Science Jobs

Director, Nonclinical (Safety Pharmacology)

PHARMACOLOGY/TOXICOLOGY (SCIENCE)
  • Job ID: 19711
  • Direct Hire
  • MA
Email

Job Description
Director, Nonclinical Development

HireMinds is representing a client specializing in the siRNA, RNAi, & Oligonucleotide space that is using AI platform for the discovery of novel therapeutics. We are seeking to add your expertise Nonclinical programs for this team. As Director of Nonclinical Development, you’ll lead the strategy and execution of nonclinical programs to advance novel siRNA, RNAi, & Oligonucleotide programs. Reporting to the VP of Early-stage Development, you’ll oversee study design, data generation, and regulatory submissions. This remote role is based on the East Coast of the US with preference for close proximity to Boston, MA. You’ll specialize in Nonclinical study design and have career examples of success to draw from in guiding this team into clinical studies. 

You’ll Be Responsible For:

  • 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. 

You’ll Bring With You: 

  • 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.
  • Strong knowledge of global regulatory requirements and CRO management.
  • 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.
  • Excellent project management, leadership, and communication skills.
  • Proven success and experience with IND-enabling activities and regulatory submissions.
  • Experience with modalities including: siRNA, RNAi, RNA or oligonucleotide therapeutics.