Senior Pharmacokinetics Leader
1 day ago
Atavistik Bio is a pioneering biotech company dedicated to unlocking novel therapeutic approaches for unmet patient needs. Our cutting-edge platform integrates proprietary screening technology with AI-enabled drug discovery to efficiently identify and advance allosteric precision therapeutics.
We are advancing multiple high-value oncology programs, with plans to initiate clinical development in early 2025. Our team is passionate about harnessing the power of science to transform lives.
Based in Cambridge, MA, Atavistik Bio is backed by leading biotech venture capital firms, including The Column Group, Nextech, and Lux Capital.
Job Summary:
We seek a highly skilled and experienced Associate Director, DMPK, to join our development group. This individual will lead the design, execution, and interpretation of non-clinical DMPK and toxicology studies, supporting the progression of therapies from late discovery through first-in-human and proof-of-concept clinical studies.
This is an exceptional opportunity to build an efficient DMPK function and contribute to the growth of an early-stage company.
Key Responsibilities:
Represent the DMPK team 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.
Build and develop relationships with key opinion leaders and SAB members.
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 first-in-human clinical dosing strategies.
Review preclinical study reports 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.
Qualifications:
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 experience.
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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