Director, Nonclinical Development
HireMinds is representing a client with an exciting RNAi + AI drug discovery platform for the discovery of novel therapeutics. We're looking for someone to lead the Nonclinical Development strategy, overseeing study design, data generation, and regulatory submissions. The successful candidate will have career examples to draw from in guiding this team into clinical studies.
This is a remote role based on the East Coast (preference for the Boston area) with travel as needed.
Key Responsibilities:
- Lead nonclinical study design, execution, and regulatory submissions
- Deliver high-quality data packages to regulatory authorities
- Collaborate with cross-functional teams and manage relationships with CROs
- Add expertise to the team with insights to studies in DMPK, Pharmacokinetics, ADME, and Bioanalytical functions and study design/execution
- Provide leadership to the nonclinical team and ensure timely project completion
- Prepare and present updates to the Executive Team and work collaboratively with all stake-holders on delivering regulatory nonclinical reports
Qualifications:
- Ph.D. in pharmacokinetics, biology, pharmacology, or a related discipline, with deep expertise in drug metabolism, ADME, pharmacokinetics, and bioanalytical principles
- 10+ years of nonclinical drug development experience
- Extensive experience in nonclinical study design and execution, leading to successful regulatory submissions
- Strong knowledge of nonclinical study global regulatory requirements, including FDA, EMA, MHRA, and others, with experience supporting regulatory submissions
- Expertise in working with nonclinical CROs to deliver comprehensive plans and study protocols, while fostering strong partnerships
- Proven success and experience with IND-enabling activities and regulatory submissions
- Excellent project management, leadership, and communication skills
- Experience with modalities including: siRNA, RNAi, RNA or oligonucleotide therapeutics
