Job Title: Associate Director, Clinical Operations

Job Number: 24047

Location: Cambridge, MA

Job Description

Goldfinch Bio seeks a motivated Associate Director (AD) of Clinical Operations to join our growing Cambridge, MA team. Reporting to the Head of Clinical Operations, the AD will partner with Clinical Development and other functions to develop feasible and clear protocol concepts and final protocols, establish the operational strategy and secure excellence in execution through Goldfinch’s CRO partnerships.  The AD will independently oversee GFB-887, the lead clinical program in Goldfinch Bio’s expanding portfolio of kidney-focused therapies (including small molecules and biologics) as part of a cross-functional team.  The AD will also manage and develop staff to ensure high-quality work performance and retention of high-quality employees.

Responsibilities

The core duties and responsibilities of this role include, but are not limited to:

  • Provide operational and implementation expertise to Goldfinch Bio’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 for that program
  • Ability to discuss & influence MD and other program team members on clinical study/program based on changing internal and external landscapes; able to think strategically to best position a study within the current Clinical Development Plan
  • Selection, oversight and management of CRO and other vendors 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 and training materials)
  • Oversight 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
  • Ensure that goals and objectives for clinical development programs are met by providing strategic and tactical input by developing study 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
  • Write and review clinical documents such as protocols, trial reports and SOPs consistent with GCPs and other applicable government and regulatory standards
  • Represent Goldfinch Bio externally to Investigators and trial site leadership
  • Lead and mentor others in the clinical development process
  • Support departmental objectives as assigned by the Head of Clinical Operations

Required Skills

  • BA/BS in a scientific field of study with 10+ years of relevant experience working in Clinical Operations in the pharmaceutical/biotech industry or a CRO
  • Rare disease clinical trial experience desired
  • In-depth understanding of industry standards and applicable guidelines; FDA regulations and ICH GCP knowledge
  • Experience in developing Clinical Operations SOPs and metrics
  • Cross-collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics/Data Management, Finance and Program Leadership
  • 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 as needed

 

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