Hobson Prior are seeking a Head of Non-Clinical Safety to join a brilliant pharmaceutical organisation on a permanent basis located either in London or in Edinburgh. Our client is focused on producing therapies that are safer for patients around the world.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this position you will be responsible for directing the determination and application of optimal non-clinical approaches for each programme in association with the company's strategy and key stakeholders, using scientific rationale to justify strategy.
• Accountable for evaluation of the non-clinical safety packages and needs for all of the company programs which involve gap analysis and risk-based considerations; nonGLP and GLP.
• You will be responsible for design, preparation and supervision of non-clinical studies, including GLP regulatory toxicology and selection and oversight of contract providers.
• Acquainted with detail of regulatory agency (MHRA, EMA and FDA) non-clinical safety requirements for advanced therapy medicinal products and GLP regulations and capable of constructing and reviewing regulatory documentation for scientific advice meetings and proficient authority submissions.
• Guide compilation and submission of the selection and development of suitable assays and biomarkers for use in non-clinical and clinical studies, this involves the supervision of laboratory work and partaking in lab work as needed.
• Delivering Non-Clinical Safety direction to multi-disciplinary teams.
• Sharing comprehensive knowledge comprehending PKPD, DMPK, Bioanalysis, Biomarkers and Quantitative Pharmacology.
• The ideal candidate will guarantee that the company pertains best practice and the principles of the 3R's to all non-clinical programmes.
• Participate, motivate and develop the non-clinical team, including proper training.
• Uphold up to date expert knowledge of regulations for ATMPs in the UK and EU with a high level of awareness of pertinent regulations in other jurisdictions e.g. US and Japan.
• Collaborate with one of the company's Chief Scientific Officer (CSO) to support commercialisation of research work.
• As the Head of Non-Clinical Safety, you will collaborate with the Director of Access Strategy to guarantee effectual and operative working in the Clinical Adoption Team.

Key Skills:

• Exceptional interpersonal, verbal and written communication skills (this involves experience in making presentations).
• Capable of taking the initiative and operate self-sufficiently; sense of urgency in accomplishing allotted errands.
• You have a flexibility towards work assignments, new learning and travel.
• High capacity to handle multiple and diverse tasks and to prioritise workload with brilliant attention to detail.
• Demonstrated ability to reliably deliver to time, cost and quality standards.
• Verified ability to engage constructively with colleagues at all levels and with a broad range of professional backgrounds across organisational boundaries to deliver objectives.
• You are a team player with strong leadership and organisational skills.

Requirements:

• Educated to PhD degree level (biological and life sciences).
• Obtained at least 10 years' or more experience in research and development of ATMPs with a focus on emerging technologies into early development / POC / FIM.
• Prior experience directing projects from pre-clinical into the clinic, taking molecules from Discovery Research to Submission.
• Familiar with a leadership role of nonGLP and GLP regulatory complaint studies.
• Previous experience of developing advanced therapy medicinal products (ATMP) and heading ATMP non-clinical safety programs is desirable, but not essential to the role.
• Former experience of operating with novel therapies where there are unknowns and novel methods and flexibility is desirable for the role.
• Documented training in GLP, GCLP and GCP.
• Previous experience of regulatory dossier Non-clinical Overviews (Module 4 of CTD/IND/IMPD), IB etc planning.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.