Job description

BioVersys AG is a privately owned clinical-stage Swiss pharmaceutical company focusing on research and development of small molecules acting on novel bacterial targets with applications in antimicrobial resistance (AMR) and targeted microbiome modulation. With the company’s award-winning TRIC technology we can overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. By this means, BioVersys addresses the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. Our most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase II-ready), and tuberculosis (BVL-GSK098, Phase I) in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille.

BioVersys is located in the Technologiepark in the biotech hub of Basel and is looking for a

Medical director

to join its team in Basel, Switzerland.

The Medical Director will have overall responsibility for providing medical/clinical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this role acts as the BioVersys medical expert and will serve as a medical/clinical resource for the review, presentation, and interpretation of results in the Clinical Study Report. The Medical Director will also be involved in the development of new clinical projects, including study design, protocol, and project plans as required.

The responsibilities for this role include the following:

  • Provide clinical leadership and responsible for timely execution of all clinical deliverables. Clinical deliverables include individual protocols, clinical components of regulatory documents/registration dossier and brand related medical information, clinical communication and publications.
  • Be the primary contact for medical review of clinical safety information from clinical trials and work closely with associates in evaluation and assessment of trial safety information and pharmacovigilance.
  • Provide expert medical and scientific input to clinical trial documents and regulatory documents and dossier.
  • Provide scientific input into trial/program level documents such as protocols and related documents, IBs, briefing books for health authority meetings, PIPs, clinical overviews and summaries, depending on status of development
  • Write and/organize writing and/or review of study-related documents (protocol outline, protocol and protocol amendment, Informed Consent, Statistical Analysis Plan, Clinical Study Report, manuscript for publication). Answers medical/scientific inquiries from IEC/IRB and/or Health Authorities
  • Drive execution of the section of the clinical program in partnership with stakeholders (e.g., Clinical Operations, CRO)
  • Contribute to manage trial committees and advisory boards
  • Develop a sound understanding of the science and medicine related to trials and programs
  • Coordinate with internal/external parties in all phases of the studies and trials including feasibility assessments, design processes, educational efforts, management of medical information, and reviewing and editing of medical documents;
  • Follow specific research related protocol and lead others in strict adherence to the policies.
  • Reports to the Chief Development Officer

The successful candidates required competencies and skills:

  • Medical degree with board certification preferred.
  • Minimum of 5 years of involvement in clinical research and development in a pharmaceutical company or biotech spanning several clinical development phases (e.g. planning, setting-up, conducting, closing, and reporting). Experience in clinical Phase 2 preferred.
  • Infectious disease knowledge necessary
  • Excellent organizational ability and flexibility, with attention to details
  • Innovative, critical and entrepreneurial thinking with ability to organize and prioritize and to motivate teams and colleagues
  • Excellent and up-to-date knowledge of the ICH and Good Clinical Practice standards
  • Having practiced medicine in an intensive care unit environment advantageous
  • Be able to be "hands-on" and thrive in a direct and uncomplicated setting
  • Highest personal values and ethical standards

Starting date: July 1st, 2022 or to be agreed upon.

Do you want to make a significant contribution to the continued success of BioVersys AG?

If this challenge attracts you, we look forward to receiving your complete application documents (CV, diplomas, certificates, cover letter, including contact information of two references) and possible start date by email to: Eliane Schmidt, jobs@bioversys.com

 

Location

Hochbergerstrasse, Basel, Switzerland

Contact information