Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. We are developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs.
It is an exciting time to join Immunocore. Our most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies. The company also recently completed its Initial Public Offering and was listed on the NASDAQ.
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) across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality.
This position is located in the Conshohocken, PA office.
- 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 iidentify and communicate study issues that will impact budget, resources and timelines
- Ensure adherence 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
- 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
- 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 continuous professional development
- Provide a strong clinical operational focus whilst being able to identify program needs and deliver practical, straight-forward, solutions which work first time
- Proactively design and deliver optimized Phase I/Ib clinical protocols
- Project/program management and matrix leadership
- Knowledge of and experience with immunotherapies, infectious disease and/or Oncology therapeutic discipline
- Previous experience contributing to INDs
Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.