Director, DMPK

Atavistik Bio - Cambridge, MN

- Senior

Cambridge, MN

Professional, Scientific, and Technical Services

About the position

We are seeking a strategic and creative Director, DMPK, to join our R&D group and work with an enthusiastic team of highly skilled scientists in a fast-paced environment. Reporting to the Senior VP, Drug Discovery, 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.

Responsibilities

• Representative DMPK leader as a member of 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.
• 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.

Requirements

• PhD., Pharm. D. or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines.
• 5+ 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.