Global Study Start Up Lead

Summary

Join AbbVie as the Global Lead, Study Start Up and Maintenance, where you will be the primary point of contact for defining and executing global country and site activation plans for a specific therapeutic area. This role requires expertise in gene therapy study start-up and a strong understanding of the challenges involved. You will provide strategic input on study plans, establish global activation plans, drive alignment with various teams, and monitor progress against KPIs. The position demands proven leadership skills, strong analytical abilities, and a deep understanding of global clinical trial regulations. This US-based role offers remote work flexibility.

Requirements

• Bachelor's Degree required, degree in health care or scientific field preferred
• A minimum of 8 years of global study start up and clinical project management experience and thorough knowledge of global clinical trial regulations and processes
• Proven leadership skills in a cross-functional global team environment, experience in managing remote/virtual teams, and an ability to influence and align stakeholders, while modeling and driving AbbVie’s leadership attributes
• Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making. Excellent interpersonal skills with the ability to build trust and communicate persuasively and with clarity, flexibility and adaptability to changing requirements
• Demonstration of successful start up execution and aptitude for managing multiple priorities in a fast‐paced environment
• Advanced working knowledge of ICH and GCP guidelines and operational understanding of the global regulatory environment

Responsibilities

• Provide start up focused strategic input on the study plan, country strategy, start up timelines, site profiles and risk assessments for their assigned TA and/or Indication
• Establish global activation plans in partnership with SSUM Area Leads and SML, including risk assessments and mitigation planning
• Drive alignment with CTS and Regulatory on global submission strategy to assure coordination with EC submissions, contract execution and activation planning
• Drive standardization in global start up process and training, including sharing of best practices and lessons learned
• Monitor start up progress against established Start Up KPIs and Milestones
• Oversee SSUM Area Leads and Specialists from an operational perspective for their assigned trials
• Partner with CPD and SMM TA Leads to facilitate cross-functional communication and collaboration
• Support the development and maintenance of SOPs, tools, and templates for study start up activities
• Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines

Preferred Qualifications

• Expertise in gene therapy study start-up, including regulatory/ethics committee submissions and site activation plans
• Strong understanding of the specific challenges in launching gene therapy studies from protocol development through site activation

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs
• Remote work