Immunome, Inc.
Sr Manager, Clinical Operations
Immunome, Inc., Bothell, Washington, United States, 98021
Description:Job title:
Sr Manager, Clinical Operations
Company:
Immunome, Inc.
Reporting to:
Assoc Director, Clinical Operations
Location:
Bothell, WA
Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025.
Position Overview:
We are seeking an accomplished and results-driven professional Sr Manager, Clinical Operations who will be responsible for overseeing the planning, implementation, and management of clinical trials, ensuring adherence to timelines, budgets, and quality standards.
Key Responsibilities :
Clinical Trial Oversight :
Lead the development of comprehensive clinical trial plans, including study protocols, timelines, clinical study budgets, 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.
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:Education:
Bachelor’s degree in life sciences or a related field.
Professional Experience : minimum of 5 years of industry experience in clinical operations within the biopharmaceutical industry.
Knowledge and Skills:
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.
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 Range
$160,000 - $190,000
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Sr Manager, Clinical Operations
Company:
Immunome, Inc.
Reporting to:
Assoc Director, Clinical Operations
Location:
Bothell, WA
Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025.
Position Overview:
We are seeking an accomplished and results-driven professional Sr Manager, Clinical Operations who will be responsible for overseeing the planning, implementation, and management of clinical trials, ensuring adherence to timelines, budgets, and quality standards.
Key Responsibilities :
Clinical Trial Oversight :
Lead the development of comprehensive clinical trial plans, including study protocols, timelines, clinical study budgets, 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.
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:Education:
Bachelor’s degree in life sciences or a related field.
Professional Experience : minimum of 5 years of industry experience in clinical operations within the biopharmaceutical industry.
Knowledge and Skills:
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.
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 Range
$160,000 - $190,000
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