Senior Clinical Pharmacologist - Oncology Biotech

Syst Immune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). Syst Immune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. Syst Immune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development.

We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

The Scientist/Sr. Scientist, Clinical Pharmacology will support the design, execution, and analysis of clinical pharmacology studies to support drug development programs. This role will contribute to pharmacokinetics (PK), pharmacodynamics (PD), and regulatory strategy to optimize study design, data interpretation, and regulatory submissions. The successful candidate will be expected to both conduct hands-on PK/PD modeling and simulation and provide strategic leadership across programs.

This role will collaborate cross-functionally to advance Syst Immune’s pipeline of innovative oncology therapeutics and represent clinical pharmacology in regulatory interactions. It will be able to function in a blended role that includes both classical clinical pharmacology skillsets combined with quantitative analysis skills.

This is a full-time Hybrid position at our Princeton, NJ location (2-3 days in the office)

Responsible for clinical development strategy, clinical study design/protocol development, and documentation from CP perspective in the assigned project(s):

• Contributes to clinical development strategies of pipeline products across various therapeutic areas and design of clinical studies with some supervision under supervision
• Collaborate closely with preclinical, clinical, regulatory, biostatistics, and medical affairs teams to drive drug development programs and contribute to trial designs, dosing strategies, and regulatory submissions and interactions with health authorities.
• Lead the design, validation, and implementation of pharmacometric models to inform decision-making at various stages of drug development

Responsible for Pharmacometrics development, PK and PK/PD analysis, and documentation:

• Conduct modeling and simulation work on PopPK, ER, PK/PD or exploratory analyses and guides PK/PD modeling or simulations as appropriate and to guide study design, inform dose selection and optimization, and efficacy/safety assessments
• Contributes to and owns modeling and simulation plan and prepare submission packages
• Utilize modeling software such as NONMEM®, R, or other relevant tools to perform data analysis and generate modeling results
• Manages data analysis, interpretation, and reporting with some supervision
• Evaluates and applies new data and data analyses to refine studies in the development plan
• Stay current with the latest advancements in pharmacometric methodologies, applying innovative techniques to enhance modeling practices
• Integrates all available data (both clinical and nonclinical data) to clinical development strategy from CP point of view
• Mentor and guide junior pharmacometricians, fostering a culture of continuous learning and development within the team
• Responsible for clinical pharmacology data package for NDA and responding to regulatory authority queries in the assigned project(s)
• Carry out functional responsibilities in accordance with applicable SOPs and regulatory requirements

• Ph.D., Pharm.
  
  D., or equivalent with…