Head of Clinical Development & Regulatory Affairs
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Hobson Prior are looking for a Head of Clinical Development & Regulatory Affairs to join a clinical-stage biopharmaceutical company in Zurich. This position will be accountable for to strengthen and drive new product clinical development strategy in a collaborative effort with various stakeholders with the current focus on early clinical development Phase 1 trials.
- Ensures the organisation has appropriate processes and resources in place to manage clinical Product.
- Development activities and has responsibility for clinical development program related decisions.
- Manages the regulatory aspects and tasks required for a clinical trial including submissions and interactions with Health Authorities.
- Overall accountability for timely and accurate execution of clinical operations activities, e.g. clinical trial management, outsourcing strategy, an IMP recall, etc.
- Supports CMC activities planning and management.
- Provides guidance to the clinical operations team and contributes to the on-boarding and scientific/QMS training.
- You will lead the development of trial and program level regulatory documentation (e.g., sections of study protocols, Investigator's Brochures, briefing books, submission dossiers, and responses to Health Authorities).
- Supports relevant external stakeholders with training on the scientific/medical aspects of the compound.
- Has overall ownership of the company's quality management system, approves and endorses QA Plans, provides input and feedback to QA and audit plans.
- Representing the project and providing subject matter input for the management of all QMS aspects
- Communicates issues to management and designate a Compliance responsible person to investigate issues related to compliance with SOPs and with regulatory guidelines.
- Ensures the Inspection Readiness program gets initiated and closed as per plan: oversees and makes a final decision on the implementation of Inspection / Audit Readiness activities and tasks for his functional area.
- Oversees outsourcing activities and designates outsourcing project responsible.
- Strong leadership and accountability.
- Translation of strategy into operational objectives and goals.
- Strong ability to communicate effectively on medical/scientific issues, maintain a big-picture and build consensus.
- Excellent written and verbal communication skills (in English, and, of advantage, German).
- Outstanding capacity to coordinate multiple activities simultaneously.
- Extensive work experience in clinical drug development.
- Extensive work experience designing and managing early phase clinical studies or complete clinical programs.
- Profound operational and regulatory knowledge of interventional clinical studies with IMPs (both with the US and Europe-located trials).
- GCP certification.
- Experience in submissions and scientific advice interactions with regulatory authorities.
- Experience in a small company environment.
- Experience with antibiotics development is of advantage.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.