Associate Director/Director, Clinical Pharmacologist
Location
Redmond, WA | United States
Job description
Associate Director/Director, Clinical Pharmacologist
Redmond, WA 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]
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Salary