Careers

Together with a team of skilled scientists and drug development professionals, Vico’s focus is on development of RNA modulating therapies for rare neurological disorders, with initial focus on SCA – Spinocerebellar ataxiaHD – Huntington’s disease and RETT syndrome.

The team has a long standing expertise in antisense oligonucleotide technology and a majority of our employees have worked most of their professional careers on RNA-modulating therapeutics for rare diseases. Our passion never dies in the mission to bring a therapy to the patients.

Interested in joining us?

Career opportunities

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Clinical Project Manager

Vico Therapeutics is a biopharmaceutical company focusing on developing oligonucleotide-based therapies for CNS disorders, bringing decades of experience in RNA modulation technology and science together.

The Company has a highly experienced leadership team with a successful track record in research, drug development, manufacturing, operations, and business development. Vico’s employees are self-motivated, high-performing professionals who all share the desire to grow, both individually as well as together, by providing exceptional contributions to the organization. In addition, the company has established a firm network of accomplished advisors with deep experience in pharmaceutical research and development to ensure quick complementary expertise in all relevant areas.

Vico is seeking a Clinical Project Manager with passion and desire to become part of an innovative, experienced team committed to developing new therapeutic solutions for rare, neurodegenerative diseases caused by genetic alterations. You will be an integral member of Vico’s Clinical Group that consists of highly motivated professionals with deep knowledge and experience in drug development, clinical operations, translational medicine, regulatory, drug safety, and medical affairs. The team is responsible for the successful planning and execution of the Company’s lead asset clinical program in several indications in a cost-effective, safe, and compliant manner, and to provide clinical guidance for research and preclinical projects. 

The Clinical Project Manager manages assigned Clinical Project Management / Clinical Operations activities, to ensure timely initiation, execution and reporting of clinical projects and trials, at the highest quality and in adherence with all applicable regulations.

It is essential that the individual selected for this position is an effective and collaborative team player as well as capable to work independently and to quickly establish rapport and credibility with key internal and external stakeholders.

The selected candidate will work directly with Vico’s Head of Clinical Project Management / Head of Clinical Operations and with Vico’s Chief Medical Officer.

Responsibilities

An integral member of the Clinical Group managing the planning and conduct of clinical development projects and clinical trial activities. Specifically, he/she

  • Develops or provides medical, development and operational input to the development of clinical trial and project documents including clinical development plans, clinical study protocols, investigator’s brochures, risk assessments, study-specific plans and manuals;
  • Implements, leads, or supports the project team and/or the clinical/study team, or respective sub-teams. Actively drives the proper identification and the setup of such teams to execute, track, and report project and study activities;
  • Manages or supports clinical (or preclinical) studies run by CROs during commissioning, at study start, during the study including the day-to-day operational management, and at study closure, including the development of vendor specifications, the review of vendor reports, budgets, metrics, and the timely escalation of risk to timelines and budget if needed in order to ensure that performance expectations are met;
  • Oversees monitoring activities at clinical CROs by reviewing visit reports, and any protocol deviations; attend monitoring visits as required;
  • Actively provides support to other members of the Clinical Group and to Clinical Project Management / Clinical Operations colleagues;
  • Supports the interface management and the preparation/conduct of meetings with external collaborators including local site investigators and applicable study committees;
  • Leads the identification and management of operational tracking needs, including budget tracking; regularly communicates the study status and timelines and escalates unresolved issues appropriately;
  • Responsible for the implementation of contingencies and measures to overcome operational challenges, in consultation with line management;
  • Oversees the timely supply of all materials (from internal and external parties) to sites and CRO/vendors;
  • Ensures that assigned studies are conducted according to company SOPs, ICH and regulatory authority standards, specifically including GCP requirements;
  • Provides summaries for clinical and/or preclinical study results, based on raw data or summary figures generated by external collaborators and CROs;
  • Ensures the timely delivery of project and study documents e.g. Clinical Study Reports and regulatory documents;
  • Coordinates or supports the submission of documents for authority consultations, and the reply to study questions or issues from Health Authorities or EC/IRBs;
  • Participates in developing the clinical, scientific, and operational network including consultants, CROs, vendors;
  • Responsible for setting up archives for essential documents including Trial Master File and ensures proper filing of essential documents in these systems.

