- 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, as a key contributing member of cross-functional study teams.
- Effective written and spoken communication is essential.
- Adhere to SOPs, systems, and other process related training.
- Advanced degree (MS/PhD/PharmD, MD, etc.) is strongly preferred, bachelor's degree in life sciences field is required.
- Minimum of 5 years relevant Pharma or Biotech clinical drug development experience (PhI-IV) in a Clinical Scientist role. Ophthalmology and/or Oncology clinical development experience strongly preferred.
- 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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Director Clinical Development Scientist - Brighton, United States - Aura Biosciences Inc.
3 weeks ago
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, and 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.
Position Summary:
Aura Biosciences, Inc.
is currently expanding its Clinical Development team to support several early- and late-phase clinical programs and is searching for a highly motivated and hands-on (Sr) Director level Clinical Development Scientist to support the continued development of AU-011 in the treatment of ocular and non-ocular bladder 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.
This position reports to the SVP of Oncology Clinical Development.Essential Functions and Duties:
