Director Clinical Operations

Position Summary

Our start-up Biotech client are actively recruiting for a Director of Clinical Operations in their HQ in Zurich. This person will be accountable for the resourcing, development, training, and management of the clinical operations team. This is one of the first hires into the clinical unit, therefore the first 6-months will involve some hands-on project activities working closely with the CMO and CEO to ensure delivery of the current sites/studies.

Essential Duties and Responsibilities: Duties include but are not limited to: 

• Create, execute and proactively manage clinical trial processes. Provide leadership, strategic oversight, and guidance of Clinical Operations to ensure quality, timeline, resources and budget goals are met. stablish performance indicators and apply to ensure the successful execution of clinical trials to agreed timelines Ensure the effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated development plans and study protocols; interact and collaborate with other department heads as appropriate. Represent all aspects of Clinical Operations and provide updates as required to the Executive Committee, Project Teams, Board of Directors and other key internal stakeholders. Lead & mentor Clinical operations staff to support successful internal training and its implementation and serve as an advocate for professional development of Clinical Operations staff. Oversee, plan and implement Quality Checks for clinical projects and provide leadership and direction to ensure the highest standards for compliance with Company SOPs, ICH-GCP guidelines, Regulatory authority regulations and patient safety standards Mentor clinical operations staff on the Regulatory Inspections process and develop a pro-active approach for Inspection readiness Assist the QA department in the development, review and updating of IO clinical SOPs Accountable for the authorship of operational sections of protocols and investigator brochures and leading the identification of and interaction with investigative sites and investigators, including study execution. Develop and maintain strong relationships with CROs, external experts and Investigators to ensure effective execution of internal and external clinical projects. Provide support for regulatory submissions, supporting dossier development and participating in interactions with FDA, EMA and other regulatory agencies. Keep abreast of competitive regulatory and clinical practices and utilize this knowledge during the ongoing development and adjustment of plans.

Qualifications

• To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required or desirable.

Knowledge, Skills and Abilities

 Expertise in clinical operations – demonstrated ability to effectively manage projects and people. Proactive problem-solving abilities and follow-through

• Strong communication and presentation skills-demonstrates strong written and verbal communication skills and ability to relay vision/strong sense of department organization Experience leading a rapidly changing organization and integrating new personnel is essential, as well as ability to evaluate and resolve complex problems Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design, and data management methods. Self-motivated to maintain expertise in regulatory requirements and guidance to ensure that the Clinical Operations remains compliant with GCP and other global regulatory guidelines or laws For the best fit, you should be a results-oriented team player with strong interpersonal and communications skills, capable of working collaboratively with colleagues Work Environment: This is a high growth, fast paced small organization. 

By clicking “apply” you will be sending your CV to Alex Smith at Barrington James. Alex is a Specialist Clinical Operations/Development Recruiter with a strong background in recruitment and the life science field. Alex will discuss the opportunity in detail with you, facilitate your application and will manage the process acting as a link between the company and yourself. He will assist in all elements of the process, facilitate the offer process, keep in contact throughout your notice period and even catch up with you during your first week in your new role.

This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply without delay as it is likely that recruitment will close prematurely. Please direct all questions (if necessary) to Alex Smith at asmith@barringtonjames alongside a copy of your CV.

We are looking to put a shortlist together for this client, to highlight your interest please send your CV or an email to Alex Smith.