The Vice President, Clinical Operations is a key leader in the organization responsible for planning, organizing, and managing the overall activities of the Clinical Operations department globally, so as to achieve all of its milestones and quality targets. The Vice President, Clinical Operations does so by communicating and promoting continuous improvement through visionary leadership to the managing team.

More specifically, the Vice President, Clinical Operations must:

• Oversee the day-to-day activities of the Clinical Operations department and support all efforts to meet departmental goals, as well as sponsor needs and requirements
• Liaise with other operational and administrative departmental heads to ensure the synergistic and optimized interaction of all cross-functional touchpoints
• Manage and coordinate efforts of the Clinical Operations department team members to support milestone achievement and optimize/resolve project-related issues
• Ensure the creation and implementation of the Clinical Operations strategic plan, as well as identify and direct (as appropriate) continuous improvement initiatives
• Support the identification and implementation of processes and training materials (including SOPS and tools) for the conduct of trials that are large in scope, global in geographic range, and complex in design, as well as be an agent of positive change within the organization
• Manage and generate departmental financial, resourcing, and KPI reports for senior management, plus hold overall P&L accountability for the Clinical Operations department operations
• Identify quality issues within the Clinical Operations department (and throughout Operations) through reviews of communications, status & financial reports, project team and department meetings, non-conformances and CAPAs, and quality assurance audit findings
• Effectively escalate quality issues, requests QA audits as appropriate, summarize findings and establish action plans to ensure resolution of quality issues for the department
• Participate in sponsor and internal quality assurance audits, as well as regulatory agency inspections as required
• Assist in the preparation of proposals for new projects, as well as in proposal defense meetings and sponsor interactions, as necessary
• Participate in departmental and/or corporate initiatives, such as plans for global growth, structure, cost containment, partnering, etc.
• Communicate effectively throughout the Clinical Operations department to ensure the vision of the Executive Committee is fully understood and incorporated into the activities and behaviors of all staff
• Create a culture of immediate action and proactive escalation to prospectively present solutions to risk, effective interaction with stakeholders, and effective management of general quality risk
• Take on Clinical Operations staff management duties including salary, interviewing candidates, terminations, career development and goals, training, and performance appraisals, as well as assists in vetting candidates for senior leadership roles throughout the organization
• Ensure adequate internal resources (i.e., headcount, experience, training) to sustain departmental activities, focus workload assignments, optimize collaboration with stakeholders, cultivate talent, and promote staff retention
• Identify and oversee the due diligence of clinical system software (as appropriate) and its implementation

IDEAL PROFILE

Education

• B.Sc. in life science or nursing; or equivalent; Master’s or advanced degree preferred

Experience 

• Experience in dermatological clinical research is an asset
• Minimum of 15 years of experience in clinical research in the biotechnology, pharmaceutical, or contract research organization (CRO) industry, including 10 years experience in clinical trial management

Knowledge and skills

• Significant experience managing teams of clinical operations professionals through complex operational global programs
• Excellent understanding of all services offered by a full-service CRO in a clinical trial (project management, medical and scientific writing, clinical trial management, clinical monitoring, data management, biostatistics, regulatory affairs, medical monitoring and pharmacovigilance)
• Significant experience in strategic planning within a CRO, as well as in setting, tracking, and adhering to departmental goals and budget
• Excellent communication skills (verbal and written in English with bilingualism in French being an asset), as well as interpersonal skills
• Excellent computer skills (Word, Excel, Powerpoint)
• Robust background in forecasting resource needs and working with Human Resources to ensure optimal plans for attracting and retaining highly talented people into the group
• Keen awareness of clinical operations systems and service providers
• Profound skill in risk identification and mitigation strategies for departmental risks
• Confidence and professionalism in dealing with sponsors and service providers about challenging and sensitive issues
• Substantial experience with business development tasks, such as development of proposals, assessing reasonable levels of clinical operations activity for project budgets, client presentations, bid defense meetings, etc.
• Ability to work in an executive environment and establish good relationships with senior colleagues as well as with sponsor organization leadership teams
• Quick learner, good adaptability and versatile
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines

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. 

As a Senior Biostatistician, 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

About Innovaderm

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. 

Innovaderm only accepts applicants who can legally work in Canada.