Associate Director, Clinical Operations

Fusion

Posted on: February 22, 2021

Closing: March 24, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines to treat a broad range of cancers. Employing its platform technology, including proprietary Fast-Clear linker, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is growing a pipeline of precision oncology therapies in development, and recently announced a collaboration agreement with AstraZeneca. Following Fusion's June 2020 IPO, the Company has cash to fund operations into 2024.

The Associate Director of Clinical Operations is accountable for the operational strategic planning, oversight and successful delivery for one or more clinical programs. The Associate Director may lead or sponsor Clinical Operations organizational initiatives. The core duties and responsibilities of the Associate Director include, but are not limited to:

Responsibilities:

  • Provide operational and implementation expertise to Fusion's project teams to enable timely progression of clinical development programs
  • Clinical trial operational lead for clinical development program ensuring successful planning, implementation and conduct of all assigned clinical trials
  • Oversight and management of CRO to ensure timelines of clinical development plans are met
  • Work with the project team to identify and evaluate issues in the program, interpret data on complex issues and suggest and implement solutions
  • Participate in design and development of clinical trial protocols
  • Provide oversight for development of specific study documents (informed consent forms, study guidelines, operation manuals & training materials
  • Contribute and assist with the development of the clinical components of regulatory submissions
  • Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites
  • Oversee and manage clinical development program budget
  • Work on complex program issues in which analysis of situations or data require an in-depth evaluation of various factors
  • Ensure that goals and objectives for clinical development programs are met by providing strategic and tactical input by developing program specific goals, tracking metrics, producing and presenting summary reports
  • Prepare and present clinical development trial updates to project teams and management and review any potential issues or recommendations
  • Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines
  • Contribute to and review clinical documents such as protocols, trial reports and SOPs consistent with GCPs and other applicable government and regulatory standards
  • Lead and mentor others in Clinical Operations

Qualifications:

  • BA/BS in a scientific field of study with 10+ years of relevant experience working in in the pharmaceutical/ biotech industry
  • Oncology Experience Required
  • In-depth understanding of industry standards and applicable guidelines; FDA regulations and ICH GCP knowledge
  • Experience in developing Clinical Operations SOPs and metrics
  • Proven leadership experience with the desire and ability to work in a fast-paced, matrixed, start-up environment
  • Strong collaboration and team-working, communication and organizational skills required
  • Strong problem solving and analytical skills necessary
  • Ability to prioritize and manage time demand, incomplete information, and unexpected events
  • Willing to travel domestically and internationally

Fusion

Posted on: February 22, 2021

Closing: March 24, 2021

Salary($): Undisclosed

Position Type: Full Time

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