Fusion Pharmaceuticals
  • Boston, MA, USA
  • Full Time

Company Profile:

Fusion Pharmaceuticals is a newly formed biopharmaceutical company discovering and developing targeted alpha-particle radiotherapeutics for treating cancer.  Targeted alpha-particle emitting radiotherapeutics combine the precision of molecular targeting agents, such as antibodies, with the potency of alpha-particle emitting radioisotopes to specifically attack and eradicate cancer cells.

This position is targeted to be based in the Boston area, USA

Your responsibilities include but are not limited to:

  • The preferred applicant shall have experience beyond research and have experience in both clinical studies and publications
  • Clinical development plans and study protocols, analysis of clinical data, writing clinical study reports and providing scientific consultation and expertise throughout clinical product development.
  • Review of scientific and medical literature relevant to product therapeutic areas.
  • Participate in development and continuous improvement of processes and workflows
  • Lead in the design and writing of clinical study protocols and programs.
  • Writes clinical study reports and scientific publications by interpreting and analyzing study data
  • Ensures that studies are conducted to meet timelines
  • Provides scientific input on disease indications, trial designs and scientific rationale for relevant compounds within specific therapeutic areas
  • Performs literature searches and coordinates scientific discussions relevant for designing study protocols, interacting efficiently with internal/external collaborators to ensure the trial design is in line with current regulatory and scientific requirements
  • Participates in the development, implementation, conduct and reporting of clinical trials, keeping up-to-date with the preclinical and clinical data relevant to the investigational product(s)
  • Knowledge of conducting clinical trials in a regulated environment
  • Provides ongoing critical evaluation of development strategies to maintain state-of-the-art clinical development plans that are competitive and consistent with the latest regulatory requirements; proactively identifies challenges and develops contingency plans to mitigate
  • Participates in the monitoring and interpreting of data from an overall scientific standpoint, assessing the scientific implications and making recommendations that can impact clinical development
  • Generates and reviews clinical and regulatory documents and ensures quality submissions to the Health Authorities; participates in discussions with the Health Authorities where needed
  • Monitors safety during the conduct of clinical trials, assessing for potential trends or safety signals
  • Establishes and maintains appropriate collaborations and relationships with external scientific experts, thought leaders and the general medical community
  • Assists in the development of standard operating procedures (SOPs) and guidelines linked with departmental activities
  • Performs related duties as assigned

Qualifications and Experience:

  • Sc. or Ph.D. in a relevant discipline
  • At least 2 to 3 years of experience in a clinical scientist capacity within the pharmaceutical and/or biotech industry
  • Experience in clinical research, studies and publications
  • Relevant experience in writing clinical documents such as study protocol and study reports
  • Excellent writing and communication skills in English are essential
  • Must be adaptable and enjoy working in a fast-paced, growth oriented environment.
  • Knowledge and understanding of Good Clinical Practice, ICH guidelines and the regulatory landscape in the United States, Canada and Europe preferred
  • Attentive to details; good initiative and able to work collaboratively in dynamic small teams of internal and external partners in a fast-paced environment with changing priorities under tight timelines
  • Experience in radiopharmaceuticals is considered an asset
  • Experience with imaging is considered an asset
  • Willingness to travel up to 10% of time

 

If you require accommodation for your application or interview, please contact Human Resources directly at 905.525.9140 ext. 21112 or by email at careers@imagingprobes.ca

 

We thank all those who apply but only candidates selected for interviews will be contacted.

 

Fusion Pharmaceuticals
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