Invivyd, Inc
Senior Director, Head of Clinical Operations New Haven, CT (Northeast preferred)
Invivyd, Inc, New Haven, Connecticut, us, 06540
Overview
Senior Director, Head of Clinical Operations – New Haven, CT (Northeast preferred). Hybrid role with a mix of onsite (New Haven, CT) and remote working. Invivyd, Inc. is focused on delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2, with a proprietary platform to assess, monitor, develop, and adapt antibodies. The role reports to the Head of Clinical Development and provides strategic operational guidance to ensure clinical trials are properly planned and executed across all clinical stage programs, overseeing all aspects of clinical trial execution, including GCP compliance. Responsibilities
Oversee study management activities for global monoclonal antibody clinical research studies Manage clinical trial activities on specified studies and oversee local and global CROs Lead selection and management of external vendors; develop vendor specifications; review vendor reports, budgets, forecasts, and metrics Review and negotiate contracts Forecast costs for clinical studies Review and approve invoices against approved budgets and contracts Monitor subject accrual and study progress via standard reports Oversee clinical monitoring from site qualification to site closure; ensure data integrity and documentation through monitoring reports and case report forms Update program team and Clinical Operations management on timelines and milestone progress Apply Invivyd and industry standards across research programs Provide guidance to Clinical Operations Leads in vendor and investigator oversight to ensure protocol compliance and study objectives Collaborate with study leads to establish performance and quality metrics for the study and report metrics that drive quality and efficiency Work with Clinical Operations/Development management to ensure timely, in-budget completion of department goals in line with SOPs Support departmental initiatives aimed at innovation, process improvement, and efficiency Develop or contribute to key vendor oversight plans and processes Assist with developing SOPs, work instructions, and standardized forms for Clinical Department processes Collaborate with Clinical, Regulatory, Safety, Quality, and other functions to ensure compliance with FDA regulations, ICH GCP, and Invivyd SOPs Ensure GCP compliance by guiding study leads and study teams Support activities related to QA audits; assist with audit responses and CAPA tracking Manage direct reports, as applicable Limited travel (
Qualifications
Bachelor’s degree with 10-15 years of relevant experience Strong oral and written communication skills Experience with development and maintenance of study timelines and budgets Highly adaptable, proactive, deadline- and detail-oriented Professional expertise with good clinical practice and risk-based quality management Ability to work in a fast-paced and dynamic environment Ability to accommodate a hybrid schedule with onsite presence in New Haven, CT (on-site at least monthly; more frequent is preferred) Invivyd is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected characteristics. Note:
We do not accept unsolicited resumes from agencies.
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Senior Director, Head of Clinical Operations – New Haven, CT (Northeast preferred). Hybrid role with a mix of onsite (New Haven, CT) and remote working. Invivyd, Inc. is focused on delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2, with a proprietary platform to assess, monitor, develop, and adapt antibodies. The role reports to the Head of Clinical Development and provides strategic operational guidance to ensure clinical trials are properly planned and executed across all clinical stage programs, overseeing all aspects of clinical trial execution, including GCP compliance. Responsibilities
Oversee study management activities for global monoclonal antibody clinical research studies Manage clinical trial activities on specified studies and oversee local and global CROs Lead selection and management of external vendors; develop vendor specifications; review vendor reports, budgets, forecasts, and metrics Review and negotiate contracts Forecast costs for clinical studies Review and approve invoices against approved budgets and contracts Monitor subject accrual and study progress via standard reports Oversee clinical monitoring from site qualification to site closure; ensure data integrity and documentation through monitoring reports and case report forms Update program team and Clinical Operations management on timelines and milestone progress Apply Invivyd and industry standards across research programs Provide guidance to Clinical Operations Leads in vendor and investigator oversight to ensure protocol compliance and study objectives Collaborate with study leads to establish performance and quality metrics for the study and report metrics that drive quality and efficiency Work with Clinical Operations/Development management to ensure timely, in-budget completion of department goals in line with SOPs Support departmental initiatives aimed at innovation, process improvement, and efficiency Develop or contribute to key vendor oversight plans and processes Assist with developing SOPs, work instructions, and standardized forms for Clinical Department processes Collaborate with Clinical, Regulatory, Safety, Quality, and other functions to ensure compliance with FDA regulations, ICH GCP, and Invivyd SOPs Ensure GCP compliance by guiding study leads and study teams Support activities related to QA audits; assist with audit responses and CAPA tracking Manage direct reports, as applicable Limited travel (
Qualifications
Bachelor’s degree with 10-15 years of relevant experience Strong oral and written communication skills Experience with development and maintenance of study timelines and budgets Highly adaptable, proactive, deadline- and detail-oriented Professional expertise with good clinical practice and risk-based quality management Ability to work in a fast-paced and dynamic environment Ability to accommodate a hybrid schedule with onsite presence in New Haven, CT (on-site at least monthly; more frequent is preferred) Invivyd is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected characteristics. Note:
We do not accept unsolicited resumes from agencies.
#J-18808-Ljbffr