Execuitve Director, Clinical Development

Position Overview:

The Executive Director, Clinical Development will play a pivotal role in leading the development strategy and execution of key clinical program deliverables for the wet AMD program. Working closely with cross-functional teams, this individual will drive clinical programs forward, ensuring successful achievement of critical milestones.

Position Responsibilities:

Leadership in Masked Medical Monitoring:

• Oversee masked medical monitoring, including CRO oversight and PV function.
• Conduct individual and aggregate data reviews.

Cross-Functional Clinical Trial Team Leadership:

• Lead cross-functional clinical trial teams and global clinical teams.
• Execute development plans and deliver key study conduct and milestones.

Collaboration with External Experts:

• Engage with external experts, including managing the Study Steering Committee.
• Facilitate investigator meetings and provide support to principal investigators and study sites as needed.

Inspection Readiness and Regulatory Support:

• Ensure inspection readiness for health authority interactions.
• Provide regulatory support as required.

Clinical Review and Accountability:

• Conduct clinical review of study protocols, analysis plans, presentations, and publications.
• Be accountable for clinical project timelines and budget.

Data Generation and Medical Affairs Contribution:

• Support and contribute to data generation activities in collaboration with medical affairs.

Perform other duties as assigned.

Position Qualifications

Education and Certification Requirements

• Healthcare professional degree (MD preferred) with minimum of 5 years professional experience in Clinical Development
• Proven track record of experience and leadership in drug development (retina preferred)
• Knowledge of global safety regulations, GCP, ICH Guidelines, and other applicable regulatory guidance documents

Qualifications & Skills

• Demonstrated ability to build and maintain positive relationships with management, peers, co-workers, vendors, business partners, etc.
• Candidates with well-established networks and active relationships with clinicians in the ophthalmology community will be preferred.
• Strong verbal and written communication skills; including ability to clearly present information and respond to questions from project teams and vendors.
• Strong attention to detail and organization with the ability to manage large volumes of information and competing priorities.
• Must possess strong critical thinking, analytical and data presentation skills..
• Ability to energetically embrace responsibilities and demonstrate ability to achieve goals.
• Strong initiative with ability to function well as part of a cross-functional team.
• Experience in a start-up environment highly preferred.
• Moderate travel will be required - ability to travel 30-50%.

Compensation

An attractive compensation package will be offered to the successful candidate. It will include a competitive base salary, incentive bonus, and equity. A benefits package customary to the position will also be provided including 401k match, medical, dental, vision insurances and other benefits.

Opthea is an equal opportunity employer.