Senior Director Preclinical Development * (Reporting to the Executive Team)
Nur für registrierte Mitglieder
Wuppertal
EUR 80.000 - 120.000
Jobbeschreibung
Your mission
Responsible for all aspects of toxicology, preclinical pharmacokinetics and safety pharmacology within AiCuris' drug development programs
Define all aspects of preclinical development and drug safety for all early and late-stage development compounds
Responsible for the setup and maintenance of an external provider network for toxicology, preclinical pharmacokinetics, safety pharmacology and preclinical development services (e.g. biomarkers, conduct of preclinical documentations, specific protocol assessments)
Supervise and monitor all preclinical drug safety evaluation studies conducted at CROs
Track reports, prepare data reviews and respond to questions raised by project teams and regulatory authorities
Propose, manage and account for the budget of preclinical development and preclinical drug safety evaluation
Define development strategies with other members of the project teams
Responsible for the generation of SOPs related to his/her area of responsibility
Responsible for the review and evaluation of external license offers
Provide preclinical development and preclinical drug safety expertise to the project team
Your profile
Doctorate degree in a discipline associated with drug development: chemistry, biology, pharmacology, toxicology or pharmacokinetics
Ideally trained as a toxicologist, but expertise in another preclinical development discipline is also a fit for the role
At least 15 years’ professional experience in preclinical science in the pharmaceutical industry with proven experience in one or more launches
Understanding of toxicology and DMPK matters with experience in discussing these with agencies
Proven record in working through consultants in biotech setting
Experience with successful interactions and filings with FDA and EMA
Experience as a cross functional manager, supervising PhDs/DVMs/MDs
Proven record in developing and implementing non-clinical development strategies
Excellent team-oriented leadership and management skills
Sophisticated communicator, able to interface and partner with executive team and to act as a champion for the programs internally
Willingness to travel to the headquarter in Wuppertal (Germany) at least once per month
Why us?
Unique corporate culture: Scientific excellence, a collaborative working environment and the passion to improve the lives of patients defines our work. With us, you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration, as well as trustful collaboration.
Development: We encourage people to grow and strongly support individual development and learning opportunities.
Flexibility: Embracing flexible working accommodations, we enable our people to integrate business into their personal life.