Clinical Specialist

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.