Associate Director, Clinical Operations

PUB293955

About this role

  • Our client who is a clinical-stage oncology company is seeking an Associate Director of Clinical Operations as they grow the team in Boston Massachusetts.

  • 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 the company 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.

Requirements

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.

Benefits

What we offer

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Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
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Any questions remaining?

Your consultant, Diana Grodowski is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB293955

Account manager

Diana Grodowski
Brunel Canada - Toronto
d.grodowski@brunel.net

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