Execuitve Director, Clinical Development
Execuitve Director, Clinical Development
Opthea
United States
See who Opthea has hired for this role
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.
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Seniority level
Director -
Employment type
Full-time -
Job function
Other -
Industries
Biotechnology Research
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See who you knowFeatured Benefits
Inferred from the description for this job
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Medical insurance -
Dental insurance -
Vision insurance -
401(k) -
Disability insurance
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