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;
- 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.
- 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.
What we offer
- Why apply through Brunel?
Finding the next step in your career can be a fulltime job in itself;
- We manage
the process for you: from submitting your resume to coordinating interviews to
extending offers and assisting with on-boarding;
- We’ll get you going while you
get on with the job.
Join the Brunel Family
- Brunel has a reputation for working with some of the best in the business;
- That’s what we continually strive for;
- Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services;
- Join us today.
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 or up-to-date LinkedIn / Xing profile
Any questions remaining?
Your consultant, Diana Grodowski is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel Canada - Toronto