Associate Director/Director, Clinical Pharmacologist

Located in Redmond WA, SystImmune Inc. is a clinical-stage biopharmaceutical company located in Redmond, WA. 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). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. 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.

As a Clinical Pharmacologist, the Associate Director/Director will be responsible for designing, conducting, and analyzing clinical pharmacology studies, as well as providing expert advice on pharmacokinetic and pharmacodynamic aspects of drug development and regulatory submissions. She/he will strengthen SystImmune's corporate reputation and drive employee engagement. The right individual will bring the company's story and culture to life as we further establish Systimmune as a leader in complement driven by courageous science, creativity, and compassion.

Essential Duties and Responsibilities:

• Plan and direct clinical pharmacology studies in collaboration with internal and external partners.

• Apply pharmacokinetic and pharmacodynamic modeling and simulation techniques to optimize study design, data analysis, and interpretation.

• Use biomarkers and intermediate clinical endpoints to support dose selection, efficacy, and safety assessment of drug candidates.

• Prepare and write clinical study protocols, reports, and regulatory documents in compliance with relevant guidelines and standards.

• Communicate and present clinical pharmacology findings and recommendations to internal and external stakeholders.

• Work across a variety of functions involved in drug development, such as preclinical, clinical, regulatory, biostatistics, and medical affairs.

• Work across international time zones to coordinate with global teams and vendors.

Required Skills & Qualifications:

• Ph.D., PharmD. or M.D. degree in clinical pharmacology or a related field.

• At least 5 years of experience in clinical pharmacology research in the pharmaceutical industry.

• Knowledge of biomarkers and intermediate clinical endpoints and their use in drug development.

• Proficiency in pharmacokinetic and pharmacodynamic modeling and simulation software, such as Phoenix WinNonlin, NONMEM or R.

• Conducting hands-on pharmacokinetic and pharmacokinetic-pharmacodynamic analysis for drug development projects.

• Working knowledge of US, European, and Asian regulatory requirements and guidelines.

• Experience in preparing and writing clinical study protocols, reports and regulatory documents, such as INDs, NDAs or BLAs.

• Doctorate degree and 2+ years of industry experience in assay validation in Immunology, Oncology, or related field.

• Master's degree and 4+ years of industry experience in assay validation in I/O or related field.

• Excellent communication, presentation and interpersonal skills.

• Ability to work independently and collaboratively in a multidisciplinary team.

• Ability to work under pressure and meet deadlines.

The hiring pay range for this position is $125,000 - $200,000 per year based on skills, education, and experience relevant to the role.

SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to [email protected]