Senior Director Preclinical Development

vor 1 Monat

Wuppertal, Deutschland AiCuris Anti-infective Cures AG Vollzeit

**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.
- Benefits: Competitive comprehensive benefit plan

**About us**:

- Passionate about our mission to develop anti-infective therapeutics for patients in need, a team of internationally recognized experts is driving our research and development to improve the lives of patients. We believe in a culture of trust and transparency, where feedback is considered an opportunity to contribute to each other's personal and professional growth. We hire people who are collaborative, adaptable, communicate well, and love to learn.

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