Assistant Director, DMPK

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.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

ASSISTANT DIRECTOR, DMPK

POSITION 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 Benefits

Full 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.

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