Director, Clinical Development Operations

Key Responsibilities

• Provide direction and guidance to Clinical Development Operations study teams responsible for clinical trial planning, Implementation, management and close-out.
• In collaboration with the VP, Clinical Development Operations, is responsible for Clinical Operations strategy, clinical trial execution, timelines, resource planning, budget forecasting and management.
• Providing leadership within the Clinical Development Operations department, acting as a point of escalation and supporting cross-functional issue resolution, as required.
• Providing strategic, tactical and operations input to Clinical Development Teams.
• Tracking project team performance and monitoring progress toward ZW goals.
• Works closely with Clinical Finance to oversee and coordinate all budgetary activities for assigned programs including budget creation, forecasting and reporting accruals.
• Works closely with project teams to develop clinical trial protocol and associated clinical forms, including Case Report Forms, SAE Forms, etc. for assigned clinical trial.
• Review clinical sections of regulatory submission documents and assist with publications and presentation of clinical data.
• Oversees project plans and project timelines and monitors against project progress
• Provide oversight for site budget development to study teams.
• Tracks and reports study progress, risks and mitigations to cross functional department staff and senior management
• Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among study teams.
• Ensures compliance with Key Performance Indicator (KPI); Key Risk indicators (KRI); and Key quality indicators (KQI) for assigned programs.
• Prepare and follow-up of in-house and on-site quality audits, as well as, regulatory authority inspections.
• Participates in the selection, training and evaluation of study personnel (contract and internal) to insure the efficient operation of the function.
• Manages employees, monitors performance, encourages growth and facilitates the development of team members’ skills through training, mentorship opportunities and sharing of knowledge
  

Education and Experience

• University degree in a relevant discipline, and a minimum of twelve years of clinical trials experience with at least 5-7 years of management experience in pharmaceutical, biotech or CRO setting and clinical trial management experience. Preference given to candidates with experience ex-North America in either EMEA or APAC regions. Related experience in drug development, and on-site monitoring or an equivalent combination of education and experience.

Skills and Abilities

• Experience in Phase I-III clinical trials
• Experience with CRO management and outsourced clinical model
• Oncology clinical research experience required
• Strong knowledge of ICH/GCP and regulatory guidelines
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
• Strong leadership skills with the proven ability to manage, develop and empower employees
• Excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment
• Proficiency with MS Office products (MS project, Word, Excel, PowerPoint, Share point) and other electronic systems (CTMS, EDC and eTMF)
• Experience with development of eCRF required
• Ability to travel as required (up to 20%)
  

Total Rewards We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.
The US base salary range for this full-time position is $, - $, + bonus + equity + benefits. Our salary ranges are determined by role, level, and location.
The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience). Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. This role is also eligible for a competitive benefits package that includes:

• Industry leading vacation and paid time off
• Excellent health and wellness benefits
• Zymelife health and wellness benefits
• Paid time off to volunteer in your community
• Matching RRSP / K program
• Employee Share Purchase Program
• Employee Equity Program

All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.