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Clinical Research Scientist

2 months ago

Markham, Ontario, Canada Astellas Full time

Clinical Scientist

Are you interested in contributing to a diverse team dedicated to pioneering therapies for patients? At Astellas, we are committed to creating and delivering innovative and effective medications for healthcare providers and patients alike.

Astellas Pharma Inc. operates in over 70 countries globally, focusing on transforming innovative research into medical solutions that provide value and hope to patients and their families. Our commitment to addressing unmet medical needs while conducting our business with integrity and ethics allows us to enhance the health of individuals worldwide. For further details about Astellas, please visit our official website.

This role is available for remote work within Canada. We encourage candidates interested in remote opportunities to consider applying.

Role Overview:

The primary objective of the Clinical Scientist is to engage in the formulation of clinical strategies for designated modalities or indications within the organization. This position collaborates closely with the Global Medical Lead (GML), Operations Lead, Asset Lead, and Medical Monitor, and is responsible for the design, execution, oversight, and evaluation of clinical studies within the assigned program. Clinical Scientists are expected to operate independently and possess a solid understanding of clinical development to enhance their involvement in division and portfolio initiatives.

Key Responsibilities:

  • Accountable for all activities associated with current and upcoming clinical trials, including the development of protocols, investigator brochures, case report forms (CRFs), informed consent documents, and clinical study reports, as well as reviewing clinical trial documentation, study analyses, and reporting.
  • Provide expertise to cross-functional team members to synthesize and contextualize data, facilitating discussions and timely decision-making.
  • Participate in the clinical sub-team alongside the GML, Operations Lead, and Medical Monitor/Study Physician, supporting the preparation of clinical development plans, site identification, management, and DESC meetings.
  • Under the guidance of the study physician/medical lead, conduct medical monitoring activities, including reviewing, analyzing, and triaging patient data, and generating reports.
  • Independently lead working groups and/or sub-team initiatives in support of protocols, disease areas, or clinical development plans.
  • Collaborate with the GML in preparing for Health Authority (HA) meetings and assist in addressing inquiries from health authorities.
  • In conjunction with the GML and Product Responsible Person, prepare analyses for DMC/DSMB/DEC forums or regulatory submissions.
  • Deliver training at investigator meetings and site initiation visits, collaborating with Clinical Operations and Medical Affairs to ensure appropriate enrollment in clinical studies or registries. Work cross-functionally to create, review, and present clinical slides for internal meetings and external forums.
  • Support engagement with potential and current sites through activities such as site initiation visits, investigator meetings, conferences, steering committee, and advisory board meetings.
  • Involvement in early and/or late-phase studies.
  • Demonstrate expertise in Study Data Review and Analysis.
  • Provide clinical input into statistical planning, data analysis, and interpretation.
  • Offer clinical leadership and support for the publication of data, including manuscripts, presentations, and scientific publications related to diseases or technologies.
  • Collaborate closely with the operations group for site and vendor feasibility, trial setup, and monitoring.
  • May lead the execution of contracts, particularly for investigator meetings and advisory sessions.
  • Support efforts to establish strategic partnerships with Key External Experts (KEEs).
  • Act as a key partner for the Development Division in evaluating candidates within discovery, identifying opportunities and potential risks associated with future development strategies based on modality, indication, unmet need, competitive landscape, and clinical characteristics.
  • May represent development and assist with clinical assessments for due diligence of new assets for potential in-licensing and acquisition.
  • Support strategic initiatives related to assigned molecules, clinical development plans, therapeutic areas, or portfolios as needed.
  • Perform additional duties as assigned or participate in special projects as required.

Organizational Context:

  • This position reports to the Primary Focus Medical Head (or other Leads depending on grade) for the designated program.
  • This role is typically an individual contributor position, but may have direct reports based on the scope, responsibilities, and complexity of assigned development programs. If the position includes direct reports, it will align with Astellas guidelines for span of control and organizational levels.