- Collaborating on, or leading where appropriate, the preparation of clinical trial related documents including protocols, Investigator Brochure updates, charters, result presentations, and clinical sections of regulatory documents.
- Reviewing safety and efficacy data, data listings and preparing/ supporting data presentations.
- Rapid response to data or results questions from senior management.
- Participate in trial level activities for multiple trials including review of Clinical Operations documentation such as operational plans, data management plans, etc.
- Support safety/PV related activities including working with safety management vendor for safety monitoring and reporting activities.
- Support activities related to training of internal team, vendors, and site staff as required.
- Conduct literature reviews and contribute to competitive assessments for each therapeutic area.
- Collaborate on projects as necessary with other functions within Clinical as well as across project teams (Regulatory, Medical Writing, Medical Affairs, etc.).
- Proven ability to effectively support/contribute to multiple complex studies or projects.
- Effective written and spoken communication is essential.
- Adhere to SOPs, systems, and other process related training.
Skills and Experience - Bachelor's degree in life sciences field is required; advanced degree (MS/PhD/PharmD, MD, etc.) is strongly preferred.
- Minimum of 5 years relevant Pharma or Biotech clinical drug development experience (PhI-IV) in a Clinical Scientist role. Urology clinical development experience strongly preferred, Oncology required.
- Experience in development of clinical documents to support regulatory submissions (eg, IND), clinical protocol/IB development, medical writing, literature reviews, data reviews and other similar clinical development projects.
- Knowledge of and experience applying the principles of clinical research methodology, statistics, data analysis and interpretation
- Proficiency in data review tools for data interpretation to both design/execute clinical trials and to extract data/prepare results for relevant clinical trials.
- Demonstrated evidence of writing clinical documents.
- Experience working with and managing third party vendors, such as CRO's
- Effective written and spoken communication skills are essential.
- Knowledge of FDA regulatory guidelines, drug development process and ICH/GCP is required.
- Knowledge of device global regulatory requirements such as 21 CFR 820, 21 CFR 4, 21 CFR 3.2, and ISO 13485 preferred.
- Strong project management skills and drive for excellence.
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Assoc. Director/Director, Clinical Development Scientist-Urologic Oncology - Brighton, United States - Aura Biosciences
Description
Job DescriptionJob DescriptionSalary: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.
Position Summary:
Aura Biosciences, Inc. is currently expanding its Clinical Development team to support several early- and late-phase clinical assets and is searching for a highly motivated and hands-on Associate Director/Director level Clinical Development Scientist to support the continued development of AU-011 in the treatment of ocular and non-ocular cancers. Aura is developing AU-011 as a biologic/drug-led combination product. This individual will be responsible for supporting the Medical Directors within the Clinical Development function, who are responsible for strategy, design, and oversight of all clinical programs at Aura.
Essential Functions and Duties:
