Head of Non–Clinical & Technical Development (Pharmaceutical R&D)
- Recruiter
- Mundipharma
- Location
-
Cambridge
East of EnglandUnited Kingdom
- Salary
- Competitive
- Posted
- 30 Nov 2020
- Closes
- 24 Dec 2020
- Job Title
- Director
- Category
- Scientific and Pharmaceutical
- Contract Type
- Permanent
- Hours
- Full Time
*About Us*
Since the global network was founded in 1952 by a family of physicians, the Mundipharma network has always challenged conventional wisdom, and we expect the same from our employees. If you crave the freedom to think and work in new ways, then this is the place for you. Our flat organization allows you to make decisions and deliver results fast, which makes this an exhilarating and exciting place to work regardless of your role.
*Job Description*
To lead the strategic input for all non–clinical development aspects (pharmacology and toxicology) of the Mundipharma drug development and lifecycle management portfolio.
To oversee and manage the implementation of these strategies utilising predominantly external resources including CROs and consultants.
This role will have line management responsibility for the non–clinical team of 1–2 senior toxicologists, as well as a small team of technical development scientists; whilst a toxicology background is an essential requirement for this role, experience in technical development for pharmaceuticals or consumer health products would be a bonus.
As a member of the R&D Leadership Team, play a visible role in the development of the non–clinical / technical development group, as well as the strategy for the broader Mundipharma R&D group.
*Duties & Responsibilities*
• Development and leadership of the non–clinical strategy, and delivery of non–clinical data requirements (scientific and regulatory) for projects across the Mundipharma portfolio.
• Oversight of technical development activities for key projects in the Mundipharma pharmaceutical and consumer health portfolio.
• Liaise with key functions (e.g. Regulatory Affairs, Clinical, Drug Safety) as well as internal governance committees, to ensure appropriate provision of non–clinical data, evaluations and advice for the Mundipharma development and marketed product portfolio.
• Liaise with key functions (e.g. Tech Ops, Quality, Regulatory CMC), as well as internal governance committees, to ensure appropriate delivery of technical development activities.
• Develop and maintain a network of external partners/ contractors and consultants with appropriate expertise and experience in established and new project/therapeutic areas.
• Give clear and decisive leadership, both internally and externally, of non–clinical development strategy, and technical development strategy, and associated work undertaken.
• Agree and monitor the setting and completion of non–clinical and technical development objectives and timelines for R&D projects, in conjunction with asset team members / leaders.
• Work effectively with other functions within R&D to efficiently achieve high quality results and generate a high functioning team ethos.
• Line management responsibility for team of 1–2 toxicologists and 2–3 technical development scientists, providing coaching, and managing team workload to ensure adequate resources are available to meet functional objectives.
• Ensure appropriate external partners/ contractors and consultants are identified, audited and selected to conduct practical nonclinical studies. Ensure appropriate external partners are identified, audited and selected to deliver technical development activities. In conjunction with Legal and Outsourcing, ensure appropriate commercial contracts and technical agreements are established.
• Ensure that Health, Safety & Environmental, COSHH, GLP, GMP and other GXP requirements are complied with at all times. Ensure external partners / contractors / collaborators are aware of their own responsibilities and obligations in these areas.
• Ensure liaison with Clinical, Drug Safety, Quality and Regulatory functions to facilitate the provision of appropriate data and reports to support generation of high–level regulatory documentation such as INDs, IBs, CTAs and MAAs. Liaise with colleagues in other sites within Research and Development to ensure common standards and working practices are adopted wherever possible.
• Develop, review and monitor standards and procedures for work conducted through partners/ contractors / collaborators.
• Ensure communication of progress on projects, costs against budget and any other aspects of the work.
• Ensure training and development is maintained to fulfil current responsibilities, to prepare for new responsibilities and to fully realise potential of self and line reports.
• Carry out administrative activities required to comply with Company and R&D practices and to ensure smooth day to day running of the department.
*Who we're looking for*
• Expert–level knowledge of non–clinical drug development (especially safety pharmacology and toxicology).
• Experienced in non–clinical in vivo study design (especially safety pharmacology and toxicology), monitoring, reporting and outsourcing.
• Deep understanding of and experience in non–clinical regulatory requirements, processes and documentation.
• Previous experience in technical development for pharmaceuticals or consumer health products would be a bonus.
Can consider part time applicants
*Do you think you could help us see what others don't? Be inquisitive and help us move medicine forward!*
Since the global network was founded in 1952 by a family of physicians, the Mundipharma network has always challenged conventional wisdom, and we expect the same from our employees. If you crave the freedom to think and work in new ways, then this is the place for you. Our flat organization allows you to make decisions and deliver results fast, which makes this an exhilarating and exciting place to work regardless of your role.
*Job Description*
To lead the strategic input for all non–clinical development aspects (pharmacology and toxicology) of the Mundipharma drug development and lifecycle management portfolio.
To oversee and manage the implementation of these strategies utilising predominantly external resources including CROs and consultants.
This role will have line management responsibility for the non–clinical team of 1–2 senior toxicologists, as well as a small team of technical development scientists; whilst a toxicology background is an essential requirement for this role, experience in technical development for pharmaceuticals or consumer health products would be a bonus.
As a member of the R&D Leadership Team, play a visible role in the development of the non–clinical / technical development group, as well as the strategy for the broader Mundipharma R&D group.
*Duties & Responsibilities*
• Development and leadership of the non–clinical strategy, and delivery of non–clinical data requirements (scientific and regulatory) for projects across the Mundipharma portfolio.
• Oversight of technical development activities for key projects in the Mundipharma pharmaceutical and consumer health portfolio.
• Liaise with key functions (e.g. Regulatory Affairs, Clinical, Drug Safety) as well as internal governance committees, to ensure appropriate provision of non–clinical data, evaluations and advice for the Mundipharma development and marketed product portfolio.
• Liaise with key functions (e.g. Tech Ops, Quality, Regulatory CMC), as well as internal governance committees, to ensure appropriate delivery of technical development activities.
• Develop and maintain a network of external partners/ contractors and consultants with appropriate expertise and experience in established and new project/therapeutic areas.
• Give clear and decisive leadership, both internally and externally, of non–clinical development strategy, and technical development strategy, and associated work undertaken.
• Agree and monitor the setting and completion of non–clinical and technical development objectives and timelines for R&D projects, in conjunction with asset team members / leaders.
• Work effectively with other functions within R&D to efficiently achieve high quality results and generate a high functioning team ethos.
• Line management responsibility for team of 1–2 toxicologists and 2–3 technical development scientists, providing coaching, and managing team workload to ensure adequate resources are available to meet functional objectives.
• Ensure appropriate external partners/ contractors and consultants are identified, audited and selected to conduct practical nonclinical studies. Ensure appropriate external partners are identified, audited and selected to deliver technical development activities. In conjunction with Legal and Outsourcing, ensure appropriate commercial contracts and technical agreements are established.
• Ensure that Health, Safety & Environmental, COSHH, GLP, GMP and other GXP requirements are complied with at all times. Ensure external partners / contractors / collaborators are aware of their own responsibilities and obligations in these areas.
• Ensure liaison with Clinical, Drug Safety, Quality and Regulatory functions to facilitate the provision of appropriate data and reports to support generation of high–level regulatory documentation such as INDs, IBs, CTAs and MAAs. Liaise with colleagues in other sites within Research and Development to ensure common standards and working practices are adopted wherever possible.
• Develop, review and monitor standards and procedures for work conducted through partners/ contractors / collaborators.
• Ensure communication of progress on projects, costs against budget and any other aspects of the work.
• Ensure training and development is maintained to fulfil current responsibilities, to prepare for new responsibilities and to fully realise potential of self and line reports.
• Carry out administrative activities required to comply with Company and R&D practices and to ensure smooth day to day running of the department.
*Who we're looking for*
• Expert–level knowledge of non–clinical drug development (especially safety pharmacology and toxicology).
• Experienced in non–clinical in vivo study design (especially safety pharmacology and toxicology), monitoring, reporting and outsourcing.
• Deep understanding of and experience in non–clinical regulatory requirements, processes and documentation.
• Previous experience in technical development for pharmaceuticals or consumer health products would be a bonus.
Can consider part time applicants
*Do you think you could help us see what others don't? Be inquisitive and help us move medicine forward!*
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