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Senior Director, Clinical Trials Performance & Head of Operations, SPHERE CRO

  • Toronto, ON, Canada
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Job details

Posting language
English
Posted

Original job description

Unity Health Toronto

Senior Director, Clinical Trials Performance & Head of Operations, SPHERE CRO

Toronto, ON (hybrid)

Unity Health Toronto is one of Canada’s largest Catholic healthcare networks serving patients, residents and clients across the full spectrum of care, spanning primary care, secondary community care, tertiary and quaternary care services to post-acute through rehabilitation, palliative care and long-term care, while investing in world-class research and education.

Research is a cornerstone of Unity Health Toronto’s mission, bringing together world-class scientists, clinician-researchers, trainees, and research staff to advance discoveries that improve patient care and strengthen health systems. With internationally recognized strengths across clinical, scientific, and population health research, Unity Health is committed to translating innovative research into meaningful impact for patients, communities, and the broader healthcare system.

THE OPPORTUNITY

Clinical trials are a key part of Unity Health Toronto's Exceptional Care Without Exception strategic plan, advancing research excellence across the network while providing patients with access to innovative therapeutics that may not otherwise be available. SPHERE CRO, one of Canada's leading academically-affiliated Contract Research Organizations (CRO), complements this work by delivering end-to-end clinical research services to academic, pharmaceutical, biotechnology, and industry partners, including site management, project management, data management and technologies, regulatory affairs, biostatistics, and patient engagement.

A newly-created role reporting to the Chief Operating Officer, Research, and overseeing a team of approximately 50 people, the Senior Director will lead the execution of Unity’s clinical trials strategy, including the build of the Central Clinical Trials Unit, the adoption of key technologies such as the enterprise deployment of the clinical trials management system, and initiatives that position Unity’s sites as a global leader in clinical trials performance. The Senior Director will also lead the Industry Preferred Partnership Model, further fostering relationships with existing global pharmaceutical partners while pursuing new partnerships aligned with Unity’s clinical trials strategy. In addition, the role will oversee the financial and operational performance of SPHERE CRO, with full accountability for business development, client relationships, strategy, operations, and Profit and Loss (P&L) oversight.

QUALIFICATIONS AND EXPERIENCE

  • 10+ years of senior leadership experience in strategy and operations with a pharmaceutical portfolio including focus on research and development, biotechnology, or contract research organization (CRO).
  • MBA, Master of Science, or equivalent degree in a related field.
  • Demonstrated success building or transforming a clinical trials enterprise in partnership with global industry partners.
  • Experienced in successfully negotiating master agreements with global or large industry clients.
  • Demonstrated success operating a CRO or similar life sciences organization with regional or global studies to meet the needs of academic, industry and non-government organizational clients.
  • Demonstrated ability in leading business development or sales function of life sciences organizations, particularly related to a CRO.
  • Deep knowledge of ICH-GCP, Health Canada, FDA, EMA and applicable regulatory frameworks.
  • Experienced in managing large portfolio budgets including forecasting resourcing demands, pricing and profitability analysis, and variance analysis.
  • Superior interpersonal, influencing, and stakeholder relationship skills to foster alignment, goal congruence, and enthusiasm across clinical, institutional, and industry stakeholders.

Unity Health Toronto is committed to creating an accessible and inclusive organization. We strive to provide a recruitment process that is barrier-free and in compliance with the Accessibility for Ontarians with Disabilities Act (AODA) and the Ontario Human Rights Code. Should you require accommodation to participate as a candidate in the hiring process, please communicate your needs to the LHH Knightsbridge project team.

The Senior Director, Clinical Trials Performance & Head of Operations, SPHERE CRO is a current existing vacancy. LHH Knightsbridge does not use artificial intelligence (AI) to screen, assess, or select applicants for a position.

More about this job

Responsibilities

The Senior Director at Unity Health Toronto will lead clinical trials strategy, build the Central Clinical Trials Unit and manage SPHERE CRO's business development, client relationships and profit and loss. The role also leads industry partnerships and oversees a team of about 50 people.

Requirements

Candidates need 10+ years of senior strategy and operations leadership in pharma, biotech or a CRO, plus a graduate degree such as an MBA or MSc. They must know ICH-GCP, Health Canada, FDA and EMA rules, and manage large budgets and master agreements with global clients.

Skills

  • Clinical trials management system (CTMS) deployment
  • ICH-GCP
  • Health Canada regulations
  • FDA regulations
  • EMA regulations
  • Master agreement negotiation
  • Budget forecasting
  • Pricing and profitability analysis
  • Variance analysis
  • Business development
  • P&L management
  • Strategic planning
  • Partnership development
  • Stakeholder influence
  • Team leadership
  • Operations management
  • Resource forecasting

Categories

  • Healthcare
  • Management & Leadership
  • Science & Research
  • Consulting
  • Sales

Keywords

  • clinical trials
  • CRO
  • contract research organization
  • clinical trials management system
  • business development
  • P&L
  • profit and loss
  • ICH-GCP
  • Health Canada
  • FDA
  • EMA
  • master agreements
  • budget management
  • pharmaceutical partnerships
  • life sciences
  • site management
  • strategy
  • operations leadership
  • biotechnology
  • stakeholder management

Seniority

Senior

Tools

  • Clinical trials management system

Languages

  • English

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