Vice President, Clinical Development Operations
Our client is a biotherapeutics company. They have asked us to assist them in a search for a Vice President, Clinical Development Operations.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides overall operational leadership to all clinical programs.
- Actively oversees organizational effectiveness and addresses challenges that are impeding predictable and reliable operational delivery.
- Drives continued transparency of study level progress and challenges through leading operational governance.
- Manages departmental and program performance through key metrics and robust mitigation strategies.
- Identifies opportunities to take advantage of new opportunities to drive innovative delivery.
- Continually assesses operating procedures and take action to drive on-going quality improvement.
- Strategically partners with key internal stakeholders to manage operational and departmental risks, as well as ensure study delivery objectives are achieved.
- Creates relevant roadmaps to achieve strategic visions and aspirations.
- Provides guidance to ensure strategic operational input into all Clinical Development Plans.
- Leads teams to develop strategies to efficiently deliver according to company objectives.
- Develops approaches to connect with healthcare for an optimized patient and provider experience.
- Partners with IT to develop digital transformation vision and business cases for long term roadmap.
- Develops and manages department budget as well as overall clinical trial delivery budgets.
- Leads the prioritization of work and resources across all clinical programs.
- Ensures all Clinical Programs are adequately resourced.
- Ensures all areas of accountability are compliant with ICH/GCP guidelines as well as other regulatory standards and requirements.
- Drives inspection readiness and overall quality of clinical studies.
- Develops culture that enables successful recruitment and retention of high-quality staff.
- Creates a culture of high performing teams able to work effectively in a matrixed environment.
- Creates and encourages a culture of experimentation, innovation, and applied learning.
- Ensures effective utilization and performance management of staff.
- Embeds patient focus in all ways of working.
- Manages strategic vendor relationships to ensure consistent delivery of contracted services through direct communication with key vendor’s executive management.
- A degree in a scientific/medical/pharmaceutical/business discipline is essential, preferably combined with relevant post-graduate qualifications. An MBA is highly desirable.
- A minimum of 15 years working in a Clinical Operations environment is required.
- Must have proven leadership and global Clinical Operations experience.
- A comprehensive understanding of clinical trial processes is required.
- Requires strong attention to detail.
- Must have experience directing others.
- Planning and co-ordination skills are required.
- Innovation skills are required.
- Must have diplomacy skills.
- Written and oral communication skills are required.
- Proficiency in appropriate software is required.
- Requires strong time management skills.
- Must have strategic development and analytical skills.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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