Director, Clinical Operations
Hays

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Director, Clinical Operations in Waltham, MA.

Roles & Responsibilities

• The Director, Clinical Operations will ensure that clinical stage programs achieve program objectives within established timelines, budget, and quality standards.
• Contributes to the development of clinical program strategy and executes on that strategy
• Accountable for results of clinical trials under their program
• Provide leadership and direct line management to clinical operations team
• Emphasis will be on superior execution, transparency within the department and to Senior Management, and ability to employ cost effective measures and stewardship relative to clinical trial cost projections and final accounting for company
• Lead and direct the clinical operations team responsible for management and execution of all clinical trials
• Provide strategic and technical guidance to ensure that clinical trials are properly defined, planned, and executed
• Assist in the authoring of key regulatory documents (e.g., CTD, pre-meeting materials and briefing packages), study protocols, investigator's brochures, annual IND progress reports, study postings, and CSR for consistency across programs
• Develop in-depth knowledge of the clinical data and assures appropriate transfer of that knowledge to cross-functional study teams to achieve operational excellence
• Ensure that study objectives are in line with the clinical development strategy and the overall corporate goals
• Ensure external vendors are selected and managed to deliver within established timelines and budget
• Support the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines
• Foster a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders
• Demonstrates excitement around the Vison and Mission of company and the department
• Other duties as assigned

Skills & Requirements

• Bachelor's degree in health science or related field
• Minimum of 10 years in clinical trial management
• Excellent communication (oral and written), organizational, and problem-solving skills
• Strong attention to detail
• Expertise in clinical development process (Phase 1-3), global regulatory requirement, ICH guidelines, CGP and guidelines for clinical trials
• Extensive CRO/vendor management experience
• Excellent leadership, interpersonal, communication, planning and organizational skills

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

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Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information. #1144574