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 and product-specific objectives.

Cross-Functional Leadership and Collaboration

• Provide epidemiological, HOR, patient-reported outcomes, or/and RWE consulting and support to brand teams, program teams, and safety, and disseminate technical information through technical reports, presentation, and publication in peer-reviewed literature as agreed by the team
• Represents Alfasigma at medical meetings, conferences, advisory boards, outreach meetings at key institutions and in interactions with thought leaders, as relevant
• Collaborate with scientific communication and medical directors in development and communication of key literature analyses to internal stakeholders; provide strategic support of publication planning and participate on publication team to provide medical and scientific oversight to publication and scientific presentations
• Engage with key external stakeholders, including scientific advisory boards, research partners, and thought leaders, to ensure that evidence strategies are scientifically robust and aligned with market needs.

Operational Excellence

• Oversee budgets, timelines, and resources for evidence generation projects to ensure efficient execution and adherence to quality standards.
• Drive innovation in evidence generation methodologies, incorporating new technologies, advanced analytics, and digital health tools.
• Ensure compliance with ethical, legal, and regulatory standards in all evidence generation activities.

Team dynamics and Development

• Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients and customers as our top priorities
• Make Alfasigma a truly desired place to work

Who are you:

Work Experience

• Minimum of 7+ years of experience in evidence generation, clinical development, HEOR, or a related field, with at least 5 years of experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research 
• Proven track record of developing and implementing integrated evidence generation plans in the pharmaceutical or biotechnology industry.
• Experience in design, conduct and oversight of real-world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication.
• Solid understanding of the cross functional drug development lifecycle and processes (Business Development, clinical trial design, conduct, & endpoint selection, Clinical Operations, Data Management, Biostatistics, and Regulatory)
• Demonstrated expertise and experience working with methods for evidence generation using primary and secondary data sources, knowledge of common issues and challenges of implementation, and track-record of successful publications
• Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
• Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
• Ability to explain strengths and limitations of clinical practice datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing pharmacoepidemiology study designs
• Ability to work successfully in a matrix and quick paced environment
• Ability to multitask priorities to align with program objectives.

Launch team experience and Immunology/GI experience strongly preferred

Education

• Advanced degree in a relevant field (e.g., MD, PhD, PharmD, or master’s in public health or health economics).

Competencies & Major Skills

• Strategic thinker with the ability to translate corporate goals into actionable evidence plans.
• Strong knowledge of pharmacoepidemiologic methods
• Strong understanding of drug development and commercialization concepts
•  Strong inter-personal skills and problem-solving capabilities
• Ability to work independently in a proactive manner
• Able to create, track and plan timelines and budgets
•  Proficient in Microsoft Excel, PowerPoint, Word
• Strong verbal and written communications skills
• Learning agility and ‘scalability’ to take on increasing responsibility as Intercept grows
• Consistent demonstration and embodiment of company core values: passion for innovation, teams build the future, think big act small and learn to dare
•  Ability to have fun and thrive in a growing, diverse, and inclusive work environment

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success.
 We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.

Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.