Scientist​/Sr. Scientist, Clinical Pharmacology

About Syst Immune

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, as well as a robust preclinical pipeline of potential cancer therapeutics in the discover and IND‑enabling stages.

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 conduct hands‑on PK/PD modeling and simulation and provide strategic leadership across programs.

This full‑time onsite position is located in Princeton, NJ.

• Contribute to clinical development strategies of pipeline products across various therapeutic areas, design clinical studies, and develop protocols under some supervision.
• Collaborate closely with preclinical, clinical, regulatory, biostatistics, and medical affairs teams to drive drug development programs and contribute to trial designs, dosing strategies, 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.
• Conduct modeling and simulation work on PopPK, ER, PK/PD or exploratory analyses, guiding study design, dose selection, optimization, and efficacy/safety assessments.
• Own the 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.
• Manage data analysis, interpretation, and reporting with some supervision.
• Evaluate and apply new data and analyses to refine studies in the development plan.
• Stay current with the latest advancements in pharmacometric methodologies, applying innovative techniques to enhance modeling practices.
• Integrate all clinical and nonclinical data into clinical development strategy from a clinical pharmacology perspective.
• Mentor and guide junior pharmacometricians, fostering a culture of continuous learning and development.
• Prepare the clinical pharmacology data package for NDA and respond 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 minimum 2 years of relevant experience; or MS or equivalent with minimum 4 years of experience; or equivalent level of expertise and experience.
• Postdoctoral, hospital, and industry experience preferred.
• Proficient in developing NCA analysis, PopPK, PK/PD, ER analysis, MIDD principles, data visualization, results interpretation, and reporting.
• Proficiency in modeling software such as NONMEM, R, Win Nonlin, Phoenix, etc.
• Good knowledge and experience of drug development in one or more therapeutic areas.
• Critical thinking skills, with keen scientific and development judgment.
• Self‑motivated performance and ability to work on teams and in a matrix environment.
• Strong problem‑solving skills and ability to meet deadlines in a fast‑paced environment.
• Excellent communication, presentation, and interpersonal skills.
• Ability to multi‑task and prioritize assignments, establishing courses of action for self and others to ensure efficient and timely completion of work.
• Ability to work independently and collaboratively in a multidisciplinary team.

The expected base salary range for this position is $90,000 - $140,000 annually, based on a variety of factors including level, qualifications, experience, and skills. While most offers typically fall within the low to mid‑point of the range, offers may be extended toward the higher end for exceptional candidates.

Syst Immune offers a comprehensive benefits package including:

• 100% paid employee premiums for medical/dental/vision, STD, LTD.
• 401(k) plan with 50% company match up to 3%, vesting schedule of 5 years.
• 15 PTO days per year, sick leave, and 11 paid holidays.
• Additional market‑competitive benefits.

Syst Immune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.