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
• Cook up, 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
• 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

Qualifications

Must have solid grasp of ICH regulatory guidance documents relevant to DMPK activities

Skills

None specified

Benefits

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS004002

Ionis offers an excellent benefits package!

Follow this link for more details: Ionis Benefits Full Benefits Link

Pay

$216,439 to $265,200