Associate Director, Pharmacokinetics – Pharmacodynamics

This is a fully remote position, open to applicants in California.

📋 Description

• Lead the pharmacokinetics and pharmacodynamics (PKPD) function at Atrium Therapeutics.

• Support all facets of PKPD across various programs, from research through late-phase clinical development.

• Design, manage, and analyze nonclinical and clinical pharmacokinetic (PK), toxicokinetic (TK), and tissue distribution studies.

• Apply PKPD principles to correlate exposure with target engagement and pharmacodynamics (PD) biomarkers.

• Provide guidance on dose selection and support the rationale for first-in-human dosing.

• Evaluate the impact of immunogenicity on PK when applicable.

• Establish a bioanalytical strategy that is appropriate for the phase of development.

• Oversee the creation of Good Laboratory Practice (GLP)-compliant PK and Anti-Drug Antibody (ADA) assays in plasma and tissue matrices.

• Manage Contract Research Organization (CRO) activities, including Requests for Proposals (RFPs), Statements of Work (SOWs), budgets, timelines, and sample logistics.

• Act as the representative for PKPD on project and study teams.

• Effectively communicate PKPD strategies and interpretations of data.

• Contribute to regulatory documents, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), briefing books, protocols, and Clinical Study Reports (CSRs).

• Manage, mentor, and develop a team of both PhD and non-PhD scientists.

• Set priorities, support career growth, and foster a collaborative, high-performance culture.

⛳️ Requirements

• PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Analytical Chemistry, Biochemistry, or a related discipline.

• Over 8 years of experience in biopharma/biotech focused on nonclinical and clinical PKPD and regulated bioanalysis.

• Proven success in advancing programs from research into development.

• Experience in authoring or supporting IND submissions and engaging in regulatory interactions.

• Hands-on experience in designing and interpreting nonclinical and clinical PK studies, including Non-Compartmental Analysis (NCA).

• Strong grasp of PKPD principles.

• Familiarity with regulated bioanalysis guidelines (ICH M10, GLP/GCP).

• Experience in overseeing PK and ADA assay development and sample analysis at CROs.

• Prior experience in managing and developing scientific personnel at various levels, including both PhD and non-PhD scientists.

• Demonstrated capability to lead cross-functional initiatives and clearly communicate complex data to project teams and leadership.

• Ability to navigate ambiguity, take initiative, and solve problems hands-on.

• Experience with oligonucleotides (siRNA, ASO) and/or large molecules is preferred.

🏝️ Benefits

• Stock options and Restricted Stock Units (RSUs).

• 401(k) plan with employer matching.

• Wellness program.

• Medical coverage.

• Dental coverage.

• Vision coverage.

• Long-Term Disability (LTD) coverage.

• Unlimited time off, including breaks during summer and winter.

• Learning and development programs created specifically for Atrium employees.

• Job-specific training provided by industry professionals.

• Education reimbursement program.