Job Detail

Chief Medical Officer

Inseriert am: 26.04.2018

Versantis AG
Technoparkstrasse 1
8005 Zurich



  • 41 44 633 06 72


or: +41 44 500 88 91
CAREER OPPORTUNITY career@versantis.ch


Chief Medical Officer


Are you seeking for broad and meaningful responsibilities in a patient-focused company? Do
you want to leave a mark and work in a dynamic and flexible environment? Join Versantis’ Senior
Executive team on its ambitious mission to revolutionize the care of patients with liver diseases.
You will be empowered to lead the clinical development and filing of Versantis’ flagship drug –
VS-01 – and take a key role in business development and alliance activities.


The company and lead asset


Versantis is a young pharmaceutical company globally innovating in the field of hepatology. We
are committed to developing lifesaving medicines in areas of unmet medical need, such as rare
diseases and severe liver impairments. Versantis has successfully raised private and public capital
and was rewarded with the most prestigious scientific and entrepreneurial prizes (MassChallenge
winner, 3x Top100, VentureKick, and Pfizer Research Award).
VS-01, Versantis’ lead candidate, will enter clinical stage this year and is developed for the
treatment of hepatic encephalopathy (HE) in patients with acute-on-chronic liver failure. VS-01 is
a proprietary liposomal fluid capable of enhancing the elimination of life-threatening metabolites
accumulating in liver-impaired patients. It received Orphan Drug Designations by both the FDA
and EMA and will be a first-line therapy to treat HE events or bridge patients to transplantation.


The position


The successful candidate will be a strategically minded, hands-on clinical development expert
with experience in defining and implementing early-stage clinical studies at high quality and in a
time- and cost-efficient manner. Patient-focus knowledge in hepatology, orphan drug
development experience, and hands-on management of technical aspects related to clinical
operations and regulatory filings are key aspects of the position. This is a unique opportunity to
be a major contributor to the success of a well-positioned, promising early-stage biotechnology
company.
Essential duties and responsibilities



  • Acting as a key member of the Senior Executive team, the candidate will work closely with
    the CEO and COO in a collaborative and welcoming environment.

  • Design and deploy clinical development plans and individual clinical trials (single and multi-
    centered) and develop contingency plans.

  • Budget responsibility; contract negotiation with all partners involved in the clinical trial
    process.

  • Author, assemble, and/or review protocols, investigator brochures, clinical study reports
    and clinical trial documents.

  • Conduct investigator meetings and lead site initiation visits with clinical trial investigators

  • Manage clinical trials from start up to close out: monitoring visits, recruitment and
    enrolment of patients, covering informed consent, eligibility and compliance with the
    protocol, lead CRAs, ensures the study logistics (randomization, supply, packaging and
    labeling), study drug accountability, protocol deviations. Apply clinical/medical decision
    making to clinical development issues.

  • Support data management: queries generation and resolution, track and follow-up on
    serious adverse events, eCRF review, eTMF, maintenance of Study Files...

  • Interact with FDA, EMA and other agencies (e.g. ,document preparation, coordination of
    meeting rehearsals and minutes…) and communicate with Ethics Committees.

  • Orchestrate, manage, and chair Versantis Medical Advisory Board meetings.

  • Represent the Company and its programs to external audiences, including the investors
    and medical communities as well as pharmaceutical or biotechnology industry partners.


Experience, knowhow, and desired characteristics



  • MD or MD/PhD with at least 5 years of experience in early clinical development experience
    in an industry setting.

  • Experience in hepatology preferred.

  • Demonstrated experience with design, successful execution, and analysis of Phase 1-2
    clinical studies

  • In depth knowledge of ICH guidelines and GCP, GLP regulations.

  • Solution-driven person with strong initiative and drive. Must be an organized, rigorous self-
    starter who is able to anticipate the company’s needs.

  • Comfortable in a fast-paced small company environment with minimal direction and able
    to define its own workflow and execute it independently, while handling multiple priorities.


Why should you apply?



  • You will actively contribute to the development of new potential life-saving medicines.

  • Your work will give you a sense of ownership as you directly contribute to Versantis’
    success.

  • As the company grows, your responsibilities will evolve towards a global and highly visible
    role, representing all clinical development programs and beyond. Each of your decision will
    have an impact on the future of the product, the company, and patients’ lives.

  • Young, dynamic, and flexible working environment with little bureaucracy – perfect for
    innovation to thrive!


If your profile matches the requirements of this exciting position, we are looking forward to
hearing from you. Please send us your detailed application (CV and documents in English and in
PDF) to: career@versantis.ch.

Details