Global Medical Director – Evidence Generation – Innovation and Partnerships

Global Medical Director – Evidence Generation – Innovation and Partnerships

Requirements

• MD or PhD in Epidemiology/Public Health, or equivalent advanced degree in the relevant field, OR Minimum of 10 years of experience in clinical research, RWE/Epidemiology, medical affairs, clearly demonstrating expertise in developing RWE/epidemiological studies, as well as study management and publications.
• Prior experience in clinical trials, RWE/Epidemiological studies including understanding of trial methodology, design, management, and execution.
• Demonstrated experience in leading global evidence generation initiatives as well as study management and publications.
• Professional fluency in English.

Responsibilities

• Provide strategic and operational input into clinical development plans and the development of integrated patient journey to ensure robust evidence generation.
• Accountable for designing and overseeing the execution of phase 3b, phase IV clinical trials, observational studies, claims database analyses and real-world evidence (RWE) studies.
• Develop and implement analysis plans to investigate the natural progression of the disease, including characterization of disease endotypes/phenotypes or patient diagnostic/care pathways and real-world treatment outcomes using observational study (i.e. registry) data.
• Collaborate with the scientific communication team to prepare conference abstracts and manuscripts for publication in peer-reviewed scientific journals to publish the results and scientific insights arising from observational studies.
• Lead the development of analyses based on data available from various registries and observational studies to support identifying and defining the right target population for any asset and/or the clinical trials recruitment strategy.
• Collaborate with R&D teams (e.g., clinical development) to provide analyses to support clinical trials (e.g., historical cohorts, outcome trends in specific patient populations) and Global project/brand teams to support launches.
• Ensure quality and timely preparation of deliverables through efficient collaboration with internal team and external vendors.
• Manage SBO Medical Services hub or vendor support to complete epidemiology/biostatistics deliverables (including statistical analysis plans, table shells, and programming specifications for implementation by internal statistical programming team and/or contractors).
• Prepare oral and written presentations and reports to effectively communicate results to internal and external stakeholders.

Preferred Qualifications

• Extensive experience in research including clinical studies, RWEs and claims database analyses.
• In-depth knowledge of clinical trial design, biostatistics, and data analysis.
• Proficient in regulatory requirements and guidelines for clinical research and evidence generation.
• Understanding of digital epidemiology platforms to conduct, analyze and disseminate epidemiological research.
• Utilizing digital databases/databanks to conduct epidemiological and RWE studies.
• Proven leadership and management skills in overseeing cross-functional teams in a global context.
• Excellent project management capabilities with the ability to prioritize and manage multiple projects concurrently.
• Outstanding written and verbal communication skills.
• Strong interpersonal abilities, enabling the establishment and maintenance of relationships with both internal and external stakeholders.
• Exceptional analytical skills for interpreting complex data and generating actionable insights.
• Effective problem-solving skills with a proactive approach to identifying and addressing challenges.
• High ethical standards and a commitment to maintaining scientific research integrity.
• Strong attention to detail with a commitment to quality.