Position: Non-Clinical Development Manager

Location: Cambridge

Salary: Competitive

A leading Biopharmaceutical Company are looking to recruit a Non-Clinical Development Manager for their expanding Development Team.

The Role

 As the Non-Clinical Development Manager, you’ll be responsible for the management of specific non-clinical work packages necessary to support the progress of antibody product candidates through development into the clinic.

Responsibilities

To efficiently manage defined non-clinical development activities for multiple projects, which may include outsourced studies or the co-ordination of in-house activities

• Work within development project teams and take responsibility for defining and managing non-clinical activities require for specific projects
• Identify appropriate external contractor or service providers for each work package and ensure that the non-clinical project requirements are met by:
  • o Contractual engagement according to SOPs
  • o Define study protocols, work plans and costs to fit project timeline and budget
  • o Monitoring and management of contractor performance to ensure study completion according to agreed quality standards, timelines and costs
  • Review and finalisation of study documentation and reporting
  • Keep up to date with relevant regulatory guidance and industry best-practice requirements and applicable to GLP non-clinical studies
  • Assist with complication and documentation of relevant non-clinical data required to support successful IND or CTA Filings

You

 Ideally, you’ll have a BSc, MSc or PhD in a relevant biological discipline and gained extensive experience defining and implementing non-clinical work packages, including GLP studies for biologic development candidates.

You’ll have a proven track record of managing the quality performance of CROs, working knowledge of current GLP and ICH guidelines as they relate to the non-clinical evaluation of biologics and excellent management skills allied with the ability to control contractors and collaborators.

Package

 Competitive salaries and a generous benefits package are on offer including Pension, Private Health and Dental, Life Insurance, Bonus and Share Options. You’ll also be working for a growing organisation who value their employees and offer great opportunities for career development.

Company 

A leading Biopharmaceutical company who are focused on the discovery and development of fully human monoclonal antibody drugs across several therapeutic antibody programmes in Immune-oncology, auto-immunity, haematology and infectious disease.