Associate Director, Pharmacokinetics & Pharmacodynamics
New
A
AtriumBiopharmaceutical RNA therapeutics
Listing location: San Diego, CA; Workplace type: RemoteFull-TimeDirector
Salary185,000 - 205,000 USD per year
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Job Details
- Experience
- 8+ years of biopharma/biotech experience in nonclinical and clinical PKPD and regulated bioanalysis
Requirements
- PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Analytical Chemistry, Biochemistry, or a related field.
- 8+ years of biopharma/biotech experience in nonclinical and clinical PKPD and regulated bioanalysis.
- A record of advancing programs from research into development.
- Experience authoring or supporting IND submissions and participating in regulatory interactions.
- Hands-on experience designing and interpreting nonclinical and clinical PK studies, including NCA.
- Strong understanding of PKPD principles.
- Working knowledge of regulated bioanalysis, including ICH M10 and GLP/GCP.
- Experience overseeing PK and ADA assay development and sample analysis at CROs.
- Experience managing and developing scientific staff at multiple levels, including PhD and non-PhD scientists.
- Ability to lead cross-functional initiatives and communicate complex data clearly to project teams and leadership.
- Oligonucleotide (siRNA, ASO) and/or large-molecule experience preferred.
Responsibilities
- Lead PKPD across programs from research into late-phase clinical development.
- Design, oversee, and interpret nonclinical and clinical PK, TK, and tissue distribution studies.
- Apply PKPD principles to relate exposure to target engagement and PD biomarkers, inform dose selection, and support first-in-human dose rationale.
- Assess the impact of immunogenicity on PK where relevant.
- Set phase-appropriate bioanalytical strategy and oversee development of GLP-compliant PK and ADA assays in plasma and tissue matrices.
- Oversee CRO management, including RFPs, SOWs, budgets, timelines, and sample logistics.
- Represent PKPD on project and study teams and communicate strategy and data interpretation.
- Support regulatory documents, including IND/CTA, briefing books, protocols, and CSRs.
- Manage, mentor, and develop PKPD scientists; set priorities and support career development.
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