Executive Director, Head of Clinical Operations

7 hours ago

New York NY, United States Planet Pharma Full time

Job Summary:

The Executive Director, Head of Clinical Operations will report to the Vice President, Head of Operations and Program Management and will lead and oversee all aspects of Global Clinical Operations for client Development Programs. This responsibility includes supervising the successful planning and consistent execution of all client sponsored clinical trials within timelines, quality standards and budget. This individual is also accountable for adherence to relevant regulatory requirements and company SOPs. Finally, the Executive Director, Head of Clinical Operations will oversee implementation of all clinical trial activities utilizing both internal and external resources.Essential Duties and Responsibilities:

• Represent Development Operations on the Program Team (contribute to drug development strategy, planning, timing, cost projections) at the program level as well as the individual clinical study level
• Deliver data-driven, actionable operational and strategic insights for defining, planning and execution of a clinical development program and all associated studies (i.e. generation of operational timelines, enrollment models, assessment of availability of the patient population, complexity of trial designs etc.)
• Provides the operational perspective to the Clinical Development Plan and to trial protocol design, ensuring that leadership is aware of operational considerations and options
• Responsible for driving execution of high-quality clinical studies within established timelines and on-budget and for proactive issue management and resolution.
• Responsible for the development of the cross functional study/program costs for the Program Team, portfolio process, and financial updates
• Builds collaborative relationships with key internal and external stakeholders and influences all levels of management and cross-functional team members to develop strategies and execute plans to achieve program objectives.
• Responsible for executing clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and KPTI policies and all applicable procedures)
• Responsible for maintaining Clinical Operations business standards across studies (tracking, reporting, agendas/minutes, etc.)
• Responsible for the Clinical Program(s) always maintaining a state of inspection readiness, and act as an expert during regulatory inspections
• Responsible for operational decision making, risk mitigation, and contingency planning as well as operational efficiency and innovation at the program level
• Provide leadership for a global clinical operations team including oversight of development and training of team members
• Drives the development and maintenance of SOPs/Work Instructions, systems and processes for the Clinical Operations organization at client.
• Responsible for overseeing development and implementation of high-quality study plans, enrollment projections, site feasibility, risk identification and mitigation strategies.
• Responsible for providing oversight of the entire clinical operations budget for all development programs and ensuring it is managed within company thresholds.
• Performs other related duties as assigned by the direct manager.What you need to succeed (Requirements):

To succeed in the role, we believe that you have;
• BA/BS in life sciences, scientific or other related discipline or equivalent experience.
• 10+ years experience in a pharmaceutical, biotechnology, or CRO environment leading consistent global clinical trials execution.
• Experience leading Ph 1to Ph 3 and post-marketing clinical trials.
• In depth knowledge of GCP and ICH guidelines as well as understanding of regulations and guidelines (eg,. FDA, EMA) applicable to clinical development.
• Experience in directing, leading, motivating and developing team members within a global clinical environment.
• Demonstrated leadership skills and the ability to mentor and support development of staff members.
• Proven record of developing and maintaining relationships with external partners and CROs.
• Significant experience in contract negotiation, management and clinical operations budgeting.
• Sound judgment and reasoning skills to define problems, collect and analyze data, establish facts and recommend a course of action.
• Ability to work independently and collaboratively in a fast-paced team environment
• Able to travel domestically and internationally, as needed
• Applicable GxP experience/training relevant to function

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