Additional tasks in case of medical qualification:

  • Clinical / medical assessments on project and study level, including indication evaluations, benefit-risk assessments and medical monitoring / medical reviews.

Requirements

  • Bachelor / M.S. (and/or higher) degree in life sciences or a related scientific field
  • Proven project management and clinical development experience of at least 5 years in management of operational (possibly: and medical) aspects of conducting clinical trials, including trial design, trial organization, development of timelines, budgets and resource plans
  • Experience across a range of therapeutic areas
  • Experience of leading clinical trial teams, also in a virtual setting (online meetings)
  • Experience in working with vendors (CROs, IVRS, central laboratories, etc.)
  • Strong understanding of FDA/EMA/ICH guidelines and industry standard practices regarding clinical development and trial management
  • Proven ability to successfully achieve results within a multifunctional, multicultural and geographically diverse team
  • Excellent written and verbal interpersonal communication, influencing and customer care skills demonstrated by an ability to present clear instruction/direction to team members
  • Excellent organization and tracking skills, as well as attention to detail
  • Documented training in and experience working with GCP
  • Mandatory fluent English (both oral and written) – other languages are an asset.
  • Capable to work at the office in Leiden, the Netherlands, on regular terms and on demand, if required. Part-time home office work possible.
  • Available for approximately 25% of time for further travel, both domestic and international, including overnight stays.

Application:

If you think you have the right skills and experience, and a wish to join a highly motivated team with a passion for science, we invite you to send your resume and motivation letter to: desiree.vanbalen@vicotx.com. Please indicate the title of the position in the subject line of the email: Clinical Project Manager.

We thank all applicants for their interest, however, only those selected will be invited for an interview.

NB: we collect personal data for selection purposes only. All personal data will be destroyed within 4 weeks after completion of the procedure.  

Head of Clinical Project Management / Head of Clinical Operations

Vico Therapeutics is a biopharmaceutical company focusing on developing oligonucleotide-based therapies for CNS disorders, bringing decades of experience in RNA modulation technology and science together.

The Company has a highly experienced leadership team with a successful track record in research, drug development, manufacturing, operations, and business development. Vico’s employees are self-motivated, high-performing professionals who all share the desire to grow, both individually as well as together, by providing exceptional contributions to the organization. In addition, the company has established a firm network of accomplished advisors with deep experience in pharmaceutical research and development to ensure quick complementary expertise in all relevant areas.

Vico is seeking a Head of Clinical Project Management / Head of Clinical Operations with passion and desire to become part of an innovative, experienced team committed to developing new therapeutic solutions for rare, neurodegenerative diseases caused by genetic alterations. You will be a leading member of Vico’s Clinical Group that consists of highly motivated professionals with deep knowledge and experience in drug development, clinical operations, translational medicine, regulatory, drug safety, and medical affairs. The team is responsible for the successful planning and execution of the Company’s lead asset clinical program in several indications in a cost-effective, safe, and compliant manner, and to provide clinical guidance for research and preclinical projects.

The Head of Clinical Project Management / Head of Clinical Operations is a key position responsible for all aspects of Clinical Project Management / Clinical Operations activities. He/she will provide operational expertise and leadership within the Clinical group to ensure timely initiation, execution and reporting of clinical projects and trials, at the highest quality and in adherence with all applicable regulations.

It is essential that the individual selected for this position is an effective leader and a collaborative team player, capable to work independently and to quickly establish rapport and credibility with key internal and external stakeholders.

The selected candidate will work directly with Vico’s Chief Medical Officer.

