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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.
The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.
The Associate Director, Clinical Scientist will collaborate with cross-functional teams (Clinical Development, Clinical Operations, R&D, CMC, etc.) on designing and writing clinical study synopses and protocols, Investigator Brochures, and clinical study reports; review SAPs and TLF shells; participate in emerging clinical trial data evaluation and interpretation; ensure that assigned studies are conducted according to GCPs and Fusion’s SOPs; conduct literature searches and reviews, meta-analyses, and publishing data; oversee the review of clinical study entries (clinical trial information and results) for posting to www.clinicaltrials.gov (clinical trial registry and results database) and/or a TPR (Third Party Registry); and assist in preparation of IND/NDA/BLA filing packages. The span of responsibilities is broad and may support one or several clinical programs depending on their size and complexity. The incumbent will liaise with various vendors, and study investigators at participating sites.
Responsibilities
- Member of the cross-functional clinical trial team for assigned studies
- Participate in review of clinical and scientific data and developing product knowledge to understand and communicate the relevant information
- Participate in development and review of clinical study documents (e.g., protocols and protocol amendment(s), informed consent documents, case report forms).
- Support activities related to the start-up and execution of new clinical trials.
- Contribute relevant clinical sections to documents such as the IB, DSUR, INDs or CSRs
- Responsible for clinical data review and drafting reports and presentations on the various findings of the clinical research, including abstracts, posters, publications
- Provide support with the activities related to the execution, monitoring, and reporting of clinical trials
- Perform regular review of clinical data to ensure that the study is conducted in accordance with the protocol, safety procedures are followed, and efficiency is maintained
- Assist with safety review procedures: tracking of safety events, review of new SAEs, and composing/editing adverse event narratives
- Assist with managing other vendor activities such as laboratory, histology or imaging. In collaboration with clinical operations, identify clinical sites and CROs that will participate in trials. Interact with staff responsible for the design, set-up, execution, analysis and reporting of these studies.
Qualifications
The Associate Director, Clinical Scientist must hold a Bachelor of Science degree from an accredited educational institution. Additional training in bio life sciences with an advanced master's qualifications is preferred. Training through internships that provide knowledge on ICH, GCP, and other relevant regulatory guidelines is advantageous.
- PhD, PharmD/RN or the equivalent preferred
- Oncology experience required
- At least 3-5 years previous experience in large pharma and/or biotech sectors
- Experience writing clinical protocols, including background and rationale sections
- Experience performing relevant literature reviews, and ability/experience in succinctly summarizing results to support the study/dosing rationale(s)
- Analytical capabilities
- Careful attention to detail
- Clinical data review experience is required
- Ability to manage multiple deadlines
- Strong communication and interpersonal abilities
- Experience interacting with scientists (both internal and external), clinical investigators and other experts in the field
- Prior experience working on partnered programs, though not essential, would be preferred
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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