|Discipline:||Medical & Pharmacovigilance|
|Salary:||£Salary: €70,000 - €95,000 Per annum Plus Benefit package / relocation allowance / ex-pat taxation|
|Contact name:||Julie Robinson|
|Contact phone:||01293 584300|
|Published:||about 1 month ago|
|Expiry date:||11 April 2021|
You will be responsible for planning, overseeing, interpreting and reporting non-clinical Safety and Toxicology Studies for early and late stage studies, with a focus on the generation of regulatory enabling GLP study packages and contributing to regulatory documentation and interactions.
The role involves designing and monitoring the non-clinical safety and toxicology studies conducted internally and externally both in a GLP and non-GLP environment and the interpretation, communication and reporting of non-clinical safety data generated.
Responsibilities of the role:
Designing, planning, monitoring and interpreting toxicity and safety pharmacology performed at CROs, ensuring presentation of data is accurate and supports the conclusions
Preparing and authoring integrative assessments of the non-clinical safety in regulatory documents (e.g. for IB, IND, IMPD, CTA, CTD, DSURs PSURs, briefing books)
Providing responses to information requests from national and international agencies related to non-clinical safety studies
Identification of threats to the pre-clinical safety assessment plan, proposing options for resolution or mitigation of these threats, ensuring the implementation of appropriate adjustments to the toxicology strategy. Actively integrating multidisciplinary research and development project teams
Maintaining expert scientific, technical and regulatory knowledge in toxicology and safety pharmacology, liaising with key consultants and scientists in the field
Interacting with competent authorities (e.g. FDA, EMA, CHMP), collaborations, partnership discussions, conferences, and scientific advisory board
PhD-level toxicology, pharmacology, veterinary medicine
Minimum 7 years’ experience in similar positions in the Biotech/Pharmaceutical industry
Proven expertise in management and leadership of multiple parallel programs in a matrix organization
Strong knowledge on the drug development process and of the regulatory environment regarding preclinical development of new drugs to support clinical development of all phases. Solid understanding of all GLP guidelines
Experience in authoring / reviewing of preclinical safety parts of regulatory documents (e.g. IB, IND, briefing books, NDA / MAA submission documents)
Understanding of the CRO’s function
Excellent understanding of pharmacological and toxicological mechanisms as the basis of developing safe medicines
Track record on supporting the development of clinical candidates
Salary: €70,000 - €95,000 Per annum Plus Benefit package / relocation allowance / ex-pat taxation
- Lead CRA
Job location: Germany Job salary: £Salary: On application
Location: Home based Germany Do you want to ...
- Head of Non-Clinical Development
Job location: Boston Job salary: £Salary: On application
The Role: Lead the nonclinical development tea...
- Director, Head of Quality Control
Job location: Raleigh Job salary: £Salary: On application
Client: Clinical stage, cell therapy biotech Lo...