Responsibilities

An integral member of the Clinical Group leading or managing the planning and conduct of development projects and clinical trial activities. Specifically, he/she:

  • Leads the development, develops or provides medical, development and operational input to the development of clinical trial and project documents including clinical development plans, clinical study protocols, investigator’s brochures, risk assessments, study-specific plans and manuals;
  • Implements, leads, or supports the project team and/or the clinical/study team, or respective sub-teams. Actively drives the proper identification and the setup of such teams to execute, track, and report project and study activities;
  • Leads or manages clinical (or preclinical) studies run by CROs during commissioning, at study start, during the study including the day-to-day operational management, and at study closure. This includes the development of vendor specifications, the review of vendor reports, the planning and tracking of budgets and metrics, and the timely escalation of risk to timelines and budget if needed in order to ensure that performance expectations are met;
  • Oversees monitoring activities at clinical CROs by reviewing visit reports, and any protocol deviations; attend monitoring visits as required;
  • Actively supports other members of the Clinical Group;
  • Leads and/or provides guidance to other members of the Clinical Project Management / Clinical Operations;
  • Leads or supports the interface management with internal functions and external partners and the preparation/conduct of meetings with external collaborators including local site investigators and applicable study committees;
  • Establishes and manages the interactions with patients’ organizations;
  • Ensures that operational tracking needs are identified and appropriately managed; regularly communicates the study status and timelines and escalates unresolved issues appropriately;
  • Responsible for the implementation of contingencies and measures to overcome operational challenges, in consultation with line management;
  • Oversees the timely supply of all materials (from internal and external parties) to sites and CRO/vendors;
  • Ensures that assigned studies are conducted according to company SOPs, ICH and regulatory authority standards, specifically including GCP requirements;
  • Provides summaries for clinical and/or preclinical study results, based on raw data or summary figures generated by external collaborators and CROs;
  • Ensures the timely delivery of project and study documents e.g. Clinical Study Reports and regulatory documents;
  • Coordinates or supports the submission of documents for authority consultations, and the reply to study questions or issues from Health Authorities or EC/IRBs;
  • Participates in developing the clinical, scientific, and operational network including consultants, CROs, vendors;
  • Responsible for setting up archives for essential documents including Trial Master File, and ensures proper filing of essential documents in these systems;

Additional tasks in case of medical qualification:

  • Clinical / medical assessments on project and study level, including indication evaluations, benefit-risk assessments and medical monitoring / medical reviews;

Requirements

  • D. or M.S. (or equivalent) in applicable area, and/or Medical Doctor
  • Proven clinical development experience of at least 10 years in management of operational (possibly: and medical) aspects of conducting clinical trials, including trial design, trial organization, development of timelines, budgets and resource plans
  • Experience across a range of therapeutic areas
  • Experience of leading clinical trial teams, also in a virtual setting (online meetings)
  • Experience in working with and through vendors (CROs, IVRS, central laboratories, etc.)
  • Experience in people management, including reports
  • Strong understanding of FDA/EMA/ICH guidelines and industry standard practices regarding clinical development and trial management
  • Proven ability to successfully achieve results within a multifunctional, multicultural and geographically diverse team
  • Excellent written and verbal interpersonal communication, influencing and customer care skills demonstrated by an ability to present clear instruction/direction to team members
  • Excellent organization and tracking skills, as well as attention to detail
  • Documented training in and experience working with GCP
  • Mandatory fluent English (both oral and written) – other languages are an asset.
  • Capable to work at the office in Leiden, the Netherlands, on regular terms and on demand, if required. Part-time home office work possible
  • Available for approximately 25% of time for further travel, both domestic and international, including overnight stays

Application:

If you think you have the right skills and experience, and a wish to join a highly motivated team with a passion for science, we invite you to send your resume and motivation letter to: desiree.vanbalen@vicotx.com. Please indicate the title of the position in the subject line of the email: Head pf CPM/ClinOps.

We thank all applicants for their interest, however, only those selected will be invited for an interview.

 

NB: we collect personal data for selection purposes only. All personal data will be destroyed within 4 weeks after completion of the procedure.

Interested?

If you are interested in joining our mission to continuously discover, develop and deliver therapies then please send your full resume and application to desiree.vanbalen@vicotx.com or submit it via the contact form.

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