Associate Director, Clinical Trial Lead (all genders), Overijse
Client:
Location:
Job Category:
Other
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EU work permit required:
Yes
Job Reference:
635d8459603f
Job Views:
2
Posted:
27.04.2025
Expiry Date:
11.06.2025
Job Description:
Your role: Manages multiple studies, projects, and work streams with high complexity, risk, impact, and reach, typically Ph III and registrational/sourcing models. Demonstrates skills in successfully leading large-sized global project teams in a matrix organization and directs, influences, and motivates stakeholders from closely related areas and beyond, creating a positive working climate.
Leads the development of the clinical trial strategy while being accountable for successful project execution, delivery of clinical operational budget, timelines, and quality standards as agreed upon by Governance Committees.
As a core member of the Clinical Operations Team and leader of the Clinical Trial Team, aligns the clinical trial team with organizational goals, Clinical Operations Team, and/or Global Program Strategy Team.
Filters, prioritizes, analyzes, and validates complex and dynamic information from diverse external and internal sources to respond to operational and organizational challenges holistically to mitigate risks.
Exhibits Subject Matter Expert level understanding of multiple functions and processes. Is familiar with and considers overall company strategy.
Acts as a senior advisor and mentor within the team and beyond, serving as a best practice resource within own discipline or as part of technical functional teams or projects.
Ensures all study management activities are completed in accordance with SOPs/WI, local regulatory guidance including ICH-GCP; leads audits, interviews, and responses.
Contributes to non-study-related initiatives in addition to study assignments. Provides reports to senior management, including updates and timelines, independently.
Demonstrates creativity and innovation to support projects from a strategic perspective, predicting outcomes and achieving goals.
Who you are:
At least 10-12 years in clinical research within a CRO or Pharmaceutical/Biotechnology industry, with at least 7 years of in-depth experience in clinical trial management including managerial responsibilities. An advanced degree (MPH, MS, MA, MBA, PharmD) and PM cPMP are desirable.
Proven experience in all aspects of clinical study planning and startup, including budget and resource planning, and executing study activities from startup through final report.
Experience in multiple therapeutic areas (oncology and immunology preferred).
Requires substantial professional experience in relevant disciplines and project management, with strong leadership and influencing skills.
Proven ability to foster partnerships across projects and multidisciplinary teams. Growing expertise in drug development, including knowledge of interfaces and interdependencies with other development areas.
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