Senior/Director, Clinical Operations
Senior/Director, Clinical Operations
Posted on :
23-06-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
23-06-2025
Job Description
Essential Duties And Responsibilities
- Accountable for the delivery of the assigned clinical programs budget timelines and resource management with focus on quality including making recommendations and decisions regarding operational strategies to support study and/or program objectives
- Develop and present the operational strategy and plans including supply chain to effectively execute on the Clinical Development Plan
- Partner and collaborate with cross-functional stakeholders such as the Project Team Leader Clinical Development Lead Regulatory Lead and other relevant stakeholders
- Lead and oversee execution of first-in-human through phase 4 trials depending on lifecycle of program in compliance with ICH/GCP local regulations and Kardigans SOPs
- Drive the selection oversight and management of CROs and other vendors
- Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
- Own the strategy and execution of creative approaches to achieve Kardigans corporate goals. This may include innovative solutions to digital patient-oriented data capture and storage the development and deployment of novel clinical research platforms and approaches and the pursuit of collaborations that will enhance progress of Kardigans research programs
- Review and provide clinical operations input into relevant clinical documents such as the protocol investigator brochure regulatory documents clinical study reports and other documents and plans as appropriate
- Lead and provide oversight to the trial-specific operations team including the CROs/vendor(s) to function effectively and cohesively
- Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.
- Along with other Clinical Development personnel represent Kardigans externally to Investigators site staff and Key Opinion Leaders
- Perform and document study level Sponsor Oversight of outsourced clinical activities
- Communicate study-status cost and issues to ensure timely decision-making by senior management
- Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
- Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
- Lead and/or participate in Development Operations workstreams related to departmental and operating model related initiatives
- Develop and foster strong collaborative relationships with key stakeholders both within and external to Kardigans including Prolaio
- Directly manage assigned Clinical Trial Leads with a focus on performance coaching and career development; provide mentorship to Site Operations Managers/Associates by providing clinical operations expertise and support identification and prioritization of study and program level work.
- Strive for continuous improvement and more efficient ways of working in clinical development
Qualifications And Preferred Skills
- Minimum of BA/BS with at least 10 years of global clinical trial and clinical program experience including 6 years of high complexity independent global trial management experience. Advanced degree preferred.
- Experience within the field of cardiovascular or rare disease studies is preferred.
- Robust experience in early and late phase drug development; some late-stage development experience is required.
- Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation subject enrollment monitoring oversight protocol deviation management data cleaning etc.
- Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory CMC Biostatistics Data Management Finance Program Management etc.
- Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
- Experience in ICH/GCP inspections audits and inspection preparedness
- Outstanding communication skills both verbal and written
- Excellent organizational skills and ability to work independently
- Confidence to challenging status-quo thinking and behavior; can work with agility and an innovative mindset.
Employment Type
Full Time
Key Skills
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