Assoc Director/Director, Clinical Operations
Bothell, WA 98012 In-Person
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Job 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
• 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 band
$172,000-$230,000
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
• 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 band
$172,000-$230,000
About Immunome, Inc.
Learn More About Immunome, Inc.Immunome is a biotechnology company that develops next-generation cancer immunotherapies. The company's proprietary discovery engine identifies novel cancer targets and develops antibody-based therapies to treat cancer. Immunome's lead product candidate, IMM-BCP-01, is a first-in-class cancer immunotherapy that targets a novel cancer antigen. The company is headquartered in Philadelphia, Pennsylvania.
