Associate Director, DMPK Lead
1 week ago
We are seeking a highly skilled Associate Director, DMPK to join our development group at Atavistik Bio. As a key member of our scientific leadership team, you will be responsible for designing, executing, and interpreting non-clinical DMPK and toxicology studies to support the progression of therapies from late discovery through first in human and proof of concept clinical studies.
Key Responsibilities- Represent the DMPK function as a member of program, research, preclinical, and IND-enabling teams.
- Provide scientific expertise, strategic planning, and goal-oriented execution as a key member of Atavistik Bio's scientific leadership team.
- Effectively communicate scientific planning, progress, and results to executive leadership, R&D teams, and external audiences.
- Propose ADME/PK, biodistribution, and PK-PD approaches at team discussions of high impact on project progression.
- Identify and manage consultants and vendors to support ADME, PK, and PK/PD studies.
- Contribute to candidate selection, development strategy, and coordinate IND-enabling study reports.
- Partner with the discovery group to optimize preclinical models and inform on first in human clinical dosing strategies.
- Review preclinical study reports, in conjunction with Pharmacokinetics/DMPK, and prepare regulatory submission documentation.
- Author DMPK, nonclinical toxicology, and biomarker sections of regulatory documents.
- Collaborate cross-functionally with all relevant areas to support strategic objectives.
- Communicate status updates and program issues to appropriate team members.
- Ph.D., Pharm. D., or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines.
- Minimum 7 years of experience in the bio/pharmaceutical industry, combined with drug development.
- Excellent communication and collaborative skills to work on project teams with chemists, biologists, and platform scientists.
- Highly organized, self-motivated, and a desire to succeed in a fast-paced organization.
- Experience with regulatory submissions for small molecules, with a focus on preclinical and early clinical development strategy and execution.
- Experience in nonclinical toxicology is a plus.
- Solid understanding of drug metabolism, bioanalysis, pharmacokinetics, preclinical pharmacology, PK/PD modeling, and clinical study designs.
- Expertise in managing CROs, GLP, and other regulated activities.
- Ability to operate objectively and independently as a leader and as a member of a team.
- Must be able to work on multiple projects simultaneously.
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