Gulf & Levant Evidence Generation & Medical Operation Lead

The primary function of the Evidence Generation Lead within an affiliate is to lead the development and execution of evidence generation strategies that align with local regulatory clinical and market access requirements specific to Gulf Levant. This includes overseeing real-world evidence (RWE) studies observational research and the collection and dissemination of data that demonstrate the value safety and effectiveness of our products in the Gulf Levant healthcare landscape. The role involves close collaboration with medical regulatory and cross functional teamsoften engaging with local health authorities physician networks and stakeholders to ensure that evidence generation studies are executed according to the regulations and performed according to the timelines.

Reporting to the Affiliate Medical Affairs Head/Medical Director this position represents the affiliate expertise for post-marketing observational other non-interventional studies and publications. The position provides operational advice/guidance to the Affiliate Medical Affairs organization for multi-country or local projects.

Qualifications :

Core Responsibilities

• Oversee the development and continual optimization of evidence generation project plans for the affiliate aligning them to both business objectives and scientific priorities.
• Ensure qualification ongoing monitoring and regular auditing of all Evidence Generation service providers strictly adhering to AbbVie guidelines and local regulatory requirements.
• Lead the design and execution of a variety of evidence generation initiatives including non-interventional studies pharmacoeconomic research epidemiology and Real-World Evidence projects.
• Manage the identification and selection process for research sites and investigators prioritizing engagement with clinicians and institutions of high scientific merit in alignment with AbbVies corporate strategy.
• Collaborate closely with Medical Managers and the Medical Director to ensure evidence generation activities address scientifically validated gaps and remain strategically aligned with both global and local product strategies.
• Ensure strict compliance with all regulatory standards and internal SOPs both local and global across all evidence generation activities.
• Oversee comprehensive budget planning fiscal control and payment processes for evidence generation projects investigator-initiated studies research sites and service providers guaranteeing cost-effective and timely execution.
• Foster and lead external scientific partnerships with medical institutions societies and consortia for collaborative studies database analyses and other evidence generation approaches.
• Act as the primary liaison to 1R&D within the affiliate coordinating cross-functional efforts and sharing insights from local evidence generation activities.
• Provide expert technical support to 1R&D in the planning and execution of interventional clinical trials ensuring that operational scientific and regulatory requirements are fully met.
• Develop and implement a robust publication planning strategy ensuring timely dissemination of key evidence generation outcomes through high-impact journals scientific meetings and internal communications. Oversee tracking and fulfillment of publication milestones partner with clinical teams and medical writers and maintain alignment with local and global AbbVie publication policies to maximize the visibility and impact of affiliate-generated research.
• Ensure effective establishment and ongoing development of local Evidence Teams integrating evidence generation planning across the affiliate. Oversee regular gap assessments to identify and address unmet scientific and strategic needs fostering collaboration and alignment with both local and global objectives.

Finance and Budget

• Manage and track medical and financial budgets ensuring accurate and timely reconciliation with the finance team on a monthly basis

In-field Metrics and KPIs

• Monitor and report on medical team matrix achievement highlighting areas of success and opportunities for improvement
• Escalate issues and anticipate challenges proposing solutions and working closely with the medical team to implement corrective actions
• Follow up with the medical team to ensure achievement of KPIs on a monthly basis

EG KPIs: 

• Track and report on evidence generation studies including:
  • Feasibility
  • Site selection
  • Enrollment completion
  • Publication across GULF Levant
• Collaborate with cross-functional teams to drive evidence generation initiatives and ensure alignment with medical strategy
• Collaborate with MIR operational lead to align KPIs and achievements ensuring seamless integration and reporting to intercontinental and global stakeholders

External Footprints

• Identify opportunities for external footprint and relationships and establish partnerships in clinical research and evidence generation to enhance organizational capabilities and drive business growth
• Collaborate with MIR operational lead to leverage global partnerships and opportunities

People Leadership

• Manage and report on Evidence Generation Manager/Specialist providing guidance and coaching to ensure achievement of Evidence Generation matrix and KPIs
• Lead and develop a team of Evidence Generation Specialists driving performance and growth through effective management and mentorship
• Oversee the work of Evidence Generation specialist/Manager providing direction and support to ensure successful execution of evidence generation plans

Miscellaneous:

• Part of Affiliate Medical Leadership Team
• Lead the Evidence Generation team and Medical Operations in Gulf Levant
• Undergo and maintain training as required by Global Clinical Operations and other relevant company procedures to ensure adherence to ICH GCP AbbVie GPRD SOPs and IQS processes and procedures local SOPs applicable regulatory requirements and study specific needs.
• Collect information from the market regarding market condition changes registration regulations / guidelines etc. changes and forward them to the direct supervisor regularly.
• Provide operational guidance where needed.
• Contribute to achieve satisfactory study audits.
• Ensure appropriate local SOP are in place to cover research projects conduct in the affiliate.

Additional Information :

Qualifications

• Appropriate medical background or healthcare-related qualification or experience.
• Minimum of 7 years Clinical Research experience of which at least 5 years must be in clinical research monitoring including demonstrable experience in clinical study coordination audit and management.
• Minimum of 5 years of Pharmaceutical industry experience is a must
• People Leadership experience is a must
• Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Written and verbal fluency in English and Arabic.
• Acute observational skills analytical and conceptual capabilities.

Internal / External Contacts and Interactions:

• Use multiple technologies to maintain open and frequent communication with internal and external customers.
• Interacts with builds and maintains professional and collaborative relationships with:
• Affiliate medical personnel:  Head of Medical Affairs/Medical Director; Medical Managers/Advisers; Medical Science Liaison; Affiliate Safety Representative / drug safety personnel / Affiliate Research team
• Other affiliate personnel: regulatory affairs Market Access finance legal etc
• Area based Therapeutic Area medical affairs teams.
• Participating in research Investigators and study personnel; thought leaders/external experts.
• Hospitals other healthcare providers Ethics Committee and Local Regulatory Authorities.
• Third party vendor (e.g. CRO data management)

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time