Director, Head of DMPK and Clinical Pharmacology
Ikena Oncology (NASDAQ: IKNA) is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies and has a global strategic collaboration with Bristol Myers Squibb.
We are seeking a dynamic and motivated person to lead our DMPK and clinical pharmacology efforts across multiple programs from early discovery through clinical development. This person will be responsible for designing and analyzing outsourced in-vitro and in-vivo studies that provide insight into the ADME and PK properties for Ikena portfolio compounds. In addition, this person will provide the DMPK and clinical pharmacology development strategy to position programs for oncology clinical development in accordance with regulatory guidance. This role will have the opportunity to lead PK/PD modeling of nonclinical and clinical studies in a cross-functional collaboration with Toxicology, Translational Sciences, Pharmacology and Clinical Development teams.
- Coordinate, design, and interpret Discovery phase ADME studies and provide guidance to Discovery project teams
- Interact with medicinal chemistry team and help guide structural modifications to improve ADME characteristics of compounds for lead optimization
- Independently lead IND enabling ADME/PK studies from protocol to final reports
- Independently author DMPK sections of regulatory submissions (IND/CTA, IB, NDA, etc)
- Drive DMPK strategy for Ikena programs in Discovery and Development phases
- Successfully identify and manage CROs regarding DMPK studies and their timelines
- Translational PK/PD modeling to guide clinical study designs and dose selection
- Provide Phase 1 interim cohort PK assessment
- Design and coordinate Phase I/II PK studies (DDI, food effect, etc)
- Ph.D. in a relevant biomedical research with 10-12 years DMPK experience in pharmaceutical drug development
- Proven ability to drive drug discovery projects from early development through candidate selection and IND
- In-depth conceptual and technical expertise in drug metabolism of small molecule discovery and development programs
- Experience with in vitro/in vivo cross species ADME, mass balance, and DDI studies
- Capable of working independently in a team environment across biology, pharmacology, toxicology, translational, and clinical functions
- Experience with external vendor management such as CROs and consultants
- Must have solid grasp of ICH regulatory guidance documents relevant to ADME/PK activities supporting nonclinical development in the US and Europe
- Excellent verbal and written communication skills
- Experience in PK/PD modeling of nonclinical data using Phoenix WinNonlin
- Experience supporting clinical pharmacology/clinical PK
Personal attributes: team oriented, goal-driven, organized, highly collaborative, open-minded, data-driven, creative, persistent in the face of obstacles and uncertainty, flexible, self-aware of strengths and weaknesses, objective in the evaluation of data and strongly optimistic about overcoming challenges.