- Strong track record of successfully managing clinical trials from preclinical stages through execution.
- CRO management experience.
- Extensive knowledge of clinical trial design, conduct, and regulatory requirements, including experience with regulatory submissions (e.g., IND, NDA/BLA).
- Excellent leadership, communication, and project management skills.
- Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.
-
Assoc Director/Director, Clinical Operations
1 week ago
Immunome Bothell, United StatesJob title: · Assoc Director/Director, Clinical Operations · Reporting to: · VP, Clinical Operations · Location: · Bothell, WA · About Us · Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio ...
-
Manufacturing Associate
2 weeks ago
Actalent Bothell, United States Full timeDescription: · The incumbent is responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role is responsible for performing day to day operations. · KEY ROLE AND RESPONSIBILITIES: · ...
-
Manufacturing Associate
2 weeks ago
Actalent Bothell, United States Full timeDescription: · POSITION SUMMARY: · The incumbent is responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role is responsible for performing day to day operations. Shift Schedule: W ...
-
Dental Assistant
2 weeks ago
Gentle Dental Bothell, United States Full timeAt Gentle Dental, we value our teammate's smile as much as our patient's smile. · Our vision is to provide exceptional, lifelong, integrated oral healthcare services. We enhance the quality of our patients' lives by providing accessible oral healthcare, which is paramount to ove ...
-
Dental Assistant, Ortho
2 weeks ago
Gentle Dental Bothell, United States Full timeAt Gentle Dental, we value our teammate's smile as much as our patient's smile. · Our vision is to provide exceptional, lifelong, integrated oral healthcare services. We enhance the quality of our patients' lives by providing accessible oral healthcare, which is paramount to ove ...
-
Treatment Coordinator, Ortho
2 weeks ago
Gentle Dental Bothell, United States Full timeAt Gentle Dental, we value our teammate's smile as much as our patient's smile. · Our vision is to provide exceptional, lifelong, integrated oral healthcare services. We enhance the quality of our patients' lives by providing accessible oral healthcare, which is paramount to ove ...
-
Treatment Coordinator
2 weeks ago
Gentle Dental Bothell, United States Full timeAt Gentle Dental, we value our teammate's smile as much as our patient's smile. · Our vision is to provide exceptional, lifelong, integrated oral healthcare services. We enhance the quality of our patients' lives by providing accessible oral healthcare, which is paramount to ove ...
-
Dental Hygienist
1 week ago
Gentle Dental Woodinville, United States Full timeAt Gentle Dental, we value our teammate's smile as much as our patient's smile. · Our vision is to provide exceptional, lifelong, integrated oral healthcare services. We enhance the quality of our patients' lives by providing accessible oral healthcare, which is paramount to ove ...
-
Traveling Dental Assistant, Endo
2 weeks ago
Gentle Dental Woodinville, United States$2,000 sign on bonus · At Gentle Dental, we value our teammate's smile as much as our patient's smile. · Our vision is to provide exceptional, lifelong, integrated oral healthcare services. We enhance the quality of our patients' lives by providing accessible oral healthcare, wh ...
-
Supervisor Clinic Operations
1 week ago
Swedish Edmonds, United States Full timeDescription · Provide supervisory, administrative and operational support oversight for clinic functions and special projects on a day to day basis as required. · Providence caregivers are not simply valued – they're invaluable. Join our team at Swedish Health Services DBA Swedi ...
-
Supervisor Clinic Operations
1 week ago
Providence Edmonds, United States Full timeProvide supervisory, administrative and operational support oversight for clinic functions and special projects on a day to day basis as required. · Providence caregivers are not simply valued – they're invaluable. Join our team at Swedish Health Services DBA Swedish Medical Grou ...
-
Senior Manager Clinical Operations
2 weeks ago
Theery Redmond, United StatesDuties And Responsibilities: · Develop, maintain, and manage high-quality detailed study timelines; interface regularly with study team and internal cross-functional stakeholders to ensure key activities are well-coordinated, are accurately reflected on the study- and program tim ...
-
Senior Manager, Clinical Operations
4 weeks ago
Inventprise LLC Redmond, United StatesJob Description · Job Description Salary: $140,000 - $150,000 / yearly · Title : Senior Manager, Clinical Operations · Overtime Status: · Exempt · Employment Status: · Full-Time · Pay Range: · $140,000 - $150,000 /yearly DOE · The hiring pay range for this position is $14 ...
