Located in Redmond WA, SystImmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. We are a group of highly experienced immuno-oncology scientists utilizing several technology platforms to develop world class advanced antibody-based drug therapies.
Essential Duties and Responsibilities
- Works closely with the R&D team to provide advice on identification and selection of appropriate CROs and third-party study vendors, and ensures appropriate cross-functional input is included in the scope of work.
- Manages CROs for clinical pharmacology related studies, including study timelines, objectives and budgets. Oversees performance of CROs according to study protocol, SOPs, and ICH/GCP regulations to ensure accuracy of project progress and completion.
- Identifies, selects, and monitors performance of investigational sites for clinical pharmacology studies in patients and/or healthy volunteers.
- Helps with clinical pharmacology contributions to regulatory documents, including trial protocols and reports, investigator brochures and regulatory submission packages. Prepares clinical pharmacology support in response to regulatory agencies questions as needed.
- Optimizes doses, dosage regimens and study designs throughout clinical drug development in collaboration with statistics. Develops mathematical models to understand a disease, its progression, and drug pharmacodynamics and pharmacokinetics. Applies modeling and simulation approaches to project the human PK/PD for the starting-dose selection for first-in-human studies.
- For ongoing clinical trials, reviews clinical data in real time including patient screening results, PK/PD data, adverse events and other study endpoints whilst maintaining adherence to GCP regulations.
- Analyzes and interprets PK/PD data generated during conduct of the clinical trials, communicating results and impact of results in a timely and effective manner to clinical study teams and development sub-teams.
- Participates in the audit of the clinical report and assist the registration and declaration department to submit a new drug registration report.
- Willingness and ability to travel domestically and internationally, particularly China, as required (approximately 10-15%).
Education and Experience
- PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences or related field with 10+ years of clinical experience preferred.
- Strong understanding of FDA and GCP/ICH guidelines and the clinical development process.
- Proven ability to collaborate across departments and with outside investigators and CROs.
- Experience in designing, conducting and interpreting clinical pharmacodynamics, pharmacokinetics, and/or toxicology studies.
- Proficient in pharmacokinetic software (e.g., WinNonlin, NONMEM, Phoenix, and R etc.).
- Proven successful experience of drug candidate in INDs and/or BLAs/NDAs.
- Excellent critical thinking and analytical skills.