ASSISTANT DIRECTOR, DMPKPOSITION SUMMARY:The Assistant Director, DMPK, will contribute scientific expertise for the development and execution of fit-for-purpose DMPK strategies supporting Ionis therapeutic programs from discovery through clinical development, as a DMPK project representative under the supervision of Head of DMPK.
This role will combine hands-on scientific expertise with technical oversight of internal laboratory activities and outsourced studies. They will bring exceptional expertise in metabolite identification and profiling, LC-MS/MS and high-resolution mass spectrometry, quantitative bioanalysis, and the interpretation of complex modalities MS data.
The successful candidate will serve as a trusted DMPK partner and expert to multidisciplinary project teams, translate complex data into clear development recommendations, and help ensure that DMPK data are scientifically rigorous, timely, and decision-ready for candidate selection, IND/FIH, and later-stage development. This is an individual-contributor role with no direct reports; influence will be exercised through scientific leadership, collaboration, and technical mentorship.
WORK LOCATION: CARLSBAD, CA
KEY RESPONSIBILITIES:Scientific and program execution
- Support the development and execution of DMPK strategies for discovery, IND-enabling, and clinical-stage programs, under the guidance of the Head of DMPK
- Review data and study reports addressing plasma protein binding, CYP and transporter interactions, hepatocyte stability, mass balance and excretion, QWBA, blood partitioning, and metabolite identification.
- Recommend fit for purpose approaches for characterizing the active component, ligand, linker, and relevant metabolites.
- Provide technical input on DMPK risks, assay limitations, study priorities and follow-on work.
Biotransformation and Bioanalytical support
- Execute hands-on development, optimization, qualification, and application of methods using LC-MS/MS, UHPLC-HRMS, ligand-binding, and hybrid assay formats.
- Establish fit-for-purpose workflows for metabolite identification, metabolite profiling, semi-quantitation, and ultra-sensitive quantitation in relevant biological matrices.
- Help build laboratory capabilities for analyzing peptide-conjugated ASOs and siRNAs, VHH-Fc or albumin-binding half-life extenders, TfR-targeted conjugates, and other systemic or CNS-directed constructs.
- Contribute to continuous improvement of in-house DMPK capabilities, workflows, training, and scientific standards.
CRO and study oversight
- Provide technical leadership for CRO activities, including provider selection, scope of work, timelines, method development and transfer, qualification, critical-reagent planning, data review, and report completion.
- Review CRO protocols, methods, data, reports, and deviations for scientific quality, completeness, consistency, and alignment with program objectives.
- Identify risks early, resolve technical issues, and ensure that outsourced studies generate reliable and interpretable data.
Regulatory and technical communication
- Review, and contribute to method-development and validation plans, qualification and validation reports, sample-analysis plans, bioanalytical and DMPK study reports, investigator-brochure summaries, and relevant IND, IB, CTD, and NDA sections.
- Support responses to technical questions from regulatory agencies and maintain documentation suitable for inspection and regulatory review.
- Present data, conclusions, and recommendations to internal project teams, senior leadership, external collaborators, partners, and potential partners.
REQUIREMENTS:- Ph.D. in pharmaceutical sciences, analytical chemistry, biochemistry, pharmacology, or a related discipline with at least 5 years of relevant industry experience
- Extensive hands-on experience developing, qualifying, and applying bioanalytical and DMPK methods, with demonstrated expertise in high resolution mass spectrometry operation and troubleshooting.
- Hand-on experience with diverse bioanalytical sample preparation methodologies such as protein precipitation, liquid-liquid extraction, solid phase extraction, immunocapture, hybridization, etc.
- Hands-on experience with LC-MS/MS, HRMS, metabolite identification and profiling, quantitative bioanalysis, sample preparation, and interpretation of data from complex biological matrices.
- Strong understanding of ADME principles across multiple delivery routes, dosing regimens, modalities, and conjugates.
- Working knowledge of GLP requirements and regulatory guidance relevant to bioanalysis, DMPK, metabolite safety, and clinical development.
- Excellent written and oral communication skills, including the ability to present complex technical findings to multidisciplinary audiences and provide constructive technical direction to CROs and laboratory personnel.
- Strong organizational skills, attention to detail, commitment to data integrity, and ability to work collaboratively in a fast-paced, cross-functional environment.
PREFERRRED QUALIFICATIONS- Experience with bioanalysis/biotransformation of oligonucleotide therapeutics, including ASOs, siRNAs, ligand-conjugated oligonucleotides, peptide conjugates, or related novel modalities.
- Experience with Thermo Exploris, Q-Exactive or comparable high-resolution mass spectrometry platforms and metabolite identification software such as BioPharmaFinder, Promass HR or MassMetasite.
- Experience with CYP inhibition/induction, drug transporters and other DDI assays.
- Experience supporting IND, IB, CTD, NDA, or other regulatory submissions.
- A record of scientific leadership demonstrated through presentations, publications, cross-functional program contributions, or external collaborations.
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS004045
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis BenefitsFull Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
The pay scale for this position is $153,848 to $200,000
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
