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 investigatorsmotivating 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 manag