DIRECTOR, DMPK - PHARMACOKINETICS & CLINICAL PHARMACOLOGYRESPONSIBILITIES:- 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
- 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
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 BenefitsFull Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
The pay scale for this position is $216,439 to $265,200
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
