Key Skills

Job Description

As our Global Medical Manager (GMM) within Medical and Clinical Affairs, you work in close collaboration with corporate functions, including Clinical Development, Pharmacovigilance, Regulatory Affairs, Market Access, and Marketing and Sales functions. As a GMM you contribute to strategic medical planning for the assigned company products. Furthermore, you have the scientific, clinical, academic credentials and experience to be able to engage with thought leaders and represent a central source of medical science and conduit for communication with health care professionals. This role can be based either in Amsterdam or Brussels. Key accountabilities: 1. Medical expertise Develop and execute the multi-year global medical strategy for all Prothya products. Serve as the key medical-scientific expert and represent Prothya with scientific leaders, patient groups, and regulatory authorities. Develop the communication strategy and publication plan with the Global Communications Lead. Lead proactive and responsive scientific communications, ensuring all content is current, evidence-based, transparent, and consistent. Provide medical oversight for clinical development, ensuring high-quality, ethical, and regulatory-compliant data. Identify evidence gaps and develop strategies to generate relevant clinical and real-world data. Review and support investigator-initiated research, collaborative studies, medical studies, and educational grants. Support the design and execution of Phase I-IV studies, registries, epidemiological studies, and outcomes research. Provide medical leadership on benefit-risk assessments and evidence-based decision-making. Support scientific communications, publications, medical inquiries, and insight-generation activities such as advisory boards. Monitor medical and scientific trends and assess their impact on the business. Provide medical-scientific training to internal and external audiences. Define research questions, data sources, and methodologies to evaluate product safety, effectiveness, and patient value. 2. Interaction with internal and external stakeholders Review and approve public and promotional materials, ensuring scientific integrity and regulatory compliance. Represent Global Medical on cross-functional teams and contribute to regulatory dossiers, labelling, drug safety, and risk management. Partner with Legal, Compliance, and Regulatory to ensure ethical engagement with external stakeholders. Build strategic relationships with scientific leaders, KOLs, patient groups, centers of excellence, regulators, and reimbursement bodies. Provide scientific input to HTA discussions and clearly communicate product value and benefit-risk. Ensure patient communications are balanced, accurate, and understandable. Strengthen internal and external partnerships to support evidence generation and maximize patient value. 3. Research and development Identification and leveraging key scientific and technological advances, resulting in informed-decision making and development of innovative and competitive products to increase the success of product development. Guide strategic product development. Develop clinical trial design. Medical oversight over sponsored clinical trials following GCP. Review and assess proposals for external research. 4. Ethics and compliance Ambassador for scientific integrity of data produced, or communicated by Prothya. Acts in full compliance with current standards (legal, ethical, industry codices), and ensures adherence of internal as well as external collaborators. 5. Leadership Translates company objectives into annual Medical Affairs business and strategy objectives and makes sure the objectives are met. Manage the Medical Affairs department. Organizes the activities and tasks needed to function as a successful team. Coach and appraise employees, and develop employees using the relevant HR instruments, service and procedures. Ensures a safe, secure, and healthy work environment. Ensures collaboration within the team and other departments. Your profile Background and knowledge Academic work and thinking level. A medical degree (M.D.) is strongly preferred with a specialist certification in a specific disease area. >3 years of experience in a similar role within (global) medical affairs is required Experience in Immunology and hematology through clinical/R&D work-experience is a must. Experience in Rare disease space and hematology is preferred. Experience in field-based roles (e.g. Medical Director) is preferred. Experience in clinical development is preferred. Experience and understanding of International (European and US) and national regulations in the field of clinical research, blood, and blood products. Understanding of blood products and blood-borne infectious diseases. Independence Ability to maintain extensive knowledge of the relevant therapeutic areas, diseases, stakeholders, patient journeys and unmet needs, clinical practice, research and development, regulatory, market access environment, and the competitive landscape; applies this knowledge to develop differentiated patient solutions. Ability to anticipate on trends and interprets signals in the ecosystem of care and maintains a holistic perspective of medical affairs-related activities externally and within Prothya. Understands the value of technology for high quality, consistent and efficient data capture, processing, and analysis, including AI. The GMM work is carried out independently within the research question, quality requirements of Good Clinical Practice, applicable legislation, and national and European regulations. Personal skills Ability to collaboratively build, control, and continuously adapt the project plan, with the appropriate level of details, to achieve the project objectives. Gathering and interpretation of information: Uses quantitative and qualitative methods to obtain relevant information about stakeholders’ needs, motivations, and behaviors in order to contribute to the generation of insights. Manages the process and/or teams to produce a deep understanding of stakeholders’ and/or patients’ needs. Leading others: Communicates the vision and sense of purpose with enthusiasm, and ensures strategic priorities are understood and acted upon. Shows trust and provides learning opportunities to reports through delegation and opportunity for participation in new and stretching assignments. Ability to engage people. Perseverance, constructive negotiation. Fluency in English, command of Dutch is additional benefit. What we offer: Full-time employment (40h) starting with a 1 year contract with the intention to extend. Salary between €6.215,77 and €8.935,13 gross per month (based on full-time employment). 8.33% holiday allowance and a 13th month. 30 holiday days (based on fte). A personal training budget of €2,100 every three years to foster professional growth and development. Contribution to travel expenses from the first kilometer. Excellent accessibility by public transport and private parking available. A pension plan with Zorg & Welzijn, providing security for your future. We do not accept unsolicited applications from recruitment agencies. Prothya does not accept unsolicited assistance from agencies in relation to this vacancy. Any CVs submitted, in any form, by recruitment agencies to any Prothya employee without a valid written search assignment will be considered the property of Prothya, and no fee will be payable.

Core Responsibilities

Develop and lead global medical strategy for Prothya products, providing scientific oversight for clinical development, evidence generation, medical communications, and benefit-risk decisions. Build relationships with scientific and patient stakeholders, ensure ethical and regulatory compliance, and lead the Medical Affairs team and its objectives.

Requirements

A medical degree is strongly preferred, along with more than three years of experience in a similar global Medical Affairs role and clinical or R&D experience in immunology and hematology. Knowledge of clinical research regulations, blood products, and blood-borne infectious diseases is expected; rare disease, hematology, field-based, and clinical development experience are preferred, as is fluency in English.

Benefits

• Holiday Allowance
• 13th-Month Salary
• 30 Days Of Annual Leave
• Personal Training Budget
• Travel Expense Contribution
• Public Transport Accessibility
• Private Parking
• Pension Plan