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Johns Hopkins University
Seattle, WA, United States
Johns Hopkins University Director, Clinical FP&A Baltimore , Maryland Apply Now SOM Central Finance is seeking a Director, Clinical FP&A leader to join their team and lead crucial financial strategies and operations. In this role, the Director, Clinical FP&A will coordinate assignments, create budgets, conduct strategic analysis
Job Source: Johns Hopkins UniversityMemora Health Inc.
Seattle, WA, United States
Memora Health works with leading healthcare organizations to make complex care journeys simple for patients and clinicians so that care is more accessible, actionable, and always-on. Our team is rapidly growing as we expand our programs to reach more health systems and patients, and we are excited to bring on a Director, Clinical Operations. The D
Job Source: Memora Health Inc.Truveta
Seattle, WA, United States
Director of Clinical Informatics Truveta is the world's first health provider led data platform with a vision of Saving Lives with Data. Our mission is to enable researchers to find cures faster, empower every clinician to be an expert, and help families make the most informed decisions about their care. Achieving Truveta' s ambitious vision requi
Job Source: TruvetaTruveta Inc
Seattle, WA, United States
Director of Clinical Informatics Truveta is the world’s first health provider led data platform with a vision of Saving Lives with Data. Our mission is to enable researchers to find cures faster, empower every clinician to be an expert, and help families make the most informed decisions about their care. Achieving Truveta’ s ambitious vision requi
Job Source: Truveta IncGraham Contracting, Ltd.
Seattle, WA, United States
Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Graham is an employee-owned construction solutions partner that services the buildings, industrial, infrastructure, water and project finance sectors. We deliver lasting value for our clients through meticulous planning and scheduling, while upholding rigorous
Job Source: Graham Contracting, Ltd.SystImmune Inc.
Redmond, WA, United States
Director/Sr. Director of Clinical Quality Assurance 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). S
Job Source: SystImmune Inc.SystImmune Inc.
Redmond, WA, United States
Medical Director/Senior Director, Clinical ResearchRedmond, WALocated 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 sys
Job Source: SystImmune Inc.SystImmune Inc.
Redmond, WA, United States
Director/Sr. Director of Clinical Quality Assurance 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).
Job Source: SystImmune Inc.Redmond, WA, United States
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 [email protected]
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Email Alert for Associate Director/Director, Clinical Pharmacologist jobs in Redmond, WA, United States
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