We are now recruiting for a Director of Clinical Operations with a young start-up company, who are focused on advancing treatment options for orphan and rare diseases, in oncology. Reporting to the CEO, the Head of Clinical Operations will play a pivotal part in the company’s progression and expansion, ensuring activities are aligned with the company’s therapeutic and commercial vision.
The successful candidate will provide leadership and direction (non-medical) to Clinical Operations to ensure projects are delivered to agreed timescales, cost and quality; while providing complete management and oversight for the company’s clinical operations to ICH / GCP guidelines, company SOPs and all applicable regulations.
This hire will lead activities in preparing for and managing through a Phase III clinical trial for within oncology. This position requires a self-directed, dynamic leader with a passion for patients in this therapy area.
The ideal candidate will have strong clinical, leadership and communication skills, who is a hands-on leader willing to roll-up their sleeves in order to ensure the highest quality of work output. Collaboration & consensus-building skills; and a curious mind are essential for success in this role.
Bachelor’s degree (or equivalent) in a scientific or health-related field
Minimum 8+ years clinical research experience with 4+ years in a managerial role with a Biotech, Pharma or CRO company.
Thorough understanding of drug development clinical and regulatory processes in EU, US and other global regions. Strong working knowledge of FDA, EMA, PMDA regulations and expectations, GCP, ICH guidelines, and clinical operations best practices.
Experience and knowledge of end-to-end management of clinical trial conduct, clinical trials operations, vendor oversight and regulatory components is essential.
Proven success in leading and coordinating cross-functional clinical operations teams. (e.g., clinical operations, data management, clinical supply chain).
Demonstrated leadership behaviours with ability to accept challenges, seek opportunities to remove barriers, and lead in areas of uncertainty.
Demonstrated ability to influence others, both internally and externally, in order to create a positive working environment.
Previous experience with orphan/rare diseases and combination drug studies, a plus.
Previous experience with submission of marketing approval applications, a plus.
Fluent in English.
Willing to travel to support clinical activities (circa 10%).
Please contact Larry on +353 (0) 1 2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. http://www.rftgroup.ie/
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