Daily Responsibilities
- Serve as a subject matter expert on Preclinical PK/PD within Discovery-stage project teams and guide the design of preclinical PK/pharmacology studies.
- Collaborate with internal groups (Therapeutic Proteins, Therapeutic Function Areas, Assay Development, Precision Medicine, Preclinical Operations, and PPK/PD management) to develop and execute PK strategies for projects.
- Communicate project team queries, expectations, and timelines to management.
- Conduct and report PK/PD analyses based on data from preclinical studies.
- Partner with Toxicology, Pathology, Clinical Pharmacology, and Quantitative Pharmacology teams to deliver data and regulatory documents supporting project progression.
- Maintain current knowledge of scientific literature, regulatory guidance, and best practices related to PK/PD.
This Role Might Be For You If You
- Thrive in a fast-paced, collaborative environment.
- Passionate about science and motivated to help bring new drugs to patients.
- Desire exposure to multiple therapeutic areas and emerging modalities.
- Excellent written and verbal communication, presentation, influencing, and leadership skills.
To Be Considered, You Must Have
- PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry with 8β10+ years of relevant biotech/pharma experience.
- Deep theoretical and applied understanding of PK/PD to interpret pharmacology and biology of therapeutic proteins; experience with siRNA, CRISPR-based therapeutics, and/or cell therapies is highly beneficial.
- Proven ability to plan, coordinate, lead PK and/or PK/PD studies, and analyze data.
- Familiarity with PK/PD tools (e.g., WinNonLin), data visualization and AI software; experience writing scientific reports and regulatory summaries.