Fusion Pharmaceuticals US Inc
Director, Clinical Operations
Fusion Pharmaceuticals US Inc, Boston, Massachusetts, us, 02298
Fusion Pharmaceuticals, a member of the AstraZeneca Group,
is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.
Reporting into the VP, Clinical Operations, the Director, Clinical Operations is accountable for the operational strategic planning, oversight and successful delivery for one or more clinical trials/programs.
Responsibilities:
Provide operational and implementation expertise to Clinical Operations trial team(s) to enable timely progression of clinical development programs
Function as Clinical Operations lead for clinical development program(s) ensuring successful planning, implementation and conduct of all assigned clinical trials
Lead selection process of CRO, including generation of Request for Proposal; perform and document Sponsor-level oversight and management of CRO (or collaboration partner) for outsourced activities
Work with the cross-functional project team to identify and evaluate issues in the program and suggest and implement solutions
Contribute to design, development and review of clinical documents such as protocols, investigator brochures, trial reports and other trial related documents
Provide oversight for development of trial-specific documents (e.g. informed consent forms, study plans/guidelines, operation manuals & training materials)
Contribute to and assist with the development of the clinical components of regulatory submissions
Maintain oversight and participation in creation/review/training/maintenance of departmental and organization SOPs to ensure compliance
Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites
Oversee and manage Clinical Operations program budget
Evaluate CRO, site and study performance metrics against agreed upon trial budget, deliverables and timelines
Ensure that goals and objectives for clinical development programs are met by providing strategic and tactical input by developing program specific goals, managing timelines, tracking metrics, producing and presenting summary metrics/reports
Prepare and present clinical trial updates to project teams and management and review any potential issues or recommendations
Oversee and manage direct reports with regular meetings and mid-year/end-year review processes
Lead and mentor junior Clinical Operations team members
Qualifications:
BA/BS in a scientific field of study with a minimum of 8 years of relevant experience working in in the pharmaceutical/ biotech industry, including at least 4 years of clinical trial management experience and full trial life-cycle experience (e.g. start up to closeout)
Multi-dimensional Clinical operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning etc.
Experience in Oncology required
In-depth understanding of industry standards and applicable guidelines including FDA regulations and ICH GCP guidelines
Experience in developing Clinical Operations SOPs and trial metrics
Proven team leadership experience with the desire and ability to work in a fast-paced, matrixed, start-up environment
Strong cross-functional collaboration proficiency
Excellent communication and organizational skills
Strong problem solving and analytical skills
Ability to be flexible, work independently and prioritize workload
Willing to travel domestically and internationally
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.
Reporting into the VP, Clinical Operations, the Director, Clinical Operations is accountable for the operational strategic planning, oversight and successful delivery for one or more clinical trials/programs.
Responsibilities:
Provide operational and implementation expertise to Clinical Operations trial team(s) to enable timely progression of clinical development programs
Function as Clinical Operations lead for clinical development program(s) ensuring successful planning, implementation and conduct of all assigned clinical trials
Lead selection process of CRO, including generation of Request for Proposal; perform and document Sponsor-level oversight and management of CRO (or collaboration partner) for outsourced activities
Work with the cross-functional project team to identify and evaluate issues in the program and suggest and implement solutions
Contribute to design, development and review of clinical documents such as protocols, investigator brochures, trial reports and other trial related documents
Provide oversight for development of trial-specific documents (e.g. informed consent forms, study plans/guidelines, operation manuals & training materials)
Contribute to and assist with the development of the clinical components of regulatory submissions
Maintain oversight and participation in creation/review/training/maintenance of departmental and organization SOPs to ensure compliance
Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites
Oversee and manage Clinical Operations program budget
Evaluate CRO, site and study performance metrics against agreed upon trial budget, deliverables and timelines
Ensure that goals and objectives for clinical development programs are met by providing strategic and tactical input by developing program specific goals, managing timelines, tracking metrics, producing and presenting summary metrics/reports
Prepare and present clinical trial updates to project teams and management and review any potential issues or recommendations
Oversee and manage direct reports with regular meetings and mid-year/end-year review processes
Lead and mentor junior Clinical Operations team members
Qualifications:
BA/BS in a scientific field of study with a minimum of 8 years of relevant experience working in in the pharmaceutical/ biotech industry, including at least 4 years of clinical trial management experience and full trial life-cycle experience (e.g. start up to closeout)
Multi-dimensional Clinical operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning etc.
Experience in Oncology required
In-depth understanding of industry standards and applicable guidelines including FDA regulations and ICH GCP guidelines
Experience in developing Clinical Operations SOPs and trial metrics
Proven team leadership experience with the desire and ability to work in a fast-paced, matrixed, start-up environment
Strong cross-functional collaboration proficiency
Excellent communication and organizational skills
Strong problem solving and analytical skills
Ability to be flexible, work independently and prioritize workload
Willing to travel domestically and internationally
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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