Do you dare to shake up the medical world and improve the lives of patients with chronic degenerative diseases? Allegro is a revolutionary start-up that designs and develops ground-breaking biomedical nanotechnology for the treatment of osteoarthritis. We wish to hire a: Clinical Specialist The Job We are seeking a hands-on scientist with a passion for life sciences to join our team as Clinical Specialist. As a Clinical Specialist, you work directly with the CSO and RM of the company. You will actively perform: - Clinical Strategy - Medical writing - Project management Responsibilities: · Lead the Clinical Developmentment Strategy: Design and refine clinical development plans in alignment with corporate objectives and regulatory pathways, with a focus on value generation and risk mitigation. · Write Study Protocols : Collaborate with scientific, regulatory, and commercial teams to design high-quality clinical studies that address unmet medical needs and support product positioning. · Medical and Scientific Writing: Draft and review essential clinical documents, including study protocols, investigator brochures, clinical study reports (CSRs), (e.g., CER/LRR/PSUR). · Cross-Functional Project Management: Lead clinical project planning and execution, ensuring alignment across departments (R&D, regulatory, medical, and commercial) and timely delivery of milestones. · Stakeholder and Vendor Coordination: Manage interactions with external partners such as CROs, KOLs, investigators, and consultants to ensure efficient and high-quality execution of clinical activities. · Risk and Quality Oversight: Proactively identify clinical and operational risks, implement mitigation strategies, and uphold quality standards across deliverables. · Clinical Budget and Resource Oversight: Support budgeting processes, ensuring efficient allocation and tracking of clinical resources in line with project timelines and scope. · Regulatory and Ethical Compliance: Ensure that all clinical activities are conducted in accordance with ICH-GCP, relevant regulations, and internal policies. · Site Engagement and Education: Act as the primary liaison for study centers and clinical investigators—motivating and supporting them through clear communication, site visits, and ongoing education to ensure smooth study initiation and conduct. Requirements: · Minimum of 10 years of experience in medical writing, clinical strategy and clinical trial management, preferably in the medical device industry and/or within the field of osteoarthritis. · In-depth knowledge of ISO 14155, including FDA and MDR guidelines, and experience with regulatory submissions and leading clinical audits. · Exceptional (medical) writing skills · Strong analytical and strategic insights, and the ability to understand how your strategic choices translate to other domains (operations, statistics, regulatory…) · Strong project management skills with the ability to effectively prioritize tasks and manage multiple projects simultaneously. · Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders. · Proven leadership abilities, including the ability to lead cross-functional teams and motivate team members to achieve project goals. · Detail-oriented with strong analytical and problem-solving skills, capable of identifying and resolving issues in a timely manner. · Proficiency in Microsoft Office Suite and experience with clinical trial management systems (CTMS) and electronic data capture (EDC) platforms. Your Profile You have a: · Master's degree in biomedical sciences, medicine, or another life sciences degree. · Additional training and certificates in clinical research, regulatory science, or business is a plus. · English CEFR C2 (Mastery level) · Proven track record in designing and executing clinical studies, preferably in an international setting. You have the following skills: · Deep understanding of clinical development processes, including GCP, ICH guidelines, and regulatory requirements (EMA/FDA). · Demonstrated experience in writing and reviewing core clinical documents: protocols, IBs, CSRs, and regulatory dossiers. · Strong grasp of medical and scientific literature and ability to translate complex data into strategic and operational plans. · Experience leading cross-functional clinical teams and managing external partners (CROs, consultants, investigators). · Skilled in project planning, timeline tracking, and budget oversight in a matrixed environment. · Ability to identify risks, solve problems, and adapt in a fast-moving, dynamic organization. · Excellent interpersonal skills with a proven ability to build and maintain productive relationships with clinical sites, investigators, and KOLs. · Experience training or educating site personnel and motivating them throughout the trial lifecycle is highly valued. · Strong written and verbal communication skills; capable of presenting clinical strategy and study progress to internal leadership, boards, and external stakeholders. · Comfortable working in small, agile teams with high accountability and autonomy. · Experience in musculoskeletal, inflammation, or neurology clinical trials is a plus. · Familiarity with biotech startup environments and willingness to wear multiple hats when needed. · Science-driven, business-focused: applying state-of-the-art innovation to achieve strategic goals within a business context. · Analytical Skills: Demonstrate strong analytical and problem-solving abilities, with the capacity to leverage data and insights to drive informed decisions. · Planning and organization: work in a very well-structured manner · Meticulous perfection meets operational performance: a unique ability to deliver the highest quality work in short timelines. · Communication and Relationship Building: Exhibit excellent communication skills, both verbal and written. · Strategic Thinking: Display a strategic mindset and the ability to envision long-term goals while effectively managing day-to-day operations. Stay updated on industry trends and best practices to drive innovation. Our offering As a company An impact- and purposeful environment, in a young start-up that can change the lives of many people suffering from osteoarthritis. A high-performance and eager culture, An easy and uncomplicated team, but very eager and high-performance. An opportunity to learn a lot, and grow together with the company, make a positive impact, and build tomorrow’s future. The job allows for an ambitious person to build a great career as a top executive. For you · A great remuneration package with a substantial salary. · Company car. · Extra-legal benefits (hospitalization insurance, meal vouchers, …) · Premium working tools. You are stationed in Liège with flexible home office. Contact Do you want to join the future? Contact us via e-mail: · Info@allegro.bio · Subject: Clinical Specialist