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Associate Director, DMPK

4 months ago

Cambridge, United States Atavistik Bio Full time
Company Summary:

Atavistik Bio is focused on unlocking hidden functional pockets to discover transformative allosteric precision therapeutics to address serious unmet patient needs. By integrating our propriety screening technology using the body's natural regulators, with our powerful AI-enabled drug discovery platform, we are able to efficiently identify novel, biologically relevant allosteric sites for protein or RNA targets, and rapidly advance structural insights into small molecule therapeutics design. Atavistik is advancing multiple high value oncology programs and anticipates initiating clinical development in early 2025. Atavistik is based in Cambridge, MA and backed by leading biotech venture capital firms The Column Group, Nextech and Lux Capital.

Position Summary:

We are seeking a passionate and creative Associate Director, DMPK, to join our development group and work with an enthusiastic team of highly skilled scientists in a dynamic, high-growth company. Reporting to the VP, Chemical Sciences, this individual will be responsible for the design, execution, and interpretation of non-clinical DMPK, and toxicology studies. This work supports the progression of therapies from late discovery through first in human and proof of concept clinical studies. This is a great opportunity to build an efficient DMPK function while being part of an exciting early-stage company.

Key Responsibilities:
    • Representative DMPK leader as a member of program, research, preclinical and IND-enabling teams.
    • Function as a key member of Atavistik Bio's scientific leadership team, providing scientific expertise, strategic planning, and goal-oriented execution.
    • Effectively communicate scientific planning, progress, and results to executive leadership, R&D teams, and external audiences. Additionally, build and develop appropriate 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 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.
Qualifications:
    • Ph.D., Pharm. D., or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines.
    • Minimum 7 years of experience in 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 with 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 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.