Senior Director/Executive Director, Preclinical Research and Development
3 weeks ago
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.
Role & Responsibilities:
The Sr./Exec. Director will perform various duties in support of preclinical development including helping to set the strategic direction for several preclinical programs tracking towards INDs, providing scientific input regarding needed preclinical studies, generating and executing on a plan to deliver preclinical data that supports INDs and First in Human Trials, representing the company in research meetings and developing and maintaining key scientific relationships in the field, including preclinical CROs and academic laboratories.
Essential functions:
* In partnership with senior management, provide the overall strategic preclinical direction and scientific leadership for several preclinical development-programs.
* Responsible for all areas of preclinical research and development, including generating pharmacology and toxicology data, preclinical trial strategy and design, preparation of the preclinical development plan to support successful INDs, and contribution to regulatory strategy.
* Lead the evaluation and selection of preclinical vendors and consultants that are best positioned to support Aura R&D goals.
* Demonstrated ability to design preclinical studies and, with outsourcing partners, drive on time execution within planned budgets.
* Lead scientific affairs activities, including preclinical information and establishing relationships with key KOLs.
* Obtain key stakeholder review and endorsement of science and preclinical aspects of all development programs.
* Stay current with GLP and regulatory requirements to support preclinical submission regulatory submissions including INDs.
* Interface with clinical development leadership to ensure preclinical activities are aligned with long term project goals.
* Develop clear preclinical trial strategies, design and write non-GLP and GLP study protocols, monitor, document, and interpret clinical study data.
* Responsible for preparation of preclinical sections of regulatory documents (INDs, IBs, etc.) and study reports; contribute to the preparation and conduct of meetings with FDA/EMA.
* Interface with Business Development and Finance to provide subject matter expertise on all preclinical strategic initiatives, including competitive and complementary products, technologies and companies.
Qualifications:
* Ph.D. in scientific discipline with preclinical experience in ophthalmology and/or oncology preferable.
* 10 years or more of full time industry experience in preclinical development preferred with a minimum experience of 5 years required; direct experience managing, planning organizing, implementing, and completing phase I-III clinical trials.
* This person will 'own' preclinical development and have a 'role up your sleeves and get it done' approach that is critical in biotech.
* Direct experience in toxicology and clinical pharmacology preferred.
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