JOB DESCRIPTION: Associate Director, Biology
Summary:
Alaya Bioscience is a startup biotech company developing novel nanotherapeutics for infectious diseases. We are seeking an Associate Director in Biology that will support the pre-clinical development program for the investigational lead drug candidate for antibiotic resistant bacterial infections. This candidate should have an excellent knowledge of pre-clinical drug development principles focused on infectious diseases, such as pharmacodynamics/anti-microbial mechanism of actions, PK, PK/PD relationships, and a working knowledge of toxicology in relationship to pre-clinical in vitro and animal tolerability studies. This candidate will also serve as the biology project lead on advancing early drug discovery programs and will contribute as a team member to others and provide strategic visions and recommendations to Company’s senior management team.
Responsibilities will include:
- Lead early-stage project team for in vitro and in vivo pharmacology studies
- Establish external CRO-supported study plans and contracts
- Performs analysis of pharmacology data (PK/PD)
- Develops pre-clinical pharmacology data analysis plans
- Provides interpretation of pre-clinical pharmacology data and incorporates appropriate analyses into reports required for regulatory submissions
- Leads study conceptualization, protocol development, and study start-up activities
- Provides program development support with a higher level of oversight
- Collaborates with colleagues in bioanalytic, clinical development, drug metabolism and pharmacokinetics, toxicology, and regulatory affairs for clinical studies
- Demonstrates a good understanding of the requirements of the study design, conduct, analysis and report writing for regulatory submissions
Qualifications:
- Ph.D. in Life Sciences/Biological Science with 5+ years’ experience in the Biotechnology/ Pharmaceutical Industry, including project leadership experience
- Biology project leadership experience
- Able to work independently and make appropriate strategic decisions to operationalize and move the projects forward
- Demonstrates experience with IND enabling pharmaceutics research and animal experimentation
- Experience managing external CRO’s
- Excellent written and oral communication, leadership and presentation skills
- The ability to manage multiple priorities, while maintaining attention to detail is critical