Medical Director, Evidence Generation

Alfasigma; Utrecht; Hybrid; EUR 170,000 - 210,000; Full time

Job summary

Alfasigma seeks a Medical Director, Evidence Generation, to drive strategic and operational activities of Medical Affairs through real world evidence generation. You will design studies, lead IEGPs, and collaborate across Medical Affairs, Publications, Pharmacovigilance, and Clinical Development to demonstrate product value.

The role emphasizes cross-functional leadership, regulatory compliance, and stakeholder engagement across the EU in a hybrid setup.

Qualifications

• Advanced degree and solid years of experience in evidence generation, HEOR, or related field.
• Experience designing and overseeing real-world evidence studies from protocol to delivery.
• Strong cross-functional collaboration across Medical Affairs, Publications, Pharmacovigilance, and Clinical Development.

Responsibilities

• Lead development and execution of Medical evidence generation strategy aligning with corporate goals and regional needs.
• Oversee Integrated Evidence Generation Plans (IEGPs) with clinical, real-world, and economic data.
• Provide epidemiological and HOR insights to brand teams and safety, and disseminate through reports and peer-reviewed publications.
• Ensure budgets, timelines and resources for evidence projects with quality and compliance.
• Foster a ONE Team culture and develop a high-performing Medical Affairs team.

Skills

Epidemiology

HEOR

RWE consulting

Project management

Stakeholder collaboration

Education

MD/PhD/PharmD or MPH/Health Economics

Job description

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.

This role can be based anywhere in the European Union and offers a hybrid working setup.

Your role

Identify major end results or accountabilities for the position. These should reflect, when taken together, the main purpose of the position. Please list in order of importance, at least as far as the top 4 or 5 most obvious ones are concerned. Try to formulate them using an action verb to describe the role/impact of the job, the output area, any territorial "limits" or constraints, if applicable along with the reason for the "output". Use gender neutral language.

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
• Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team

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
• 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

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 you are

• Advanced degree in a relevant field (e.g., MD, PhD, PharmD, or master's in public health or health economics) and relevant and solid 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
• 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)
• Experience in Rheumatology, specifically Rheumatoid Arthritis, is a strong plus.
• Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
• Launch team experience and Immunology/GI experience strongly preferred