Associate Director, Clinical Development, Gene Therapy

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at [Register to View]

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

The Role

The Associate Director, Clinical Development will provide clinical leadership on a gene therapy program (role may extend to other gene therapy programs over time). Working closely with the global medical lead, the Director supports the design, implementation, monitoring, analysis, and reporting of clinical studies conducted within the program. In addition, they will collaborate with the cross functional team to develop long-range strategic plans for the program and execute upon these plans. The current focus of drug development is in the development and commercialization of highly innovative gene therapy technology in diseases where there is unmet medical need and for children and adults with serious, rare genetic diseases.

Primary Responsibilities

• Work together with the global medical lead to support clinical development activities including preparation of regulatory submissions for the target clinical program.
• Support activities related to all current and planned clinical trials (e.g., develop protocols, investigator brochures, and clinical study reports and review clinical trial documents, CRO management, clinical support of regulatory interaction, and study analysis and reporting).
• Partner with Research, Regulatory Affairs, Non-Clinical Science, and Medical Affairs to ensure timely and effective clinical and scientific input into overall program.
• Support and/or lead investigator meetings and lead site initiation visits with clinical trial investigators, and partner with Clinical Operations and Medical Affairs in driving enrollment into the clinical studies or registries
• Represent the company at scientific meetings, patient advocacy events and other public relations opportunities
• Study Data Review and Analysis
  • Provide clinical input into statistical planning, data analysis and interpretation
  • Perform ongoing review and analysis of study data
  • Provide clinical leadership and support for publication of data (manuscripts, posters, etc.) and disease or technology related scientific publications
• Support efforts to develop strategic partnerships with Key Opinion Leaders
• Together with the Global Medical Lead monitor safety and prepare safety related analysis for DMC forums or regulatory submissions