Clinical Research Scientist

4 weeks ago

Markham, Ontario, Canada Astellas Pharma Inc. Full time
Key Responsibilities:
  • Accountable for overseeing all aspects of ongoing and upcoming clinical trials, including the formulation of protocols, investigator brochures, case report forms (CRFs), informed consent documents, and clinical study reports, as well as reviewing trial documents and study analyses.
  • Provide specialized knowledge to multidisciplinary team members to integrate and contextualize data, promoting effective discussions and timely decision-making.
  • Collaborate within the clinical sub-team alongside the Global Medical Lead, Operations Lead, and Medical Monitor to assist in the preparation of clinical development strategies, site selection, and management, as well as DESC meetings.
  • Under the mentorship of the study physician or medical lead, conduct medical monitoring tasks, including the review and analysis of patient data and report generation.
  • Demonstrate the ability to independently lead working groups or sub-team initiatives in support of clinical protocols, disease areas, or development plans.
  • Partner with the Global Medical Lead in preparing for Health Authority meetings and addressing inquiries from health authorities.
  • Collaborate with the Global Medical Lead and Product Responsible Person to prepare analyses for Data Monitoring Committees, Data Safety Monitoring Boards, or regulatory submissions.
  • Deliver training during investigator meetings and site initiation visits, working closely with clinical trial staff and collaborating with Clinical Operations and Medical Affairs to ensure appropriate enrollment in clinical studies or registries.
  • Engage with potential and current study sites through site initiation visits, investigator meetings, conferences, steering committees, and advisory board meetings for both early and late-phase studies.
  • Exhibit expertise in Study Data Review and Analysis, providing clinical insights into statistical planning, data interpretation, and leading efforts for the publication of research findings.
  • Work in close coordination with the operations team for site and vendor feasibility assessments, trial setup, and monitoring activities.
  • May take the lead in executing contracts, particularly for investigator meetings and advisory sessions.
  • Support initiatives aimed at establishing strategic partnerships with Key External Experts.
  • Act as a crucial partner for the Development Division in evaluating candidates within discovery, identifying opportunities and potential risks associated with future development strategies.
  • May represent the development team and assist in clinical assessments for due diligence on new assets considered for in-licensing or acquisition.
  • Support strategic initiatives related to assigned molecules, clinical development plans, therapeutic areas, or portfolios as needed.
  • Perform additional duties or special projects as assigned.

Organizational Context:

  • This role reports to the Primary Focus Medical Head or other designated leads based on the program.
  • This position is primarily an individual contributor role, although it may include direct reports depending on the scope and complexity of assigned development programs.

Qualifications:

Required:

  • Advanced degree in a relevant scientific field, health science, or clinical discipline, typically with 7-10 years of experience in clinical, scientific research, pathology, or related industry experience.
  • Extensive knowledge and proven expertise in the biotechnology or pharmaceutical industry, particularly in clinical drug development from initial study design through to regulatory submissions.
  • Experience in scientific research or clinical practice, supported by appropriate qualifications and publications.
  • Proficient in computer applications, including the MS Office Suite and industry-standard software for data capture and analysis.
  • Strong interpersonal and communication skills, capable of engaging with various internal stakeholders and functional areas.
  • Demonstrated success in collaborating with key external stakeholders, including presenting to health authorities.
  • Knowledge of global pharmacovigilance standards and guidelines.
  • Ability to thrive in a dynamic and flexible work environment.
  • Excellent strategic planning, organizational, and communication skills.
  • Ability to exercise sound judgment and professionalism in all interactions.
  • Capacity to work independently with minimal oversight while maintaining high accuracy and attention to detail.
  • Willingness to travel approximately 25%, including potential international travel.

Preferred:

  • Doctorate or PharmD degree, or other relevant Master's degree.
  • Knowledge and proficiency in Medical Affairs activities, including registries.

Benefits:

  • Comprehensive Medical, Dental, and Vision Insurance.
  • Generous Paid Time Off, including vacation, sick leave, and national holidays.
  • Country-specific Retirement Savings Plan.
  • Company-paid life insurance.
  • Annual Corporate Bonus and Quarterly Sales Incentives for eligible roles.
  • Long-Term Incentive Plan for qualifying positions.
  • Referral bonus program.

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