Director/Senior Director, Site Activation and Regulatory Therapeutic Lead

Location: North Carolina, United States

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Requisition Number: 784

Position Title: Senior Director, Site Activation and Regulatory Therapeutic Lead

External Description:

The Director/Senior Director, Site Activation & Therapeutic Lead provides senior-level leadership and direction for all strategy development, operational planning, and delivery of global site contracting and regulatory affairs operations.  Ensure that deliverables are done with high quality and consistent with sponsor contractual agreements.  Standardizes and harmonize divisional processes to ensure consistency and improved efficiency.  Responsible and accountable for the effective management of the operational, financial, and staff development activities of the Site Contracts and Regulatory Affairs divisions within the Site Activation department.

RESPONSIBILITIES:

Tasks may include but are not limited to:

  • Implement the short-term and long-term objectives, major plans and programs of the global Site Activation and Regulatory Affairs division through integrated strategies with functional service customers
  • Ensure alignment of divisional goals to enhance the achievement of corporate strategy and overall department objectives
  • Drive authorized plans and initiatives for the division ensuring they are properly implemented, and that Executive Leadership are informed of the overall trends and conditions of all important activities that impact profitability, market position or stature in the industry
  • Line management responsibilities for division leaders in Site Contracts and Regulatory Affairs. Responsible for interviewing and selection, team building, terminations, professional development, performance appraisals, job description preparation, and employee counseling.  
  • Provide senior-level oversight for all deliverables for assigned projects, including implementation, quality, timelines, resource management, budget, and internal/external customer communications. Ensures all projects are managed and delivered in accordance with contractual agreements, agreed to Standard Operating Procedures, and in compliance with all industry/regulatory guidelines.
  • Develop and authorize specific performance standards to ensure key results in utilization, staff development, operating efficiency, innovation, physical and financial resources, public responsibility, and profitability for the Site Activation department.
  • Develop, review and maintain SOPs and best practice guidelines pertaining to activities of the Site Activation department. Identifies and makes recommendations of required technological and process improvements to increase quality and efficiency.
  • Review and input to budgets, assist with proposals and provide department representation at business development meetings

OTHER SKILLS AND ABILITIES:

  • Strong leadership skills
  • Excellent planning, strategizing, managing, monitoring, scheduling, and critiquing skills
  • Excellent written and verbal communication skills to clearly and concisely present information
  • Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment

REQUIREMENTS:

  • Bachelor's Degree or equivalent education and experience. 
  • At least 10 years experience within the function in CRO, pharmaceutical or other relevant area
  • At least 12 years management experience.
  • Proficiency in English
  • Proficiency with MS Word, Excel and Outlook

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City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Director/Senior Director, Site Activation and Regulatory Therapeutic Lead

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Morrisville, North Carolina US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

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