Position: Director, Clinical Affairs

5 mesi fa

Roma, Italia Meditrial Europe Ltd. A tempo pieno

Meditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs and market access. Our offices are located in Germany, Italy, Switzerland, UK, United States and our teams rely on digital tools to work collaboratively to achieve shared goals.

Since 2008, Meditrial delivers unparalleled outcomes for innovators. Our successful track record supporting the lifescience industry manufacturers in all phases of clinical development puts us in a prime position to seize the opportunity to emerge as a leader in digital technology with the promise that it will enhance and alleviate the clinical trial and participant burden. Through our work, the patient and innovator are empowered with data and insights across the lifecycle of product development and market penetration changing the paradigm of care towards understanding and value. We have the ability to transcend the current landscape with “smart” technology enabled data collection tools and insights.

Meditrial offers highest level expertise across multiple therapeutic areas. We are passionate about our mission to support the innovation and development of better therapies in compliance with solid ethical standards. Our commitment has resulted in excellent results for business growth by creating stability and opportunities for employees and collaborators.

**Position: Director, Clinical Affairs**:
**Industry**: Lifescience Industry: Pharma, Medtech, Digital Health

**Employment Type**: Full-time

**Job Functions**: Clinical Affairs

**Location**: Meditrial, Via Po 9 Rome, Italy

**Workplace**: Office-based / availability to travel

Meditrial is looking for a highly motivated, self-directed individual who will thrive in a fast-moving environment and possess strong interpersonal skills. The role is responsible for leading and managing the strategy, planning, and execution of clinical research and investigational affairs while assuring full compliance with applicable GCP regulations as well as relevant worldwide standards and regulations. Provides global leadership for Clinical Research Activities. Capable of interfacing with data management, biostatistics, regulatory agents, clinical research associates, study coordinators, field clinical specialists, business stakeholders, medical/safety monitors, and functional management. This role requires strong technical and client management skills, the ability to work with cross-functional teams: Sales, R&D, Management, Regulatory Affairs, and Marketing. The position is meant to work in Meditrial’s Rome Office, acting as strategic mentor to local team, fostering talents and effectively delegating.

**Responsibilities**:

- Develop global clinical affairs strategies, in collaboration with regulatory affairs, marketing, research & development, reimbursement, and outcomes planning, and obtain fast-track approvals
- Develop and execute Clinical Strategies to generate data for both marketing and regulatory purposes
- Engage and manage KOL / physician-clinicians and lead the management of all Clinical Affairs and required support
- Support regulatory/clinical strategies as clinical affairs leader
- Prepare clinical affairs budgets
- Develop and manage the Clinical Affairs Team: assign, direct, and evaluate their work, and oversee the development and maintenance of staff competence
- Develop clinical study strategy and protocols for investigational devices and/or for new products (Medical Device/Drug) being introduced to the marketplace
- Oversee the management, planning, and execution of respective clinical studies
- Provide oversight of individual clinical trials
- Serve as an interface to site coordinators, investigators and other field personnel regarding study devices and clinical protocols.
- Develop training and other clinical study support materials for investigational or study devices and procedures
- Interface with relevant internal and external stakeholders to ensure that clinical studies meet targeted enrollment and approval timelines
- Oversee the execution of clinical studies in compliance with FDA, local CAs, IRB and ECs and other applicable regulations and requirements, ICH guidelines, ISO standards, GCP requirements and in alignment with internal procedures, business goals and objectives
- Support and contribute to staffing plans according to needs

Skillset & Qualifications
- 8-12 years’ experience in clinical/scientific medical devices/pharmaceutical clinical trials and research.
- 5 years’ experience managing projects and working with clinical professionals and cross-functional product development teams
- Well versed in EU and FDA regulations and standards and GCP, ICH guidelines
- Familiar with the laws, regulations, standards, and guidance governing the conduct of clinical studies
- Excellent leadership, management, collaboration, and effective decision-making skills
- Education: Bachelor’s degree in Lifescience, Master in a hea

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