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Medical Director, Ophthalmology - Boston, United States - Aura Biosciences
Description
ABOUT AURA:
Aura Biosciences is a clinical stage oncology company.
We are developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively, while activating the immune system to create long lasting anti-tumor immunity.
We have a goal of developing this technology in multiple cancer indications, focusing initially on two therapeutic areas - ocular oncology and bladder cancer - with a goal to expand into other areas of solid tumor oncology.
Initially we have focused our clinical development in the medical field of ocular oncology, a group of rare diseases that have no drugs approved.
We are in Phase 3 with our lead VDC AU-011 in choroidal melanoma. We are also in development in non-muscle invasive and muscle invasive bladder cancer, currently in a Phase 1 trial.
We have commenced a global Phase 3 program investigating the delivery of AU-011 for the treatment of small choroidal melanoma and indeterminate lesions.
AU-011 has to date demonstrated an excellent efficacy and safety profile in Phase 2 for choroidal melanoma, and enrolment is ongoing in the pivotal Phase 3 trial.
SUMMARY:
Aura is seeking an experienced and collaborative ophthalmologist with extensive clinical trial experience to help execute the Ocular Oncology Therapeutic Area (TA) strategy.
Reporting to the Therapeutic Area Head - Ocular Oncology, this is a role that requires proven abilities to drive research and development, strategic innovation, and measurable business outcomes.
The incumbent's track record of therapeutic expertise will be extensive and play a key role in the current and future business success of Aura Biosciences.
RESPONSIBILTIES:
Provide significant input on clinical development plans, trial designs, clinical trial execution, medical governance and monitoring in the Ocular Oncology TA.
Serve as Medical Lead/Medical Monitor for assigned clinical trials/programs and ensure support of operational trial execution for Clinical Operations, Regulatory Affairs, Devices, Data Management, Statistics and other clinical trial team functions, with active participation on cross-functional development teams.
Accountable for ethical conduct of studies in the Ophthalmology/Oncology therapeutic area.Assist in preparation of clinical sections of regulatory documents (INDs, IND annual reports, briefing packages, etc.); collaboratively prepare for meetings with FDA/EMA
Stay current with GCP and regulatory requirements in the preparation and review of the clinical submission in the US and EU for drug and device.
Champion clinical excellence in the therapeutic area.Manage and maintain strong effective relationship with key external stakeholders and partners, key opinion leaders, investigators, consultants, patient advocacy groups as well as external clinical trial participants to demonstrate the primary goals of clinical development in all programs.
Support design and execution of investigator meetings and participate in site visits with Clinical trial investigators when needed.Explore opportunities for simplification, ensuring that the therapeutic area is as effective and efficient as possible.
QUALIFICATIONS:
MD with Board Certification, Board Certification in Ophthalmology required.
5+ Years of clinical experience (post completion of training) in Ophthalmology (Retina or Ocular Oncology a plus)
Prior experience in industry/biotech/pharma setting is a must.
Extensive experience in industry Research & Development, ranging from Phase 1 to Phase 4, with experience in filings and submissions in the US and RoW
Proven ability to strategize, prioritize and manage multiple projects simultaneously to ensure quality, timely, on target and within budget of accomplished tasks.
Attention to detail while discriminating between critical and non-critical activities and to follow established processes when identifying areas process improvement.
This person will have an entrepreneurial approach and have a 'roll up your sleeves and get it done' approach that is critical in biotech.
Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills.Excellent planning, time management, and organizational skills.
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