Director Clinical Operations Development

CT19, incorporated; Schweiz; Remote; CHF 180,000 - 250,000; Full time

Job summary

CT19, incorporated, is seeking a Director Clinical Operations Development Lead for Rare Diseases. You will own end-to-end development from FIH through orphan designation and launch, designing and revising trials and shaping the full development plan.

Reporting at franchise level, you’ll lead a small team of Clinical Trial Managers/Leads, collaborate with CROs, and quickly address delays or recruitment issues while maintaining strategic oversight in a fast-paced biotech environment.

Qualifications

• Strategic Clinical Operations experience including design & revision of trials at multiple phases of drug development.
• Experience leading and creating Clinical Development Plans for one or more indications.
• Proven leadership of Clinical Trial Managers/Leads in a director-level role.
• Experience in an outsourced model and collaboration with CROs.
• Rare Disease or Orphan Drug experience beneficial but not essential.

Responsibilities

• Design and revise clinical trials across development phases.
• Develop and revise the full development plan for indicated programs.
• Lead and mentor a team of Clinical Trial Managers/Leads; coordinate with CROs.
• Address delays and recruitment issues with hands-on operational input.
• Collaborate at a franchise level to ensure alignment with strategic objectives.

Job description

Director Clinical Operations Development Lead- Rare Disease

Location- Candidates must live in Switzerland

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.