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Director Clinical Operations

3 months ago

England, UK, United Kingdom i-Pharm Consulting Full time

Position: Director of Clinical Operations - Ophthalmology (Full Time Contract/Consultant) - Biotechnology Company

Location: Preferred in the UK (Ideally London) or within the EU


Summary:

This role involves collaborating with the Executive Director of Global Clinical Operations to support and oversee clinical studies, focusing on ophthalmology. The role includes leadership responsibilities, ensuring clinical trials align with protocols, SOPs, GCPs, and regulatory requirements, and serving as a key liaison with CROs and other vendors.

Key Responsibilities:

Overseeing the execution of multiple clinical trials.
Providing strategic guidance to study teams to achieve organizational objectives.
Managing vendor budgets and contracts.
Tracking and reporting study metrics.
Identifying and mitigating risks related to study implementation and compliance.
Building and maintaining relationships with investigators and key opinion leaders.
Offering technical expertise in developing clinical documents and conducting trials.
Staying updated with industry practices and regulatory requirements.
Regularly communicating with stakeholders including Regulatory, Clinical Development, Legal, and Finance.
Leading the selection process for CROs and attending key meetings to ensure study goals are met.
Contributing to the development and implementation of clinical operations initiatives.
Potential travel up to 30% for clinical study activities.

Qualifications:

Bachelor's or Master's degree in a related field or equivalent experience.
Extensive experience leading clinical trial operations in a senior role, with a focus on ophthalmology drug development.
At least 10-15 years of experience in clinical trial operations, including multinational studies.
Strong leadership and management skills.
Comprehensive knowledge of the clinical development process and regulatory requirements.
Proven success in managing outsourced clinical operations services and vendors.
Financial budgeting or reporting experience.
Ability to effectively interact with various stakeholders at all levels of the organization.

Company Overview:

This biopharmaceutical company specializes in developing treatments for neuroinflammatory diseases. They are advancing clinical trials with the aim of delivering new treatments to patients swiftly.

Equal Opportunity Employment:

The company values diversity, equity, inclusion, and belonging. They ensure a supportive work environment where all employees, regardless of background, can thrive.

Desired Skills and Experience

Position: Director of Clinical Operations - Ophthalmology (Full Time Contract/Consultant) - Biotechnology Company

Location: Preferred in the UK (Ideally London) or within the EU

Summary:

This role involves collaborating with the Executive Director of Global Clinical Operations to support and oversee clinical studies, focusing on ophthalmology. The role includes leadership responsibilities, ensuring clinical trials align with protocols, SOPs, GCPs, and regulatory requirements, and serving as a key liaison with CROs and other vendors.

Key Responsibilities:

Overseeing the execution of multiple clinical trials.
Providing strategic guidance to study teams to achieve organizational objectives.
Managing vendor budgets and contracts.
Tracking and reporting study metrics.
Identifying and mitigating risks related to study implementation and compliance.
Building and maintaining relationships with investigators and key opinion leaders.
Offering technical expertise in developing clinical documents and conducting trials.
Staying updated with industry practices and regulatory requirements.
Regularly communicating with stakeholders including Regulatory, Clinical Development, Legal, and Finance.
Leading the selection process for CROs and attending key meetings to ensure study goals are met.
Contributing to the development and implementation of clinical operations initiatives.
Potential travel up to 30% for clinical study activities.

Qualifications:

Bachelor's or Master's degree in a related field or equivalent experience.
Extensive experience leading clinical trial operations in a senior role, with a focus on ophthalmology drug development.
At least 10-15 years of experience in clinical trial operations, including multinational studies.
Strong leadership and management skills.
Comprehensive knowledge of the clinical development process and regulatory requirements.
Proven success in managing outsourced clinical operations services and vendors.
Financial budgeting or reporting experience.
Ability to effectively interact with various stakeholders at all levels of the organization.

Company Overview:

This biopharmaceutical company specializes in developing treatments for neuroinflammatory diseases. They are advancing clinical trials with the aim of delivering new treatments to patients swiftly.

Equal Opportunity Employment:

The company values diversity, equity, inclusion, and belonging. They ensure a supportive work environment where all employees, regardless of background, can thrive.