Title: Principal Toxicologist / Director
Location: Cambridge, UK
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. At MedImmune our employees make up a diverse and modern workforce. Our culture is defined by a strong sense of collaboration. We believe in rewarding talent and performance, and pride ourselves on being a great place to work.
Within the Biologics Safety Assessment (BSA) department, Toxicology project leaders (TPLs) at the Principal Toxicologist or Director level are key functional representatives that have broad drug development experience and play a key role formulating functional strategy, represent BSA in governance committees (e.g. Research Review Committee (RRC), Innovative Medicines Development unit (iMED)), and are key functional representatives to high profile Research Project and Product Development Teams. Directors/Director, Fellows are expected to have in depth understanding of biologics drug development and may be aligned to a specific therapeutic area. In addition, Directors/Director, Fellows are expected to lead Translational Science Subteams. Directors but not Director, Fellows are expected to have management responsibilities.
Some of the responsibilities include:
- Development of appropriate strategies to assess nonclinical safety of MedImmune assets; this includes high level input into designing studies and actively contributing to inclusion of pharmacodynamic readouts in these studies.
- Organising, planning and data monitoring of in vivo toxicology studies in collaboration with Associate Toxicologists and Toxicologists.
- Oversee the delivery of reviewed and approved final toxicology study reports, suitable for regulatory submission, in collaboration with Associate Toxicologists and Toxicologists.
- Contribute to regulatory documents (CTAs, IMPDs, INDs, BLAs, etc); be involved in interactions with regulatory authorities as needed.
- Communicate toxicology data internally and to Research Project and Product Development Teams, ensuring delivery in line with the business objectives of validity, integrity, quality, timing & cost.
- Attend and/or present at relevant governance committees, including but not limited to Research Review Committees (RRC), the MedImmune Safety Review Board (MSRB), and the Early and Late Stage Product Committees (ESPC, LSPC).
- Identify threats to the nonclinical safety assessment plan, propose options for resolution or mitigation of these threats, and ensure implementation of appropriate adjustments to the nonclinical safety strategy.
- Act as a key functional expert in the field of nonclinical safety testing of biologics and maintain immunological and toxicological expertise; this includes, but is not restricted to, keeping up todate with the scientific literature, attend and contribute to relevant international meetings, and publish in peer reviewed journals.
- PhD degree in a relevant subject area
- Extensive experience with managing CRO-based toxicology studies, including experience with studies in common toxicology species (rats and especially nonhuman primates)
- Proven pharmaceutical industry experience in the field of nonclinical safety testing of biologics
- Understanding of the regulatory requirements for the toxicology testing of biologics
- Understanding of toxicological mechanisms as the basis of developing safe medicines
- Experience with acting as nonclinical safety representative in early stage (lead optimisation-IND-Phase I) as well as later stage project teams (Phase II and beyond) Experience with preparing and submitting regulatory documentation (CTA/IND, briefing documents) and regulatory interactions
- Other relevant professional qualifications or recognition, e.g. DABT/ERT
- Specialist expertise in a field relevant to nonclinical safety testing of biologics, e.g. immunology/immunotoxicology
- Recognised as an industry leader in the field of biologics safety testing as evidenced by publication record and involvement in professional organisation
Closing date: 31st August 2017
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.