Associate Director, DMPK Lead

5 days ago

Cambridge, Massachusetts, United States Atavistik Bio Full time
Company Overview:

Atavistik Bio is a pioneering biotech company dedicated to unlocking novel therapeutic approaches. Our mission is to develop transformative allosteric precision therapeutics that address unmet patient needs. By integrating cutting-edge screening technology with AI-enabled drug discovery, we efficiently identify novel allosteric sites and advance structural insights into small molecule therapeutics design.

Position Summary:

We are seeking a highly skilled 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 a unique opportunity to build an efficient DMPK function while being part of an exciting early-stage company.

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.
• 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 on 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.
• 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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