Danielle Nommay

Danielle Nommay Mob: - - www.linkedin.com/in/danielle-nommay-07b8778 Address : 26 Cours A.Briand- 69300 Caluire – Rhône- France Location preference: France or remote, eager to travel Experienced Medical Affairs Leader in Pharma/Biotech, Spearheading Innovation and Patient-Centric Solutions across France & Europe Profile summary Dynamic and results-driven Medical Affairs Leader with over 15 years of experience across oncology, immunology, rare diseases, and nuclear medicine. Expertise in developing and executing medical strategies, driving market access, and leading product launches in both mature and emerging markets. Proven track record in leading cross-functional teams, building strategic relationships with Key Opinion Leaders (KOLs), and engaging with health authorities to successfully drive clinical research and medical initiatives. Skilled in Early Access Programs (EAPs), clinical trial design, and health economics and outcomes research (HEOR). Adept at translating scientific data into actionable business strategies, enhancing communication, and supporting regulatory processes. Known for fostering collaboration across functions to align business goals and improve patient care. Seeking a senior role to leverage my leadership and strategic expertise in a fast-paced, innovative environment. Key Skills Medical Strategy & Leadership Medical Strategy Development & Execution Cross-Functional Leadership & Team Development Project Management & Budget Planning Market Access & Product Launch Early Access Programs (EAPs) Regulatory Affairs & Compliance Clinical Development & Research Clinical Trials & Research Collaboration (Externally Sponsored Research - ESRs) Health Economics & Outcomes Research (HEOR) real world evidence (RWE) Scientific Communication & Medical Writing Clinical Trial Design & Feasibility Assessments Stakeholder Engagement & Relationship Building Key Opinion Leader (KOL) Engagement & Relationship Building Scientific Partnerships & Collaboration with External Experts Patient Advocacy & Engagement with Patient Associations Data & Communication Expertise Scientific Data Translation into Actionable Business Strategies Medical Communications & Congress Planning Publication Strategy & Real-World Data (RWD) Analysis Career Highlights Medical Affairs Leadership: Successfully established and led the medical affairs function in France and BeNeLux driving the pre-launch strategy of innovative drug. Developed and executed the cluster medical strategy, and scientific communication, enhancing cross-functional collaboration and ensuring alignment with global objectives. Product Launch & Market Access: Spearheaded the launch of innovative therapies across multiple therapeutic areas including oncology, rare diseases ( Neurology, nephrology), and infectious diseases, achieving successful market entry and patient access. Team Leadership & Development: Recruited, developed, and led high-performing teams of Medical Advisors, ensuring effective collaboration with internal and external stakeholders, increasing in team performance and successful product pre launches. Strategic Partnerships: Fostered strategic partnerships with KOLs, scientific societies, patient associations, and regulatory authorities, contributing to the successful execution of Early Access Programs (EAPs) and clinical research initiatives. Career History 2024-Present Syneos Health on behalf of Immunocore Cluster Medical Lead, France – BeNeLux Oncology, Immunology – Uveal Melanoma, Cutaneous Melanoma Established and led the medical affairs function in France and BeNeLux for Tebentafusp in uveal melanoma. Developed and executed the medical affairs strategy, aligning with global objectives for product launch. Led scientific and medical activities, including congress planning, HCP engagement, and medical communications. Drove the successful implementation of Early Access Programs (EAPs) and Externally Sponsored Research (ESRs), enhancing medical communications and patient enrollment. Recruited and managed a team of Field Medical Advisors, fostering strong relationships with KOLs, academic institutions, and government bodies. Strengthened cross-functional collaboration with commercial, market access, and compliance teams. Managed budget planning and resource allocation to ensure efficient use of resources. - Adacap (Advanced Accelerator Applications) – Novartis Medical Affairs Consultant Internal Vectorized Radiotherapy, Prostate Cancer Developed and facilitated early access to Pluvicto ([177Lu]Lu-PSMA-617), enrolling the largest global cohort of patients treated through EAPs. Collaborated with cross-functional teams to provide medical input to market access, contributing to the successful reimbursement dossier and obtaining ASMR III for Pluvicto. Developed and executed the national strategy for medical affairs, expanding medical education and communications initiatives.(congress abstracts ASCO, ESMO, AFU) Led a team of MSLs, ensuring excellence in medical communications and KPI tracking. Supported clinical trials by identifying investigators, conducting feasibility assessments, and preparing study documents. - Oncopeptides Country Medical Affairs Manager, France Onco-Hematology – Multiple Myeloma Established Oncopeptides' presence in France, leading market access operations and developing medical and business strategies from scratch. Played a central role in launching the Early Access Program (EAP) for multiple myeloma, treating the largest global cohort of patients. Built relationships with scientific societies, institutions, and regulatory authorities (HAS – ANSM). Conducted market surveillance to identify development opportunities and engaged stakeholders to improve product positioning. Managed regulatory compliance, project timelines, and communications for medical meetings (ad boards, workshops). Supported clinical studies and HEOR/RWE studies, developing scientific communications for a broad range of stakeholders. Cross-functional collaboration (HQ medical, clinical development, regulatory, market access, compliance, pharmacovigilance). - Advicenne European Medical Affairs Lead France & Europe Rare Diseases (Epilepsy, Nephrology) Led the medical affairs strategy for rare diseases, ensuring the integration of local market needs into global strategies. Successfully launched the first Early Access Program (EAP) for Sibnayal in distal renal tubular acidosis (dRTA), collaborating with patient associations and expert centers. Developed scientific partnerships with KOLs and organized strategic advisory boards to enhance product visibility. Managed scientific communication, congress events, and the development of real-world data publications. Played a key role in defining and monitoring the medico-commercial strategy for the commercialization phase in neurology Responsible for developing scientific partnerships with epilepsy experts and preparing the pre-launch of a rare disease product in nephrology. - Ultragenyx Country Medical Affairs Lead, France Rare & Ultra-Rare Genetic Diseases (GNE Myopathy, MPSVII) Led medical affairs activities across rare and ultra-rare genetic diseases, developing local strategies for product launches. Worked closely with KOLs and patient associations to ensure successful patient enrollment in clinical trials and early access programs- Pharmamar Country Medical Affairs Manager, France Oncology (Ovarian Cancer, Soft Tissue Sarcoma, Multiple Myeloma) Developed and executed national medical affairs strategies in oncology, supporting product launches and market access initiatives. 2012 Atlantic Healthcare European Consultant Medical Affairs Lead, France & Switzerland Rare Diseases (MICI) Led medical affairs initiatives across GI rare diseases, focusing on regulatory compliance, KOL engagement, and product communication- Start-up Project Manager Led project development, scientific partnerships, and funded research in infectious diseases- Gilead Sciences / Nexstar Regional Project Manager HIV, Hepatitis, Infectious Diseases, Onco-Hematology Managed regional projects across HIV, hepatitis, and oncology, developing strategic initiatives to enhance product positioning and clinical studies development Education Master in Business Administration – IAE Lyon Training PhD Neurosciences (DEA) – Aix Marseille II University GCP training- EFGCP( European Forum for Good Clinical Practice) Early Access Process Training – LFSS 2021 (IFIS) Languages French – Native English – Fluent Voluntary Roles Expert Contributor – White Paper on Medical Misinformation & Disinformation (Femmes de Santé) Jury Member – Selection Panel for Business School Students, ESDES Lyon Handicap International (HQ Lyon) – Led communication activities and coordinated volunteer teams. Habitat et Humanisme – Led communication team, overseeing media relations and private funding initiatives. Fondation Valentin Haüy – Contributed to the foundation’s initiatives supporting those with visual impairments.