Head of Clinical Trials

Nuritas™ is a Dublin-based biotech company revolutionizing the discovery of novel and natural active ingredients with scientifically proven health benefits. Our disruptive approach to discovery provides access to the most health-benefiting components within foods by combining artificial intelligence and DNA analysis to data-mine billions of molecules.

Responsibilities

• Provide the depth of scientific expertise required for the clinical design and development of peptides.
• Design and implement preclinical and toxicology studies
• Design and implement of trials
• Oversee clinical operations in accordance with ICH-GCP guidelines including clinical trial management (Phase I), CRO selection, monitoring, third party vendor management and filing of all essential trial specific documentation.
• Analyse and professionally communicate preclinical and clinical results to inform development strategies.
• Manage multiple clinical projects to GCP standards.
• Provide oversight of all the responsibilities transferred from Client to CROs and other vendors.
• Manage and monitor/audit CROs
• Liaise with Commercial and other areas of the company integrating, defining and weaving clinical requirements into overall company strategy and vice versa.

Qualifications & Experience

• Relevant Science degree
• Candidate must be self-motivated, hands-on and willing to travel
• Must have demonstrable experience in designing and implementing trials
• A minimum of 10 years of experience in managing/co-managing multi-centre  clinical trials
• Significant experience working with and managing CROs
• Monitoring and project management experience
• Ability to audit and clinical trial sites
• GCP experience in the pharmaceutical industry
• A flair for scientific writing (protocols and reports) and fully conversant with the use of EDC in clinical trials
• Excellent interpersonal, communication and problem-solving skills
• Flexible in reacting to changing priorities in projects without compromising timelines and/or quality

Competencies

• Hard worker
• Ability to work on big projects as part of a team
• Good organisation and optimisation of working environment
• Ability to manage multiple projects and overlapping deadlines
• Natural ability to problem-solve
• Good communication skills, both written and verbal are required
• Ability to communicate with experimental biologists, computer scientists and non-scientists

How to apply

Submit your CV and Cover letter in a PDF format to [email protected]

Please label your CV according to the following example: James_Smith_CV

Please label your cover letter according to the following example: James_Smith_Cover_Letter