Medical Affairs Director Brazil & Head of Medical Affairs LATAM

MAIN RESPONSIBILITIES

Define and implement the local Medical Affairs strategy

• Lead the development and implementation of strategic and operational plans in the country, aligned with Ipsen Group’s mission, strategy, and values, in order to achieve global and local objectives
• Ensure the successful execution of the medical strategy in collaboration with responsible cross-functional teams
• Overall responsibility for resource allocation and budget control within the medical department, including corrective actions as needed
• Conduct proper medical due diligence, ensuring that Ipsen products maintain a positive benefit-risk profile, with an unwavering commitment to patient safety
• Ensure appropriate lifecycle management for all new and existing products
• Represent the country internally within the global medical organization

Manage day-to-day Medical Affairs activities:

• Coordinate and oversee the medical strategy, aligned with product strategies, in partnership with cross-functional teams
• When appropriate, provide promotional scientific information, clinical study insights, and training for sales representatives, ensuring compliance with internal SOPs, GCP, and applicable regulations
• Implement and manage patient support and diagnostic support programs in line with internal and external guidelines
• Ensure that all reasonable and necessary medical activities are planned and executed to generate value for patients and customers, while supporting and building commercial success within the relevant indications
• Maintain up-to-date clinical knowledge and expertise
• Medical activities include, but are not limited to, medical information, medical education, data generation, publications, medical representation, patient safety, and KOL management

  Responsible for Pharmacovigilance

• Act as the Qualified Person responsible for pharmacovigilance before local regulatory authorities
• Manage drug safety activities within the country
• Ensure that all products are overseen by qualified specialists and that cross-functional teams receive appropriate medical information
• Ensure compliance with local pharmacovigilance regulations and alignment with global procedures

Lead the Medical Excellence function

• Manage activities related to best execution practices and ensure alignment of local SOPs with local regulations and Ipsen internal policies
• Manage Medical Information and Customer Service (SAC) activities, ensuring proper oversight of service providers and compliance with local regulations and internal standards
• Coordinate the effective execution of field medical teams in alignment with their managers, including appropriate training

Oversee local clinical operations and execution:

• Identify and implement post-approval and unregistered Sponsored Clinical Studies, as well as Investigator-Initiated Studies, aligned with global medical strategy and asset data generation plans
• Ensure timely, compliant, and high-quality execution of all types of studies (including Ipsen-sponsored, national, international, interventional, non-interventional, prospective, retrospective, PASS, PAES, ISS), within agreed and available budgets, in consultation with the relevant teams and in line with the prescribed corporate strategy
• Develop strategies, where appropriate, to leverage Real-World Data (RWD) and generate relevant Real-World Evidence (RWE) to support local and global objectives, including but not limited to potential label extensions and market access
• Take appropriate action in case of deviations

Represent Ipsen with external partners and authorities:

• Represent the country medical team and Ipsen’s medical position to external opinion leaders, medical organizations, patient organizations, and regulatory authorities
• Collaborate with colleagues from other departments to build proactive and effective cross-functional communication, as well as to foster potential external partnerships
• Serve as the medical-scientific point of contact for Key Thought Leaders (KTLs)
• Represent Ipsen locally with partner companies

Oversee regional medical activities

• Represent LATAM in IMALT and within the global medical organization
• Represent the medical function in the regional leadership team
• Coordinate integrated actions across countries in the region
• Support the development of regional talent and promote potential exchanges across LATAM countries
• Identify opportunities to optimize resources and foster development across LATAM countries
• Oversee and support the implementation of “medical transformation” and “medical evolution” initiatives across the region.

EXPERIENCE, KNOWLEDGE, CAPABILITIES

Education / Certifications:

• Degree in Medicine or another higher qualification in Health Sciences
• A Master’s degree in Pharmaceutical Industry / Clinical Trials would be an advantage

Experience:

• Minimum of 8 years of experience in the Pharmaceutical Industry or biotechnology companies in High Specialty Therapy Areas
• Must have significant experience in Medical Affairs, including the design and oversight of Phase IV clinical studies
• At least 5 years of management or leadership experience
• Comprehensive understanding of the Pharmaceutical Industry and clinical operations

Languages:

• Fluency in Portuguese and English

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