Job Description
Our client, a young and fast growing innovative drug discovery company based in Dublin, with novel platform technology which provides innovative solutions to help treat people with unmet needs, now seek to expand their team with a new senior post - Head of Clinical Operations. The successful candidate will be an experienced Head of Clinical Operations within the Biopharma/Pharma industry and who can be a pioneer in their field.
This role offers an opportunity for someone who is seeking to accelerate their career in a diverse, fast-moving, growing and innovative company. This role offers exposure to and working closely with the CSO as well as key stakeholders.
The ideal candidate will provide in-depth scientific expertise required for the clinical design and development of compounds, liaising with Commercial and other areas of the company integrating, defining and weaving clinical requirements into overall company strategy and vice versa.
Responsibilities of Head of Clinical Development & Operations:
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.
Requirements of Head of Clinical Development & Operations:
Relevant Science degree. Advanced Qualifications is preferred.
10+ years of experience in managing/co-managing multi-centre clinical trials, majority of which in Pharma / Biotech industry.
Demonstrable experience in designing and implementing trials to ICH/GCP guidelines.
Proven experience working in partnership and managing CROs, and other vendors.
Monitoring and project management experience.
Ability to audit and clinical trial sites.
A flair for scientific writing (protocols and reports).
Fully conversant with the use of EDC in clinical trials.
Flexible in reacting to changing priorities in projects without compromising timelines and/or quality.
Excellent interpersonal, communication and problem-solving skills.
Candidate must be self-motivated, hands-on and willing to travel.
Ability to solve problems, with strong scientific nous and commercial acumen.
Please phone Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, Biopharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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