Clinical Development Scientist, Rare Disease/Neurology

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.

Purpose and Scope:

The primary purpose of the Development Scientist will lead in the development of integrated clinical strategies for assigned translating scientific, clinical, regulatory, and competitive insights into actionable development plans and recommendations for governance. This position will work closely with the Global Medical Lead, Clinical Operations Lead, Asset Lead, and Medical Monitor, 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.

Responsibilities and Accountabilities:

Provides strategic clinical and scientific leadership across multiple studies and/or development programs, ensuring consistency of clinical strategy, study design, endpoints, data interpretation, and evidence generation across the development lifecycle.

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 or co-leads the clinical sub-team with Medical Lead, Clinical Operations Lead, or Medical Monitor/Study Physician and supports preparation of clinical development plans, site identification and management, and Dose Escalation meetings.

Represents Clinical Development at program level teams or governance forums, presenting clinical strategy, key risks, development options, and recommendations and ensuring alignment of resulting decisions with the clinical development plan.

Under the guidance of study physician/med lead, perform medical monitoring activities (review, analyze and triage patient data, generating reports)

Able to independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.

Provides clinical leadership for major Health Authority interactions, including development of clinical regulatory strategy, preparation of briefing materials and responses, participation in Health Authority meetings, and translation of regulatory feedback into clinical development strategy.

Together with the Medical Lead and Product Responsible Person may prepare analysis for DMC/DSMB/Dose Escalation Committee 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 enrolment 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).

Early and/or late phase studies

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.

Develops and maintains strategic relationships with leading external experts, investigators, patient/community stakeholders, and scientific collaborators to inform clinical strategy, study design, disease understanding, and evidence-generation plans.

Serve as key partner within Development Division in assessment of candidates within discovery, identifying opportunities and potential risks with future development strategies based on modality, indication, unmet need, competitive landscape and clinical characteristics.

May represent development and assist with clinical assessment for due diligence(s) of new assets for potential in-licensing and acquisition.

Identifies and leads therapeutic-area or Development Division initiatives that improve clinical development strategy, scientific quality, decision-making, or operational effectiveness beyond assigned programs.

Performs other duties as assigned or special projects as needed.