-
Senior Manager, Clinical Operations
2 weeks ago
Inventprise Inc. Redmond, United StatesJob Description · Job DescriptionSalary: $140,000 - $150,000 / yearly · Title: Senior Manager, Clinical Operations · Overtime Status: Exempt · Employment Status: Full-Time · Pay Range: $140,000 - $150,000 /yearly DOE · The hiring pay range for this position is $140,000 - $150,000 ...
-
Manager of Clinical Operations
2 weeks ago
Vatica Health Seattle, United StatesJob Description · Job DescriptionThe Manager of Clinical Operations leads and manages the Clinical Operations teams in multiple Metropolitan Service Areas (MSAs) to ensure their efficiency, productivity, and effectiveness. The Manager of Clinical Operations collaborates with and ...
-
Director - Clinical Operations
1 week ago
Providence St. Joseph Health Seattle, United StatesLocation field must contain 'city, state' or a zip code to perform a radius search (e.g., · Denver, CO · or · City and state must be separated by a comma followed by a space (e.g., · Houston, TX ) · Providence St. Joseph Health · Director - Clinical Operations · in · Seatt ...
-
Supervisor Clinic Operations-Redmond Ridge
3 weeks ago
Providence Swedish Redmond, United StatesDescription · Provide supervisory, administrative and operational support oversight for clinic functions and special projects on a day to day basis as required. · Providence caregivers are not simply valued - they're invaluable. Join our team at Swedish Health Services DBA Swed ...
-
Supervisor Clinic Operations-Redmond Ridge
3 weeks ago
Providence Health & Service Redmond, United StatesJob Description · Provide supervisory, administrative and operational support oversight for clinic functions and special projects on a day to day basis as required. · Providence caregivers are not simply valued - they're invaluable. Join our team at Swedish Health Services DBA S ...
-
Clinical Trials Manager, Clinical Operations
3 weeks ago
Gilead Sciences, Inc. Seattle, United StatesFor Current Gilead Employees and Contractors: · Please log onto your Internal Career Site $) to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - wor ...
-
Dental Hygienist
1 day ago
Gentle Dental Kirkland, United States Full time$5,000 sign on bonus · $140,000 - $170,000 per year · We value our teammate's smile as much as our patient's smile. · Our vision is to provide exceptional, lifelong, integrated oral healthcare services. We enhance the quality of our patients' lives by providing accessible oral h ...
assoc director/director, clinical operations - Bothell, WA, United States - Immunome Inc
Description
Job title: Assoc Director/Director, Clinical Operations
Reporting to:
VP, Clinical Operations
Location: Bothell, WA
About Us
Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies.
Our portfolio pursues each target with a modality appropriate to its biology, including immunotherapies, targeted effectors, radioligand therapies and antibody drug conjugates (ADCs).
We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies.Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.
Position summary
We are seeking an accomplished and results-driven professional Director, Clinical Operations will be responsible for overseeing the planning, implementation, and management of clinical trials, ensuring adherence to timelines, budgets, and quality standards.
This individual will play a key role in driving the successful progression of our clinical development programs to lead our dynamic team in advancing our pipeline of innovative targeted cancer therapies.
Key Responsibilities
Clinical Trial Oversight:
Lead the development of comprehensive clinical trial plans, including study protocols, timelines, clinical study budgets, and resource allocation, in collaboration with cross-functional teams.
Provides senior level operational review of protocols and study plans.Identify potential risks and issues related to clinical trial conduct and develop mitigation strategies to minimize impact on timelines and outcomes.
Clinical Operations Leadership:
Build and lead a high-performing clinical operations team, providing guidance, mentorship, and support to ensure successful trial execution and achievement of objectives.
Manage, develop, and mentor team members. Establish strategic vision and long-range planning for clinical operations. Develop SOPs and processes in partnership with other functions.Quality Assurance:
Provide technical guidance and expertise to ensure compliance with regulatory requirements, GCP guidelines, and company SOPs throughout the clinical trial lifecycle, conducting regular audits and implementing corrective actions as needed.
Vendor Management:
Manage relationships with external vendors, including contract research organizations (CROs), central laboratories, and other service providers, to ensure efficient and effective trial conduct.
Data Management and Analysis:
Work closely with data management and biostatistics teams to oversee the collection, analysis, and interpretation of clinical trial data, ensuring accuracy and integrity.
Cross-Functional Collaboration: Collaborate closely with clinical development, regulatory affairs, medical affairs, and other stakeholders to ensure alignment and integration of clinical trial activities.
Requirements
Educational and experience requirements
Bachelor's degree required, or at least a minimum of 8 years of industry experience in clinical operations within the biopharmaceutical industry.
Qualifications
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Salary band
$172,000-$230,000