The Director of Clinical Operations (DCO) is responsible for the successful planning, management, oversight, and execution of clinical trials in Clinical Operations. The span of activities is broad, covering clinical activities in study start-up, initiation through completion - and will include clinical project management and CRO oversight duties.

 

The DCO will be involved in the daily operations of clinical programs. S/he must have a comprehensive understanding of ICH/GCP requirements, principles, concepts, industry practices, and standards. Under the direction of the VP Clinical Affairs, s/he is responsible for successful execution of clinical trials according to regulatory guidelines including oversight of CRA and vendors involved. S/he must facilitate effective internal and external relationships. S/he is responsible for achievement of project goals and objectives on time and on budget.

 

Responsibilities:

 

Strategic Planning

Contribute to strategic planning to ensure optimized clinical development plans for assigned projects.

Analyze therapeutic program to construct appropriate resources and budget and analysis of vendor proposals.

Analyze therapeutic program to implement strategies and management tools (e.g., clinical trial management systems, electronic data capture) to facilitate and improve operational and financial management of therapeutic program.

Analyze and develop action plans to address issues with investigational sites, CROs, etc.

Provide direction in CRO and vendor selection and management.

Provide feasibility assessment for new clinical protocols.

Assurance of regulatory compliance of investigational sites with company SOPs, regulatory and ICH guidelines.

Identify, recruit and approve CRAs

 

 

 

 

 

 Project Execution and Management

Manage clinical studies and the process to identify and solve operational issues and drive delivery to plan through internal and external partners (e.g., alliance partners, CROs and vendors).

Responsible for project management and execution, including the development, initiation, conduct and maintenance of realistic, up to date and appropriate quality, project, and study plans (including timelines and budgets) in agreed systems.

Oversee clinical trial conduct and monitor work performed internally and externally to ensure delivery against contract, according to budget and in accordance with corporate timelines.

Provide training, direction and oversight to CRAs involved in specific projects.

Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory Affairs to ensure operational excellence.

Prepare, review, and manage clinical research budgets, timelines, and performance metrics.

Act as operational interface with external partners (e.g., alliance partners, CRO and vendors) for externally managed/outsourced activities.

Review and provide technical expertise for vendor/partner contracts.

Oversee preparation of study feasibility and specifications.

Identify, recruit, and approve clinical investigators.

Maintain frequent contact and work effectively with site investigators and coordinators.

Prioritize study monitoring needs and resources.

Resource allocation.

 

Qualifications and Strongly Preferred Skill Requirements: 

Minimum of bachelor’s degree.  Additional training is preferred.

6 or more years of related pharmaceutical or biopharmaceutical industry experience, with at least 3 of those years directly in clinical operations. Additional experience in academic setting is a plus.

 

Preferred Skills and Experience:

Strong communication skills, proven negotiation skills and team player.

Strong understanding of pharmaceutical development, clinical development, clinical research, study design, biostatistics, pharmacokinetics, and medical terminology.

Strong time and project management skills.

Strong critical and logical thinking with ability to analyze problems, identify alternative solutions and implement recommendations for resolution.

Understands and interprets data/information and its practical application.

Self-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environment.

Takes ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.

Proficient in pertinent software and tools.

Must be knowledgeable in industry trends for clinical operations.

Must not have any travel restrictions and be able to travel for business globally.

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