Director Clinical Operations Development

CT19, incorporated; Belgique; A distancia; EUR 120.000 - 180.000; Jornada completa

Descripción de la vacante

CT19, incorporated is seeking a Director Clinical Operations Development Lead for Rare Disease. The role is remote with occasional travel to Europe HQ; candidates must reside in Belgium.

You will oversee end-to-end trial design and development plans from FIH to orphan designation and launch, leading a small team and coordinating with CROs in a fast-paced biotech setting. The role combines strategic and hands-on operational work, requiring the ability to adapt to pipeline changes while driving

Formación

• Strategic Clinical Operations design and revision of trials across phases of drug development.
• Experience in creating Clinical Development Plans for one or more indications.
• Proven leadership of Clinical Trial Managers/Leads in prior roles.
• Director-level experience is a necessity for this role.
• Experience working in an outsourced model with CRO partners is required or highly beneficial.

Responsabilidades

• Own end-to-end responsibilities of an indication from FIH through designation and launch.
• Design and revise clinical trials and assess parallel trial strategies.
• Develop and support the full development plan for indications.
• Lead a small team of Clinical Trial Managers/Leads and coordinate with CROs.

Conocimientos

Strategic Clinical Operations

Clinical Development Plan

Leadership

Director level experience

Outsourced model & CRO collaboration

Rare Disease/Orphan Drug experience (a

Descripción del empleo

Director Clinical Operations Development Lead- Rare Disease

Location- Candidates must live in Belgium

Remote role and occasional travel to HQ in Europe may be required

About the Company

We are working with a European biotech organisation, who are developing novel therapeutics for a range of rare diseases. They have achieved FDA success with a few of their programs, which have launched into further markets around the world. The portfolio ranges from preclinical to approved products, with multiple new indications currently being explored. With such an expansion in pipeline, there is now a need to recruit multiple positions across the Clinical functions.

About the Role

This role is an exciting opportunity to join as a Clinical Operations Development Lead. Reporting into Franchise level, you will be responsible for full end-to-end responsibilities of an indication, quite often from FIH through to orphan designation & launch. You will sit at a senior strategic level, focused on designing & revising clinical trials, evaluate what trials can be carried out concurrently, and support in the design of the full development plan. This role is a unique combination of strategic & operational work, as you will often need to jump in to solve any delays or recruitment issues. You will also lead a small team of Clinical Trial Managers & Leads, who collaborate directly with the CRO.

About the Candidate

We are looking for candidates who have the below experience:

• Strategic Clinical Operations experience, which must include the design & revision of clinical trials at different phases of drug development
• Experience of leading & creating a Clinical Development Plan for 1 or more indications
• Proven leadership experience, having managed Clinical Trial Managers/Leads in a previous role
• Prior experience at Director level is a necessity
• Experience in an outsourced model, including collaboration with CROs
• Rare Disease or Orphan Drug experience will be beneficial but not essential
• A willingness to work operationally and "hands-on" when required to get tasks completed
• A desire to work in a biotech environment which can be fast-paced & demanding, whilst also being able to adapt to any strategic changes in pipeline direction.