Head of Non-clinical
Our client, a young Biotech company with an exciting pipeline in Neuroscience, now have approval to hire a Head of Non-clinical. This hire will be accountable for developing overall Non-clinical strategy in line with Clinical Development Plan, to support the development of their pipeline up to NDA submissions.
The scope of this leadership role will include the design of the company’s nonclinical safety and toxicology studies in partnership with their external consultants; and implementation of planned studies with partner Non-clinical CRO’s and oversight of such, to all company requirements and regulatory requirements.
Most importantly, in this Non-clinical / toxicology leadership role, you will be the company’s point of contact and interface with health authorities; acting as the company Non-clinical / toxicology representative and addressing questions in interactions with FDA, EMA, etc., on nonclinical toxicology and safety topics, and solving or resolving such issues.
Toxicology expertise and experience with Inhalation routes of administration through INDs, NDAs, MAAs, etc. is highly desirable.
This is a full-time permanent role, with flexibility on salary / level depending on candidate with attractive package for the right candidate. This employee will have flexibility for some remote working from their home office in Ireland, the UK, or select European countries with occasional presence for meetings in HQ when required.
Requirements include:
* PhD, MSc or equivalent BSc degree in the areas Toxicology or Pharmacology, with 10+ years related experience.
* Experience in Neuroscience is preferred. Inhalation toxicology experience is required.
* Professional toxicological registration, ERT, UKRT or DABT is preferable.
* Experience of toxicological risk assessment of impurities, extractables and leachables is beneficial but not essential.
* Demonstrates a broad knowledge in field of pharmaceutical toxicology and possesses knowledge of the relevant regulatory guidelines and preparation of submission documentation.
* Experience with IND, NDA and MAA submissions is advantageous.
* Demonstrates good medical / scientific writing skills.
* Biotech experience and the attitude and ability to be effective in a lean company environment is an advantage.
* Proven ability to interact with and seek input from external partners/experts.
* Experience in working and influencing cross-functionally.
* Flexible, able to adjust, embrace and drive change.
For further details, please contact Larry on +353 1 – 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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