Director Clinical Operations Development

CT19; Massachusetts; Remote; USD 180,000 - 240,000; Full time

Job summary

CT19, incorporated is seeking a Director Clinical Operations Development Lead in a remote East Coast-based role with occasional European travel. You will design and revise trials across development phases and lead a small team, coordinating with CROs to advance Rare Disease programs.

The role combines strategic leadership with hands-on execution, ensuring timelines, recruitment, and quality standards are met in a fast-paced biotech environment.

Qualifications

• Strategic Clinical Operations experience including design & revision of trials across phases.
• Experience leading Clinical Trial Managers/Leads.
• Director level experience is required.
• Experience working in an outsourced model with CROs.
• Rare Disease or Orphan Drug exposure is beneficial but not mandatory.

Responsibilities

• Lead end-to-end development of clinical trials from FIH to launch.
• Oversee a small team of Clinical Trial Managers/Leads and coordinate with CROs.
• Develop and refine the development plan for one or more indications.
• Manage operational delivery while adapting to strategic changes in pipeline direction.

Skills

Strategic Clinical Operations

Clinical trial design

Leadership

CRO collaboration

Rare Disease experience

Job description

Director Clinical Operations Development Lead- Rare Disease

Location- Candidates must live in an East Coast state

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.