Director, DMPK- Pharmacokinetics & Clinical Pharmacology

Director, DMPK - Pharmacokinetics & Clinical Pharmacology

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!

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

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

Expertise on 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