Associate Director, Clinical Operations

Leap Therapeutics is seeking motivated individuals with clinical operations experience to be part of a growing oncology company.  Successful candidates will work within a highly collaborative team environment to assist in developing and implementing operational plans designed to meet project timelines and the company’s business objectives.

 

Associate Director

Reports to the Director 

The candidate must have prior experience managing global clinical studies, CROs and vendors within a sponsor company.  They must have prior experience managing complex clinical projects and providing direction and oversight to study team.  A thorough understanding of FDA regulations, GCP and ICH are required along with strong interpersonal and organization skills.  Attention to detail is imperative.

Responsibilities

Associate Director (AD), Clinical Operations, supports the operational aspects of clinical studies through providing direction for clinical trial execution through the oversight of trial managers. The AD may be responsible to manage their own assigned clinical studies. They also will support and participate in development and implementation of process improvement activities and training trial managers.

Specific responsibilities include:

  • Provide leadership and mentoring to trial managers; perform technical support to ensure that they have required knowledge to fulfill their duties

  • Support the operational aspects of global clinical operations by overseeing trial managers and providing direction and guidance

  • Monitor performance by close interaction with trial managers, CROs, vendors and consultants

  • Responsible for development of CRO and vendor oversight plans

  • Perform and monitor oversight for responsible study(ies) to ensure trials and relevant program related activities are in adherence to ICH, GCP and Sponsor SOPs

  • Develop and oversee study quality metrics to ensure that subject recruitment goals are met

  • Identify and communicate study issues that will impact budget, resources and timelines

  • Assist in developing and implementing training plans and creating study tools

  • Make recommendations to Director regarding promotional and developmental opportunities

  • If assigned clinical study(ies), drive all aspects of clinical trial management and processes from initiation, planning, execution, maintenance and close-out.

  • Assist in the development of clinical trial budgets; support efforts to revise budget forecast as needed; develop and maintains study budget tracking tools to ensure that trial costs are accurately tracked and reported.

  • Participate in data reviews, as needed

  • Assist with the development of the clinical components of regulatory submissions including, but not limited to safety, interim and final study reports

  • Serve as an escalation point and resource for internal and external team members

  • Partner with cross functional groups to achieve deliverables

  • Participate in the development, review and implementation of departmental SOPs and processes.

  • Contribute to cross-functional operational excellence efforts through process improvements related to systems and processes

 

Education / Experience / Skills:

  • Bachelor's degree in life science plus at least 10 years clinical research experience within the pharmaceutical/Biotechnology industry

  • Minimum of 7 years of clinical trial management experience, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance

  • Experience with oncology studies preferred.

  • Working knowledge of FDA regulations and ICH GCP guidelines.

  • Demonstrate leadership skills to motivate and mentor team and to facilitate and prioritize tasks and/or work independently

  • Experience with managing CROs, vendors and consultants

  • Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting

  • On-site monitoring experience

  • Strong interpersonal and communication skills (verbal and written)

  • Good organizational and time management skills

Willing to travel (up to 20%) post COVID-19

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