Director, DMPK- Pharmacokinetics & Clinical Pharmacology (Carlsbad)

Director, DMPK- Pharmacokinetics & Clinical Pharmacology

Job Category : Development - Ionis

Requisition Number : IONIS004002

• Posted : March 12, 2026
• Full-Time

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Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA‑targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

DIRECTOR, DMPK - PHARMACOKINETICS & CLINICAL PHARMACOLOGY

RESPONSIBILITIES:

• Drive DMPK strategy for programs in Discovery and Development phases and represent the DMPK function to project management and leadership teams
• Coordinate, design, and interpret Discovery and Development phase CRO‑based ADME evaluations of novel RNA therapeutics including radio‑labelled, CYP and transporter related DDI assessment, protein binding, plasma blood cell partition, and PK studies by working with PK scientists/project leads and provide guidance to Discovery and Development project teams
• Lead an internal lab for metabolism evaluation to provide guidance and expertise on metabolite ID with innovative methodologies and bioanalytical methodologies for new chemical entities including ASO, siRNA, ligand‑conjugated targeting strategies, and other molecular modalities
• Interact with medicinal analytical chemistry team to support structural modifications to optimize ADME characteristics of compounds in lead optimization
• Provide expert advice and guidance on IND enabling ADME and PK studies from protocol to finalized reports
• Author DMPK sections of regulatory submissions (IND/CTA, IB, NDA, etc)
• Successfully identify and manage CROs regarding DMPK study execution and reporting to meet program timelines, develop effective relationships with external consultants
• Support PK modeling to inform clinical dosing strategies by working with PK/clin pharm scientists
• This position will have direct report(s)

REQUIREMENTS:

• Ph.D. in relevant biomedical research with 12+ years DMPK experience in pharmaceutical drug discovery and development
• Strong track record of publications and authoring submission documents, addressing regulatory questions
• Proven ability to drive drug discovery projects from early development through candidate selection and IND
• In-depth conceptual and technical expertise in drug metabolism and bioanalysis in NME discovery and development programs, especially ASO, siRNA and RNA therapeutics experiences are highly desirable
• Experience with in vitro/in vivo cross species ADME, mass balance, and DDI studies
• Expertiseon metabolite ID and method development, extensive experience in LC‑MS/MS, LC-ToF MS, and LC-HRMS.
• Strong understanding and experience in interpreting DMPK data and the relationships between metabolism and pharmacokinetics.
• Excellent verbal and written communication skills, as well as the ability to contribute effectively in fast‑moving inter‑disciplinary project teams
• Experience with external vendor management such as CROs and consultants
• Must have solid grasp of ICH regulatory guidance documents relevant to DMPK activities

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

The pay scale for this position is $216,439 to $265,200

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.