The Clinical Program Director, Early Phase will support the Director of Early Phase and Translational Research Department in oversight of department and study activities to ensure good study health and data quality. In addition, the Clinical Program Director will contribute to proposal development and business development activities at a project level, and actively perform study activities.

This role will be perfect for you if:

• you have at least 7 years of Phase 1-2a clinical trial planning and oversight and at least 5 years of experience in a CRO or pharmaceutical company
• you have significant experience in tracking and adherence of project scope and budget
• you have profound skill in risk identification and mitigation strategies for clinical trial delivery
• you are a hands-on leader with open-minded approach, ready to take responsibility, provide input, mentor/ learn from others.

RESPONSIBILITIES

More specifically, the Clinical Program Director, Early Phase:

• Keeps abreast of early development industry best practices, as well as constantly develops and oversees process improvement initiatives
• Ensures adequate training and the right level of operational standardization of the Early Phase and Translational Research Department
• Participates in due diligence of clinical systems software and its implementation
• Creates the appropriate forum(s) to identify study issues and implements strategies to ensure projects are as successful as possible
• Manages reported and observed quality issues at department- and study-level, and establishes action plans to ensure their resolution
• Serves as a senior point of contact for sponsors when issues must be escalated to ensure communication is maintained and resolution is achieved
• Serves as a senior point of contact for department team for operational questions
• Leads and ensures consistency in contingency planning and risk mitigation strategies to ensure successful delivery
• Conducts study activities (approximately 0.5 FTE)
• Ensures that projects are completed to the sponsor’s satisfaction, ensuring quality deliverables on time, within scope, within budget and in accordance with applicable standard operating procedures (SOPs), regulatory guidelines, and good clinical practices (GCP)
• Manages and generates project financial, resourcing, and KPI reports for senior management
• Participates in the preparation of budgets and proposals in response to requests for proposals from potential sponsor partners
• Participates in proposal defense meetings and sponsor interactions, as necessary
• Participates in sponsor audits as well as regulatory agency inspections
• Participates in functional and/or corporate initiatives and special project assignments

IDEAL PROFILE

Education 

• Master of Science in a relevant discipline
• PhD is an asset
• PMP Certification is an asset

Experience 

• Dermatology experience is a requirement
• At least 7 years of Phase 1-2a clinical trial planning and oversight (experience in SAD-MAD is an asset)
• At least 5 years of experience in a CRO or pharmaceutical company
• Substantial experience in project supervision, mentoring and coaching
• Significant experience in tracking and adherence of project scope and budget, identifying opportunities for Change Orders, and liaising with sponsors about financial issues
• Substantial experience with business development tasks, such as development of proposals, assessing reasonable levels of activity for project budgets, client presentations, bid defense meetings, and the like
• Clinical experience (e.g. CRA, CTM, CRC)is a strong asset

Knowledge and skills

• Robust knowledge of good clinical practices, along with applicable Health Canada, Food and Drug Administration (FDA), as well as European Medicines Agency (EMA) regulations/guidelines
• Confidence and professionalism in dealing with sponsors about challenging and sensitive project execution issues originating from within or without the organization
• Profound skill in risk identification and mitigation strategies for clinical trial delivery
• Keen awareness of clinical systems and service providers including but not limited to CTMS, eTMF, IRT, Quality, etc.

OUR COMPANY

The work environment

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks: 

• Flexible work schedule
• Permanent full-time position
• Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
• Ongoing learning and development