Company: Juvabis AG
Location: Zürich, ZH

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Stellenbeschreibung
Anstellungsart
Temporary
Vollständige Stellenbeschreibung

The Swiss start-up company Juvabis develops next-generation aminoglycoside antibiotics that withstand mechanisms of bacterial drug-resistance and at the same time display superior drug safety due to increased target selectivity by rational design. Juvabis has been founded around a proprietary technology developed by researchers at the University of Zurich, and a pipeline of drug candidates discovered in collaboration with researchers at the ETH Zurich and Wayne State University in Detroit.
Since June 2016, Juvabis has been a partner in the ENABLE consortium. The ENABLE project within IMI’s New Drugs for Bad Bugs (ND4BB) programme develops antibacterial drug candidates for testing in the clinic, bringing the possibility of new therapeutics for systemic Gram-negative infections one step closer to patients.

Juvabis now seeks a Head of Clinical Development & Regulatory Affairs to continuously strengthen and drive new product clinical development strategy with her/his medical and scientific expertise in a collaborative effort with various stakeholders with the current focus on early clinical development Phase 1 trials (Juvabis/ENABLE press release of October 2018). Start date: as soon as possible upon mutual agreement.

The primary focus of the work is to:

· Provide development leadership and strategic input for all deliverables in a clinical program

· Lead clinical development plan preparation and define clinical program level activities

· Lead certain clinical and regulatory program activities (e.g. submissions, briefing books) and/or clinical trials

Principal Accountabilities and Tasks

· Ensures Juvabis has appropriate processes and resources in place to manage clinical Product Development activities and has responsibility for clinical development program related decisions

· Overall accountability for timely and accurate execution of clinical operations activities, e.g. clinical trial management, outsourcing strategy, an IMP recall, etc.

· Provides guidance to the clinical operations team and contributes to the on-boarding and scientific/QMS training

· Manages the regulatory aspects and tasks required for a clinical trial including submissions and interactions with Health Authorities

· Lead 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 Juvabis` 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

· Supports CMC activities planning and management

· Oversees outsourcing activities and designates outsourcing project responsible

Education and Experience Required

· 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 with antibiotics development is of advantage

· Experience in a small company environment

Skills and Competencies Required

· 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

· Pronounced ability to challenge the status quo, investigate and offer new solutions

· Delivering results with the balanced speed, quality, and value

Financial responsibilities and accountability

· Oversees development of a clinical trial project/program operating budget and overall adherence to the budget throughout project/program duration (including reviews of relevant invoices if applicable)

· Escalates issues and advices on any significant financial matters arising

We offer

· Highly stimulating working environment with great flexibility regarding work schedule and location, possibility for home-office

· Exciting company culture instilled with integrity, intensity and involvement

Job Type: Temporary