Associate Director, Clinical Operations

• 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.

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.

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