonable adjustments to support you, at any stage during the application process, just let us know how we can help.

We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status or disability status.

About SPD

Swiss Precision Diagnostics (SPD) was formed in 2007 as a joint venture between Procter & Gamble (P&G) and Alere (now Abbott) to create, using its parent companies’ complementary strengths, one of the world's foremost organisations in consumer diagnostics.

We are a leading supplier of home pregnancy and fertility/ovulation tests. Our brands include Clearblue. These are products designed to give women a better understanding of their own reproductive health and invaluable guidance in their family planning. Our research interests are in the broad application of innovative technologies for use by the consumer at home. We have a strong focus on women's reproductive health and our goals are in the continuing supply of useful diagnostic products which are accurate, simple and affordable. In the achievement of these goals, we believe that SPD consumer diagnostic products will make increasing contributions to personal healthcare and well-being.

SPD’s Head Office is based in Geneva, Switzerland, and our Innovation Centre is based in Bedford, UK. SPD employs around 180 people.