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Regulatory affairs director • huckeswagen
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Senior Director Preclinical Development Reporting to the Executive Team
AiCuris Anti-infective Cures AGWuppertal, North Rhine-Westphalia, GermanyDirector Sales (m / w / d)
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AptivWuppertal, Germany- Gesponsert
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Riedel CommunicationsWuppertalSenior Director Preclinical Development Reporting to the Executive Team
AiCuris Anti-infective Cures AGWuppertal, North Rhine-Westphalia, GermanyYour 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 latestage 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
Why us
About us
AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product PREVYMIS marketed by our partner MSD treats CMV in a defined group of transplant recipients. Our pivotal phase 3 candidate Pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people an otherwise manageable infection can mean life or death. AiCuris with its expertise and growing pipeline is committed to providing therapeutic solutions for them now and in the future.
Passionate about our mission to develop antiinfective 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 others personal and professional growth. We hire people who are collaborative adaptable communicate well and love to learn.
Required Experience :
Exec
Key Skills
Anti Money Laundering,Design Engineering,Lounge,Information Management,Deputy
Employment Type : Full-Time
Experience : years
Vacancy : 1