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

The Clinical Trial Manager responsible for independently managing multiple single or multicenter clinical studies of moderate to high complexity. The CTM is expected to address site and vendor related issues, with assistance as needed. 

Key Responsibilities include but are not limited to:

  • Work closely with CMO in Developing and overseeing study plan(s)
  • Coordinates internal and external clinical development activities
  • Assists with protocol design strategy and medical issue resolution
  • Contributes significantly to relevant study documentation including project plans; implement and monitor progress against project plans and revise as necessary; review and author clinical protocols, CRF's, study reports, IB and informed consent forms with assistance as required
  • Proactively identifies project risks and resolves with minimal supervision
  • Participates in the selection of Investigators and vendors
  • Represent all cross-functional initiatives, as assigned by management, and may act on behalf of team
  • Ensure assigned studies adhere to all applicable regulations and requirements relevant to the study phase, design and/or use of data.
  • Participates in study data review and assists with patient narrative writing and other data review activities
  • Responsible for managing approved study budget(s)
  • Ensure that clinical research is cost effective by analyzing internal and external costs, resource utilization and performance data
  • Negotiate & establish contracts and budgets with external clinical sites
  • Performs other duties as assigned

Technical Skills required:

  • Strong study management track record showing clear proficiency in clinical project management skills.
  • Solid vendor management skills
  • Broad understanding of operations including those in related development functions
  • Demonstrates detailed understanding of clinical protocol, intended study populations as well as solid overall drug development
  • Demonstrates ability to effectively interface with key medical personnel at clinical site(s)
  • Demonstrates ability to lead multi-disciplinary teams
  • Demonstrates ability to flag processes that may not be appropriate for study based on phase, design, and/or use of data
  • Maintains a flexible, can-do approach to address issues proactively and innovatively
  • Possesses excellent written and oral communications skills

Additional Qualifications

  • Previous experience in radiopharmaceutical and imaging studies (diagnostic, therapeutic or both) in oncology space is required

Qualifications

  • BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy),
  • Minimum of 4-6 years clinical trial management experience in the pharmaceutical, biotech, medical device or CROs industry
  • Requires clinical research operational knowledge, strong project planning/management and effective communication skills, should be flexible and have experience and ability in managing global or regional teams in a virtual environment.
  • Proven track record in successfully managing trials from start-up to database lock. Experience with supervision of CROs/vendors is preferred.
  • Oncology therapeutic area experience is required for this position.
  • Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.
  • Must be adaptable and enjoy working in a fast-paced, growth oriented environment.
  • Effective leadership skills and proven ability to foster team productivity and cohesiveness. Computer literacy is also required.
  • Willingness to travel up to 10-20% 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
  • Apply Now

  • * Fields Are Required

    What is your full name?

    How can we contact you?

  • Sign Up For Job Alerts!

  • Share this Page
.
Fusion Logo Home About Careers Press Contact Us