Development Scientist

Description

Development Scientist (Director)

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com .

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

L ocation and Working Environment

This position is hybrid and will require you to be onsite 1 day per quarter at Bourne office in London, UK. The role is offered on a hybrid basis.

At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.

This role reports to the Global Medical Portfolio Lead, GU and Emerging Areas.

The Opportunity

As the Development Scientist you will join a diverse and agile team and contribute to the development of clinical strategies for assigned modalities or indications within the division.

The primary purpose of the Development Scientist will participate in the development of clinical strategies for assigned modalities or indications within the division. This position will work closely with the Global Medical Lead (GML), Operations Lead, and Development Physician, and is accountable for the design, implementation, monitoring, and analysis of clinical studies conducted within the assigned program. Development Scientists are expected to perform their responsibilities independently and have core knowledge of clinical development to enable increased participation in division and portfolio level initiatives.

At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Responsibilities

• Responsible and accountable for activities related to all current and planned clinical trials (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting) on assigned development programs.
• Provides expertise to cross-functional team members to synthesize/contextualize data to facilitate discussion and timely decision making.
• Serves on the clinical sub-team with the GML, Operations Lead, and Medical Monitor/Development Physician and supports preparation of clinical development plans, site identification and management, and DESC meetings.
• Under the guidance of development physician/GML, performs medical monitoring activities (Review, analyze and triage patient data, generating reports

Responsibilities Continued

• Able to independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.
• Partners with GML in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries.
• Together with the GML and Product Responsible Person may prepare analysis for DMC/DSMB/DEC forums or regulatory submissions.
• Provides training at investigator meetings and site initiation visits with clinical trial staff, and partners with Clinical Operations and Medical Affairs in enabling appropriate enrollment into the clinical studies or registries. Collaborates cross-functionally to create, review, and/or present clinical slides for internal meetings and external forums.
• Supports engagement with potential and current sites (e.g. SIVs, investigator meetings, conferences, steering committee, advisory board meetings).
• Exhibits expertise related to Study Data Review and Analysis:
• Provides clinical input into statistical planning, data analysis and interpretation
• Provides clinical leadership and support for publication of data (manuscripts, presentations) and disease or technology related scientific publications
• Works closely with operations group for site and vendor feasibility, trial set up and monitoring.
• May lead the execution of contracts, particularly for investigator meetings and advisories.
• Supports efforts to develop strategic partnerships with Key External Experts (KEEs)
• May represent development and assist with clinical assessment for due diligence(s) of new assets for potential in-licensing and acquisition.

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