Job Detail

Principal Toxicologist

Description
Function Principal toxicologist
Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne
hr@acimmune.com
Percentage 100 % - available immediately
Reporting Line Group Leader, in vivo pharmacology and non-clinical safety
Company Profile •AC Immune is a clinical stage Swiss biotech company focused on the
development of innovative therapeutics and diagnostics for Alzheimer’s
and other neurodegenerative diseases

• 140+ Employees, 20+ nationalities, IPO in 2016, listed on NASDAQ


• AC Immune SA is a progressive, equal opportunity employer

Job description Principal toxicologist with strong expertise in non-clinical safety to support
candidate selection and preclinical development of small molecules and
biologics. Main focus will be the direct supervision of toxicology and safety
pharmacology studies as well as the supervision of a in vitro safety scientist.
Key Responsibilities •Set the overall strategy for toxicology programs for the various projects at
ACI in consultation with Senior Management

• Design, implement and manage toxicology and non-clinical safety
  pharmacology studies


• Supervise the analysis and data interpretation of in vitro safety studies


• Recommend and manage selected CRO relationships including the
  coordination of (from initial contract to archiving) outsourced studies to
  ensure accurately reporting of results, compliance with study protocol and
  regulatory requirements.


• Provide interpretation of the data and toxicology guidance to the internal
  clinical, regulatory and research groups.


• Take responsibility for the writing of the non-clinical safety and toxicology
  sections of regulatory documents and interactions with health authorities.


• Review of scientific literature relevant to preclinical product development.


• Ensure compliances with GLP regulations in designing protocols, analyzing
  and interpreting the data and preparing relevant documentation.


• Support the business development team on technical due diligence
  associated with out-licensing, and co-development agreements regarding
  non-clinical safety aspects.


• Complete activities in a timely manner that allow a project to achieve
  deliverables and milestones


• Provide toxicology and non-clinical safety expertise as a project team
  member

Qualifications & Skills The candidate should have the following qualifications:

• Ph.D. in Toxicology or Pharmacology, Biology or Immunology or
  alternatively 3-5 years of study director experience in a CRO


• At least 5-7 years of non-clinical safety experience in the biotechnology or
  pharmaceutical industry and track record of interacting with regulatory
  agencies


• Supervisory experience in the biotechnology or pharmaceutical industry or
  a respective CRO


• Current with GLP regulations and experience in writing SOPs and study
  reports


• Leadership and project management skills


• Have excellent interpersonal, analytical and communication skills as well
  as fluent in speaking and writing in English


• Able to build effective working relationships within the company and with
  external partners as a team player