Medical Director, Global Evidence Generation Lead

Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.

But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.

As we continue to grow, we are seeking a Medical Director, Global Evidence Generation Lead.

Scope of the role:

The medical Director, evidence generation is responsible for supporting strategic and operational activities of Medical Affairs Department at Alfasigma through real world evidence (RWE) generation. An integral part of Medical Affairs Research is the conceptualization and execution of scientifically credible research on Alfasigma products and their disease states / therapeutic areas. The development of a strategic real world evidence generation plan involves internal and external stakeholders to identify the most important research questions that will beneficially impact patient care. Successfully answering these questions will require the design of research that is fit for purpose (including pharmacoepidemiology research, registries, Health Outcomes Research (HOR), oversight of investigator-initiated research plan; etc.) with partnerships from other parts of Medical Affairs, Publications and Scientific Communications, Pharmacovigilance, Clinical Development, Market Access, and commercial functions.

 

Your Key Responsibilities:

Strategic Planning and oversight

• Collaborate with cross-functional colleagues to Lead the development and execution of Medical evidence generation strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources ensuring alignment with corporate goals, regional needs, and therapeutic priorities.
• Oversee the Design and implementation of Integrated Evidence Generation Plans (IEGPs) that incorporate clinical, real-world, and economic data to support product positioning and value demonstration.

 

Development and execution of Evidence Plans

• Scope RWE studies (Regional/National/Academic/Patient/Vendor), selection of new or existing academic (can include: ISR/lIS/NIS)/non-governmental registries (retrospective/prospective), management across various phases from start up, maintenance to final deliverables
• Translate (early) trial efficacy to real-world comparative effectiveness as part of early and late phase study planning, identification of subpopulations, and for potential risk-sharing purposes
• Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits and/or risks potentially associated with Alfasigma products
• Project management oversight – ensuring effective design, initiation and implementation of real world evidence studies, while ensuring effective study protocols and plans, managing budget and milestone tracking, and where appropriate contracting with partner organizations
• keep abreast on new data and developments in the field, key publications of interest, research methodologies and regulatory standards across the EU and New Markets regions and proactively address HOR strategy changes in collaboration with global and regional teams in anticipation of any trends
• Review and provide relevant RWE/HOR inputs to statistical analysis plans and analysis outputs
• Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
• Establish metrics to evaluate the effectiveness and impact of evidence generation activities on corporate an