Executive Director/Vice President, Clinical Development, Ocular Oncology

ABOUT AURA:

At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies.

We are focusing the initial development of our VDC technology platform to treat tumors of high unmet need in ocular and urologic oncology. AU-011, our first VDC candidate, is being developed for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved. Beyond primary choroidal melanoma, we are developing AU-011 in additional Ocular Oncology indications, including choroidal metastases. Leveraging our VDCs’ broad tumor targeting capabilities, we also plan to initiate a clinical program in non-muscle invasive bladder cancer, or NMIBC, our first non-ophthalmic solid tumor indication.

SUMMARY:

Aura is seeking an experienced, collaborative, strategic Ophthalmology/Oncology executive to build and realize a future-oriented vision for the Ocular Oncology portfolio by helping build and execute this Therapeutic Area (TA) strategy.  Reporting to the Chief Medical Officer, this is a leadership 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:

• Provides leadership to the Ocular Oncology therapeutic area. This includes continual ownership of R&D for the TA, optimization of the organizational design and resources., ownership of and optimization of key processes, talent and succession management
• Developing Clinical Development plans, trial designs, clinical trial execution, medical governance in the TA.
• Responsible for overall pipeline and portfolio delivery in Ocular Oncology, working with Preclinical, Regulatory Affairs, Quality, Clinical Operations and other relevant departments and functions.
• 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.
• Define disease area strategies and R&D and potential partnership priorities.
• Accountable for ethical conduct of studies in the Ocular Oncology therapeutic area.
• Operate as a single point of contact for medical governance at the Ocular Oncology level.
• Be responsible for 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.
• Interface with preclinical research and development leadership in the evaluation and analysis of product opportunities
• Responsible for championing 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 show the primary goals of Clinical Development.
• Lead team of empowered and motivated clinical staff, drive the vision and align the team to achieve success in developing assets in the therapeutic area.
• Support 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 Certified in Ophthalmology required.
• 10 Years of R&D experience in Ophthalmology and/or oncology
• Proven line management skills, with at least 5 years of managing teams directly or indirectly.
• 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, want to ‘own’ Clinical Development and have a ‘role 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.