The role & responsibilities of the Director, DMPK at Nimbus
Reporting to VP, Preclinical Operations, the Director, DMPK will be responsible for the design, execution and interpretation of non-clinical toxicology, DMPK and translational studies. This work supports the progression of therapies from late discovery through first in human and proof of concept clinical studies. The Director, DMPK will also be responsible for the clinical pharmacokinetics and pharmacodynamics activities that support compounds as they move through early clinical development.
The Director, DMPK will:
- Represent Pharmacokinetics as a member of program, research, preclinical and clinical teams
- Propose ADME/PK 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, clinical trial design, clinical study protocols and execute and coordinate clinical trial conduct and finalize clinical study reports
- Partner with the discovery group to optimize preclinical models and inform first in patient clinical dosing strategies
- Review preclinical study reports, in conjunction with Pharmacokinetics/DMPK and prepare submission documentation
- Author nonclinical toxicology, DMPK 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
- Participate in budgeting and due diligence activities
- Execute deliverables adhering to timelines and budgets
The Qualifications We Are Seeking
- Ph.D., Pharm D. or equivalent training in pharmacokinetics, pharmaceutical sciences or relate disciplines
- Minimum 10 years of experience in bio/pharmaceutical industry, combined with drug development experience in pharmacokinetics
- Experience with regulatory submissions for small molecules with a focus on preclinical and early clinical development strategy and execution
- Experience in nonclinical toxicology
- Solid understanding of drug metabolism, bioanalysis, pharmacokinetics, preclinical pharmacology and clinical study designs
- Expertise managing CROs, GLP and other regulated activities
- Excellent communication and interpersonal skills, and proven success working in a matrix environment
A Snapshot of Nimbus
Nimbus is a biotechnology company located in the thriving biotech hub of Cambridge, Massachusetts. We transform drug development by integrating computational drug discovery techniques, a cutting-edge computational chemistry platform and other advanced technologies to design breakthrough medicines for patients.
We focus on promising targets in metabolic disease, oncology and inflammation. These include both emerging and well-validated targets that have proven intractable to others in the pharmaceutical and biotechnology industry.
Nimbus offers a fast-paced, entrepreneurial, team-focused work environment. The culture is intellectually stimulating, flexible and results-oriented. Joining our team of 30+ people offers significant opportunities to grow professionally and personally.
We also offer a top-notch benefits package (health, dental, life, vacation, and employer 401K contribution). Being part of Nimbus (a Nimbi, if you’re curious), allows you to become part of a small close-knit professional team that strives to bring out the best in each other by working hard and having fun together.