Immunocore
Associate Director, Clinical Operations
Immunocore, Rockville, Maryland, us, 20849
Job Details: Associate Director, Clinical Operations
Vacancy Name:
Associate Director, Clinical OperationsVacancy No:
VN365Employment Type:
Full TimeLocation of role:
Rockville, ConshohockenAbout the Company:
Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients.Key Responsibilities:Accountable for the operational delivery of one or more complex programs or studies, ensuring the program/study deliverables and milestones are met with quality and within budget.Be the key point of contact for assigned program/studies in the operational team for portfolio leaders.May participate in program strategy meetings, contributing the operational strategy of program/studies.Lead and collaborate with cross-functional teams to oversee the performance for all activities to deliver the program/study on time.Create strong strategic partnerships with colleagues in cross-functional team members to ensure consistent approaches to program/study delivery, data collection, and reporting across a program.Provide direction and support to Clinical Operations team members. Develop the program/study strategy operational plans including model scenarios for optimal program/study delivery linked to value drivers and implications on time, quality, risk, and budget.Review and provide expert Clinical Operations input into clinical documents related to the drug development process including study synopsis & protocols, clinical study reports, and all project plans.Provide regular executive updates to senior management.Oversee delivery quality, ensure inspection readiness at all times and interact regularly with Program/Study team members around issues / risks / successes with study delivery as they occur.Support study budget negotiations and management of Clinical Operations spend related to study execution.Play an active part in external service provider selections, including Contract Research Organizations (CROs) and other vendors as necessary.Work with internal and external teams as required, ensuring the programs are initiated and managed in line with company strategy and key clinical and regulatory milestones.Proactively identify and communicate program/study issues that will impact budget, resources, and timelines. Escalate as appropriate.May participate in governance committees with vendors.Other Duties:May lead and/or contribute to department initiatives and assist in the design and implementation of standardized work processes.Provide expert and collegiate support to other members of the drug development team to ensure full success of the company’s portfolio and regulatory milestones.Assist in SOP and working instruction development, review and approval.Experience & Knowledge:Essential:Worked to fully understand and apply the principles of effective clinical project practices, achieving agreed outcomes.Provided a strong clinical operational focus whilst being able to identify program needs and deliver practical, straightforward solutions.Vendor Oversight experience.Expertise in global regulatory and compliance requirements for clinical research.Demonstrated excellence in project/program management and matrix leadership.Creating and maintaining healthy relationships with study sites and principal investigators.Experience presenting high-level presentations, both orally and in writing.Ability to work independently.Ensure an enthusiastic and open attitude towards continuous professional development.Desirable:Experience with immunotherapies in Oncology would be an advantage.Education & Qualifications:BA / BS or higher in a science-related field (biological science, pharmacy, or other health-related discipline).At least 10 years relevant experience in a biotechnology/pharmaceutical industry and/or clinical research organization, including majority of time in clinical study/project management.Experience must include early phase clinical studies/Phase I-III studies and global/international studies or programs.Experience in oncology is highly desired.Demonstrated computer skills; proven functional knowledge of Microsoft packages and ability to develop proficiency in relevant Immunocore IRT and EDC systems.Work authorization and a valid passport are required for this role.
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Vacancy Name:
Associate Director, Clinical OperationsVacancy No:
VN365Employment Type:
Full TimeLocation of role:
Rockville, ConshohockenAbout the Company:
Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients.Key Responsibilities:Accountable for the operational delivery of one or more complex programs or studies, ensuring the program/study deliverables and milestones are met with quality and within budget.Be the key point of contact for assigned program/studies in the operational team for portfolio leaders.May participate in program strategy meetings, contributing the operational strategy of program/studies.Lead and collaborate with cross-functional teams to oversee the performance for all activities to deliver the program/study on time.Create strong strategic partnerships with colleagues in cross-functional team members to ensure consistent approaches to program/study delivery, data collection, and reporting across a program.Provide direction and support to Clinical Operations team members. Develop the program/study strategy operational plans including model scenarios for optimal program/study delivery linked to value drivers and implications on time, quality, risk, and budget.Review and provide expert Clinical Operations input into clinical documents related to the drug development process including study synopsis & protocols, clinical study reports, and all project plans.Provide regular executive updates to senior management.Oversee delivery quality, ensure inspection readiness at all times and interact regularly with Program/Study team members around issues / risks / successes with study delivery as they occur.Support study budget negotiations and management of Clinical Operations spend related to study execution.Play an active part in external service provider selections, including Contract Research Organizations (CROs) and other vendors as necessary.Work with internal and external teams as required, ensuring the programs are initiated and managed in line with company strategy and key clinical and regulatory milestones.Proactively identify and communicate program/study issues that will impact budget, resources, and timelines. Escalate as appropriate.May participate in governance committees with vendors.Other Duties:May lead and/or contribute to department initiatives and assist in the design and implementation of standardized work processes.Provide expert and collegiate support to other members of the drug development team to ensure full success of the company’s portfolio and regulatory milestones.Assist in SOP and working instruction development, review and approval.Experience & Knowledge:Essential:Worked to fully understand and apply the principles of effective clinical project practices, achieving agreed outcomes.Provided a strong clinical operational focus whilst being able to identify program needs and deliver practical, straightforward solutions.Vendor Oversight experience.Expertise in global regulatory and compliance requirements for clinical research.Demonstrated excellence in project/program management and matrix leadership.Creating and maintaining healthy relationships with study sites and principal investigators.Experience presenting high-level presentations, both orally and in writing.Ability to work independently.Ensure an enthusiastic and open attitude towards continuous professional development.Desirable:Experience with immunotherapies in Oncology would be an advantage.Education & Qualifications:BA / BS or higher in a science-related field (biological science, pharmacy, or other health-related discipline).At least 10 years relevant experience in a biotechnology/pharmaceutical industry and/or clinical research organization, including majority of time in clinical study/project management.Experience must include early phase clinical studies/Phase I-III studies and global/international studies or programs.Experience in oncology is highly desired.Demonstrated computer skills; proven functional knowledge of Microsoft packages and ability to develop proficiency in relevant Immunocore IRT and EDC systems.Work authorization and a valid passport are required for this role.
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