Global Head of Clinical Development Women's Healthcare Portfolio

Job description

Join the professional team of Gedeon Richter Plc., a leading pharmaceutical company in Hungary and the region! New molecules, new medicines, new processes, and new technologies - Richter invites innovative minds to exploit their full capacities. With our research and development base with 1000 professionals, we have one of the most significant innovation centres not only in Hungary but in the entire Central and Eastern European region. In addition to applied scientific work, we also support individual research fields and topics, as well as publishing activities and participation in scientific life. Gedeon Richter is looking for a committed and experienced professional for the position Global Head of Clinical Development Women's Healthcare Portfolio Responsibilities Clinical Strategy & Program Design (Primary Focus) Define and lead global clinical development strategies for WHC assets. Design end-to-end clinical programs, including indication sequencing, study design, endpoints, comparators, and evidence generation plans, maintaining close cooperation with Clinical Science, Clinical Operations, Regulatory Affairs, and Clinical Safety. Ensure clinical differentiation and competitive positioning through innovative and fit-for-purpose study designs. Drive scientific rigor and medical relevance across all development programs. Lead data analysis and the development of conclusions for Clinical Study Reports (CSRs). Integrate real-world evidence, patient-centric endpoints, and innovative methodologies into development strategies. Portfolio & Asset Leadership Translate asset strategy into robust clinical development plans aligned with portfolio priorities. Provide critical clinical input into Business Development, licensing, and lifecycle management decisions. Participate in shaping Target Product Profiles (TPPs) and value propositions for WHC assets. Represent Clinical Development in governance and investment decision-making forums. Non-Operational Scope Clarification Accountable for defining what should be studied and why (clinical strategy and program design), and for ensuring aligned site-selection decisions in partnership with Clinical Operations. Regulatory & Medical Interface Partner with Regulatory Affairs to define optimal global registration strategies (FDA, EMA, and other health authorities). Contribute to regulatory interactions, scientific advice activities, and submission strategies. Ensure clinical programs meet regulatory expectations and evolving scientific standards. Cross-functional Collaboration Work closely with R&D (including Clinical Operations), Regulatory Affairs, Medical Affairs, PV & Safety, Market Access, and Commercial teams. Ensure alignment between clinical evidence generation and future market access and payer requirements. Collaborate with Translational and CMC teams to ensure integrated development strategies. External Scientific Leadership Engage with key opinion leaders (KOLs), investigators, and academic partners. Represent the organization at major scientific congresses, advisory boards, and scientific forums. Support external innovation initiatives, strategic partnerships, and in-licensing opportunities. Team Leadership Lead and develop a team of Clinical Leads, Clinical Scientists, and physicians focused on clinical strategy and program design. Foster a culture of scientific excellence, innovation, collaboration, and accountability. Ensure optimal portfolio-level resource prioritization and allocation. Requirements Key Qualifications & Experience MD required; PhD in Life Sciences is considered an advantage. 12-15+ years of experience in pharmaceutical clinical development. Strong track record in designing global clinical development programs and strategies that support product differentiation, preferably within Women's Health Care (WHC). Demonstrated success in achieving regulatory approvals and establishing differentiated clinical positioning. Experience in Women's Healthcare, including fertility, contraception, menopause, and gynecology, as well as oncology. Clear understanding of clinical development interfaces across R&D functions, including Clinical Operations (without direct operational responsibility). Experience working in global, matrix-based organizations. Other requirements Key Competencies Strategic and scientific leadership. Deep expertise in clinical trial design and clinical development pathways. Strong business acumen combined with a patient-centric mindset. Excellent influencing, communication, and senior stakeholder management skills. Ability to clearly distinguish and align strategic responsibilities with execution and operational accountabilities. Key Qualifications & Experience MD required; PhD in Life Sciences is considered an advantage. 12-15+ years of experience in pharmaceutical clinical development. Strong track record in designing global clinical development programs and strategies that support product differentiation, preferably within Women's Health Care (WHC). Demonstrated success in achieving regulatory approvals and establishing differentiated clinical positioning. Experience in Women's Healthcare, including fertility, contraception, menopause, and gynecology, as well as oncology. Clear understanding of clinical development interfaces across R&D functions, including Clinical Operations (without direct operational responsibility). Experience working in global, matrix-based organizations. Competencies Cooperation Result-orientation Professional skills Change management Self-development, developing others Leadership and success Reporting Line Reports to: Head of WH R&D Portfolio & Strategy. Direct reports: Clinical Leads and Clinical Scientists. Success Measures Quality, scientific rigor, and robustness of clinical development strategies and study designs. Successful achievement of regulatory approvals and differentiated product labels. Strength and relevance of clinical evidence supporting the asset value proposition. Effective cross-functional collaboration across R&D, including a well-defined and productive interface with Clinical Operations. What we offer Extensive benefits package (cafeteria, stock program, private life insurance) Home office opportunity (2 days /week) Flexible working hours Training and development opportunities In-house medical services and Medicover service Various sports opportunities (gym, swimming pool, AYCM) Challenging, responsible professional work Long-term employment Innovative and secure workplace The Richter community is looking forward to your application.