Senior Manager, Evidence Generation Lead

• 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
• 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
• 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
• 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
• 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

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

• Launch team experience
• Immunology/GI experience

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development