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Early Phase / PreClinical Study Manager

Posted:17.03.17
Location:United Kingdom
Salary:Highly Competitive
Reference No:CR.MP.11367

ProClinical is partnering exclusively with a start up pharmaceutical company based in Central London. Our client is looking for a Preclinical and Early Phase Development Manager. This can either be a contract or a permanent position. This role will be office based in Central London, and there will be some flexible working on offer.

Job Role:

  • Oversight and management of preclinical and early clinical testing of complement and biopharmaceuticals in a range of disease models to support further clinical development

Job Responsibilities:

  • Work as part of a team to rapidly identify clinical conditions. Preferred conditions are commercially viable, orphan diseases, with appropriate disease models or the option to undertake phase 1 studies within a short time frame.
  • Compile list of competitor activity / disease targets by reviewing literature on current and newly emerging preclinical and early clinical work being undertaken both by company service providers and within academic organisations.
  • Establish and maintain cordial working relationships with academic KOLs (both clinical and scientific) and relevant service providers within target disease areas.
  • Work with academic groups and CROs to develop contracts and staged proposals within target disease areas.
  • Review and tailor the proposals for scientific content and refine budgets. Identify specific milestones with timelines for each proposal including go/no-go decision points.

Steps to include:

  • Day-to-day liaison with academic groups/CROs
  • Audit raw data for accuracy, and review draft reports for completion
  • Ensure regulatory compliance of studies where applicable
  • Prepare verbal and written summaries of study reports for internal discussions
  • Oversight and reporting spend on agreed budgets
  • The candidate will work closely with / report to Medical Director and Chief Scientific Officer, but will have day-to day responsibility for the projects. 
  • They are therefore expected to have a degree of independence and exhibit this by managing bottlenecks, anticipating study problems and opportunities and raising issues with suggested resolutions to the Chief Scientific Officer.

The candidate may also be asked to undertake additional duties including

  • Contributing / reviewing to regulatory documents
  • Preparing slides and presenting to academic KOLs and service providers
  • Travelling both within and outside the UK to meet academic KOLs and service providers

Job Requirements:

  • Pharmaceutical drug development and GMP experience essential, minimum 10years in pre-clinical/phase 1 clinical development
  • Project management both academic collaborations and service providers (CROs)
  • Proven ability to write clear and comprehensive project reports
  • Proven experience of budget management
  • BSc in biological sciences BSc (Biochemistry, Molecular Biology, Pharmacy, or similar preferred)

Preferred attributes:

  • Biopharmaceutical drug development
  • Orphan disease drug development
  • Anti-inflammatory drug development
  • Knowledge of EMA and /or FDA regulatory requirements for drug development

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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