Richard Nkulikiyinka
Clinical Development Consultant @ Logan Bioinformatics
About
- Senior leader in pharmaceutical development, board-certified in internal medicine, and epidemiologist. Wide-ranging industry experience in Clinical Development, Pharmacovigilance and Medical Affairs, spanning several Therapeutic Areas (Oncology, Anti-infectives, Dermatology, Cardiology & Nephrology) and all phases of development. Contributions to several successful regulatory approvals in all ICH regions. - Broad-based medical professional foundation thanks to diversified practice experience with a focus on acute care, including Accident & Emergency, Cardiology and Intensive Care. - Proven ability to swiftly establish teams and external partnerships that deliver results across a variety of environments and working models. Agile and motivational leadership style anchored on a multilingual background as well as on experience with living and working on several continents. - Strong analytical skills and organizational acumen; proven track record of successfully leading teams and large organizations through complex restructuring exercises as well as strategy evaluation and implementation initiatives. - Passionate about social justice, with a personal interest in the empowerment of socially and economically disadvantaged groups through evidence-based initiatives to improve healthcare, public health and education.
Germany
Berlin Metropolitan Area
Pharmaceuticals
Kardiovaskuläre Medizin, Leadership, Business Development, Product Launch, Cross-functional Team Leadership, Business Strategy, Strategic Consulting, Interdisciplinary Collaboration, Scientific Communications, Strategic Planning, Organizational Leadership, Leading transformational change, Clinical Development, Pharmaceutical Industry, Oncology, Cardiology, Drug Development, Clinical Trials, Pharmacovigilance, Life Sciences
Experience

Vice President, Head of Therapeutic Area Cardiology & Nephrology
Wuppertal Area, Germany
- Responsible for portfolio steering and strategic input for up to 15 pipeline programs, from the start of preclinical development until regulatory approval, in addition to oversight responsibility for the planning and execution of Phase II - III clinical trials. - Successfully shepherded two NME development programs to deliver very high quality results within very competitive timelines, leading to approvals in Chronic Heart Failure and Chronic Kidney Disease in all major ICH regions in the midst of the Covid-19 pandemic. - Built and expanded a high-performing team of clinical trialists and project leaders across locations in the US and EU, developing several talents into more senior positions within and outside the department. - Established a highly dynamic culture of knowledge sharing and synergistic collaboration across team and functional boundaries, highly prized by internal stakeholders and external collaborators. - Successfully fostered transformation in clinical trial design and conduct, driving strategic partnerships with selected academic institutions, as well as the development and implementation of a digitalisation strategy.

Head of Global Clinical Development Dermatology & Anti-infectives
Berlin und Umgebung, Deutschland
- Group Head responsible for all clinical strategy aspects of global Phase II – III development programs including studies conducted in the EU, US and Asia-Pacific, leading a team across locations in Germany and China. - Oversight of clinical programs in inflammatory dermatoses (rosacea, eczema, atopic dermatitis, psoriasis), acute bacterial infections (ABSSSI, complicated intra-abdominal infections, HAP/VAP) and parasitic disease. - Responsibility for 2 pediatric programs: systemic antibacterial (successful completion of phase 3) and topical anti-inflammatory agent (phase 3 design and set-up). - Co-Lead of company-wide R&D strategy implementation initiative, spanning all areas of research and development, and addressing capabilities, technologies, working models and new indication areas.

Head of Dermatology, Global Clinical Development, Intendis GmbH and Bayer Healthcare Pharmaceuticals
Berlin und Umgebung, Deutschland
- Department Head responsible for Clinical Strategy, Operations, Statistics & Data Management, and Safety & Medical Affairs for the Dermatology development portfolio in all phases of Development. - Oversight of clinical programs in inflammatory dermatoses (rosacea, eczema, atopic dermatitis, psoriasis) and esthetic dermatology. Successful conduct of a Phase 3 program for a new treatment option in rosacea, leading to NDA approval by the USFDA. Set up of development program for NME with novel MoA in psoriasis. - Department and team re-organization as part of the integration of the Intendis GmbH into Bayer Pharmaceuticals.

Risk Management Workshop Facilitator & Deputy Head of Risk Management Planning and Coordination
Berlin und Umgebung, Deutschland
- Safety risk assessment workshop facilitation (using the Problem-Based Learning model) for projects in all phases of development and across all therapeutic areas (Cardiovascular, Oncology, Women’s Health, Primary Care and Dermatology). - Contribution to the set-up of a new safety risk management framework, including introduction of Development Risk Management Plans and structured safety risk assessment workshops. Selection and training of new workshop facilitators and lead for continuous improvement activities within the risk assessment and evaluation framework.

Global Safety Leader, Oncology
Berlin
- Responsible for drug safety and risk management aspects of oncology products in development. - Lead of multi-disciplinary safety management team for a key oncology asset through global Phase II-III development and successful approval in 2 indications by the USFDA, EMA and PMDA; including preparation of FDA AdCom as lead presenter for safety.

Clinical Fellow, Intensive Care Medicine - Northwick Park Hospital
London, Großbritannien
- Multi-disciplinary 15-bed ICU with surgical, trauma, ID and internal medicine case mix. Responsible for day-to-day care including all bed-side procedures and interventions for organ support. - Review of serious cases by referral from other hospital departments and provision of advice to managing medical teams; Resuscitation UK-certified Advanced Life Support (ALS) instructor with hospital-wide resuscitation team lead duty on rotational basis. - Successful completion of residency program and internal medicine board examinations; qualification for Membership of the Royal College of Physicians (MRCP UK)

Senior House Officer, Internal Medicine - Northwick Park Hospital
London, Großbritannien
- Rotational residency in Gastro-enterology, Geriatrics, Stroke Medicine & Rehabilitation, and General Internal Medicine (including Acute Medical Admissions Unit). - Support of clinical research activities; and initiation and conduct of an audit program to evaluate and improve the quality of care of patients admitted with acute exacerbations of ulcerative colitis.

Senior House Officer, Accident & Emergency and Cardiology - Whipps Cross & London Chest Hospitals
London, Großbritannien
- Rotational residency in: • Accident & Emergency (department with 100K+ cases/ year; with full range of surgical, medical and trauma emergencies). • Cardiology (tertiary referral center with specialization in ischemic heart disease including emergency primary PCI for acute MI and routine PCI, and management of chronic heart failure). - Support for clinical research activities through in-hospital management of patients participating in stem-cell treatment studies for CHF. Initiation and conduct of audit program to evaluate and improve quality of cardiac resuscitation management in the A&E. - Royal College of Surgeons-certified Advanced Trauma Life Support (ATLS) Provider.

House Officer, Internal Medicine, Surgery and General Practice
Cambridge, Großbritannien
- Training rotation in General Surgery, Orthopedics and Trauma; General Internal Medicine and Gastroenterology; and General Practice. - Initiation and conduct of an audit program to evaluate and improve on guideline-compliant management of arterial hypertension in a GP practice. - Resuscitation UK-certified Advanced Life Support (ALS) provider.
Education

Medicine
Pre-clinical and Clinical Medicine studies. - Cambridge University Overseas Trust scholar. - William Harvey scholar (Cambridge University School of Medicine). - Dissertation on HIV Prevention in Sub-Saharan Africa. - Medical Elective in the pediatrics department of the Rwanda National University Hospital, in Kigali.
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