Associate Director/Clinical Scientist

Fusion

Posted on: February 22, 2021

Closing: March 24, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines to treat a broad range of cancers. Using its proprietary Fast-Clear Linker technology platform, Fusion attaches medical isotopes to targeting molecules creating novel, next-generation cancer treatments. In preclinical studies, the Company has shown the ability to precisely target and effectively kill solid tumor cells while minimizing the impact to healthy tissue. Fusion's lead program, FPI-1434, is currently in a Phase 1 trial. The Company completed an oversubscribed $125M Series B financing that will be used to advance FPI-1434 and initiate preclinical and clinical development on multiple new agents. Fusion is supported by a strong syndicate of investors and has ambitious goals to expand its pipeline.

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 NDA/BLA filing packages. Support VP, R&D Strategy on business development activities by evaluating new product potential. 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.

Duties and 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 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, efficiency is maintained
  • Set up safety review procedures: tracking of safety events, review of new SAEs, and composing adverse event narratives.
  • Assist with managing other vendor activities such as laboratory, histology or imaging. In collaboration with GDO, identifying 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, PharmaD/RN or the equivalent preferred
  • Oncology experience required.
  • At least 3-5 years previous experience in large pharma and/or biotech sectors
  • Ability to write clinical protocols
  • Ability to perform relevant literature reviews, succinctly summarize results from the literature review to support clinical program(s)
  • Analytical capabilities
  • An eye for details
  • Time management skills
  • Strong communication and interpersonal abilities
  • Ability to interact with scientists (both internal and external), clinical investigators and other experts in the field

Fusion

Posted on: February 22, 2021

Closing: March 24, 2021

Salary($): Undisclosed

Position Type: Full Time

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