Associate Director of Clinical Operations

Location
San Diego, California or Calgary, Canada
Salary
Competitive salary and benefits package offered
Posted
Jun 10, 2019
Required Education
Bachelors Degree
Position Type
Full time

Position Summary

Oncolytics Biotech Inc. is a biopharmaceutical company developing pelareorep, a safe and well-tolerated intravenously delivered immuno-oncolytic virus (IOV) that kills cancer.  We are currently seeking a qualified and experienced individual for the position of Associate Director of Clinical Operations based in either San Diego, California, or Calgary, Canada.

The successful candidate will have the skills and experience necessary to thrive in a dynamic and growing company environment, as he/she directs the planning, execution, monitoring and completion of all clinical trials.  The Associate Director will build relationships and interact with Contract Research Organizations and academic groups, external physician investigators and other contracted service providers.  This person will act as the clinical operation lead on all clinical trials. This individual will also participate in cross-functional projects, interacting closely with other Oncolytics team members and departments.  The Associate Director will be expected to be solution-oriented and plan and participate in the execution of all aspects of clinical projects.

Essential Duties & Responsibilities

  • In collaboration with internal and external scientific and medical experts, manage the execution of phase 1-3 clinical trials in an out-sourced model from study start-up to final clinical study report
  • Author, review and/or manage a wide variety of activities, including for example, clinical trial synopses, protocols, case report forms, investigator brochures, and the like; manage internal teams to review and approve clinical study reports in accordance with overall project timelines
  • Prepare Request for Proposal documents and with cross-functional project team, solicit and evaluate bids; lead contracting process with selected CROs/ academic groups, collaborating with relevant departments such as Legal, Finance, and Business Development.
  • Manage CROs or collaborate with academic groups to execute clinical trials in accordance with contracted scope, costs and timelines; actively engage with academic groups/CROs on defining, monitoring and reporting on all aspects of key trial performance indicators, including for example, country and site initiation activities, patient screening and randomization rates, and data collection activities
  • Interact with investigators and sites as needed to support academic groups/CROs and ensure clinical trials are conducted according to plan
  • Identify and track trial risks and issues, proactively escalate risks to internal and academic groups/CRO teams, develop and implement risk mitigation strategies and tactics
  • Provide oversight and input to additional study-related external vendors, including execution of work and tracking of milestones and deliverables
  • Plan and manage budget proposals and approved budgets
  • Assist with Standard Operating Procedure (SOP) development and implementation
  • Contribute to wider organizational goals and/or activities as assigned
  • Select and manage data management vendors throughout the clinical trial process, including activities required for database lock and generation of data presentations
  • Other duties as assigned

Core Competencies, Knowledge and Skill Requirements

  • Knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials
  • Knowledge of how to run GCP-compliant phase 1-3 trials from start up to close out, where multiple stakeholders and vendors are involved
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description  
  • Comfortable operating in a fast-paced, dynamic, small company environment with minimal direction. Able to adjust workload based upon changing priorities
  • Demonstrated proficiency in applicable software applications, to include MS Office programs (Word, Excel, PowerPoint, Project), and commonly used document management system(s)
  • Strong interpersonal skills and professional attitude are essential as this individual interacts with many people of varying levels of responsibility for clinical studies and business performance

Communication & Interpersonal Skills

  • Excellent verbal and written communication skills
  • Must be able to write clearly and summarize information effectively
  • Excellent influencing and negotiation skills
  • Proven ability to manage multiple projects and complex timelines in a team environment
  • Strong communication (oral and written), analytical and organizational skills

Desired Background and Experience

  • Experience in phase 1-3 clinical studies is required. Experience in oncology a plus
  • Global trial and CRO management experience is preferred
  • Experience working with academic groups
  • Experience creating and/or reviewing monitoring reports and monitoring visit letters is required
  • Knowledge of US and EU laws and guidelines required. Expertise with other international pharmaceutical guidelines and regulations a plus
  • Required to be based in either San Diego, California, or Calgary, Canada (no exceptions allowed)

Education

  • BS degree (MSc preferred) and a minimum 8 years in a Clinical Operations/Trial role in the biotech/pharmaceutical industry

Other

  • Travel up to 15% may be required
  • Job Type: Full-time