Job Information
Immunocore LLC Senior Manager, Clinical Project Management in Conshohocken, Pennsylvania
About 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. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions. Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases. 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. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners. Key Responsibilities The Senior Clinical Project Manager (Sr. CPM) will be responsible for overall management and oversight of large complex contracted clinical studies and/or programs, including (but not limited to) development of project documentation, training project staff, monitoring study progress to assess protocol adherence, administration and oversight of study budgets, management of third-party vendors for clinical services and/or contract CRAs, as applicable, management of project timelines, and development of project deliverables. They will work to ensure that all aspects of the conduct of the study and/or program are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. The Sr. CPM will be asked to participate in the company's process improvement initiatives. Additionally, they could mentor Clinical Project Managers and study support staff (e.g. Clinical Trial Managers, Clinical Trial Associates) and may have direct reports (e.g. Clinical Project Managers, Clinical Trial Managers, Clinical Trial Associates) across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost, and quality. KEY RESPONSIBILITIES * Ensure successful execution and oversight of assigned programs ensuring the program deliverables and milestones are met with quality and within budget * Provide oversight and accountability of all third-party vendors assigned to a program or assigned protocol * Play an active part in CRO selection and review of RFP's when required, ensuring the appropriate CRO is identified and properly vetted. Work with internal and external teams as required, ensuring the company FIP/M development projects are initiated and managed in line with company strategy and key clinical and regulatory milestones * Review, negotiate and approve any required change orders * Develop and manage the overall study budget, forecast spend, and ensure study costs stay within predicted spend and identify and communicate study issues that will impact budget, resources and timelines * Ensure adherenc to pertinent regulatory requirements and to departmental policies, practices and procedures. Ensuring knowledge is kept up to date by reading SOP's and maintaining awareness of GCP guidelines * Ensure program meets all GCP/ICH Guidelines and is Inspection Ready * Assist and contribute in authoring company study protocols, protocol amendments and other related study documents, as required, from the initial scientific discussion * Review and approve CRFs, IRTs and other relevant specifications from a clinical perspective, ensuring the successful support of data collection * Routinely review study data and progress of EDC entry; working with data management and clinical sites to resolve data discrepancies. This includes reviewing primary and secondary efficacy and safety endpoints for inconsistency, irregularities, and/or signals * Develop and operationalize biomarker strategies, when required * Establish, monitor and maintain procedures as required to ensure regulatory compliance of protocol activities * Contribute to IND development and other regulatory documents including but not limited to briefing books, regulatory submissions and responses * Contribute high level input to regulatory documents such as Investigator's Brochures and development safety update reports (DSUR); with the ability to create and/or update these where necessary and asking for input where appropriate OTHER DUTIES * 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 within the company * If supporting a Phase FIH/P study, work closely with internal scientific, translational and clinical colleagues to deliver fit for purpose Phase I/Ib clinical studies in line with related regulatory requirements and internal quality processes * Contribute as required to the scientific, intellectual property, and business development aspects of the company's activities in order to help fully realize their potential, such as; biomarkers, trial designs, FIH study designs/operational implementation and BLA/MAA filing support SUPERVISORY RESPONSIBILITY * Manage supportive Clinical Operations function(s) (e.g., Clinical Trial Managers), by providing oversight and guidance of their task execution as required to ensure regulatory compliance of protocol activities, if appropriate * Accountable for ensuring all study deliverables and milestones are met with quality and within timelines * Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets * Provide support/escalation point for direct reports as needed Experience & knowledge Essential * Experience with Vendor oversight * Experience with all aspects of the conduct of a clinical study including start-up through close out * Familiarity with global regulatory regulations and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, GDP and ICH GCP. Awareness of local country requirements is also required * Create and maintain healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required * Ability to communicate and coordinate activities with the internal team, clinical sites and vendors * Fully understand and apply the principles of effective clinical project practices, achieving agreed outcomes * Ability to work independently * Present high-level presentations, both orally and in writing using organizational skills to complement this * Lead drug development for an assigned program * Manage multiple project functions both internally and externally, prioritizing workloads and activities to ensure projects meet critical time points and are within budget * Ensure an enthusiastic and open attitude towards continuo