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Clinical Research Scientist

2 months ago

Markham, Ontario, Canada Astellas Pharma Inc. Full time
Key Responsibilities:
  • Accountable for overseeing all activities related to ongoing and upcoming clinical trials, including the development of protocols, investigator brochures, case report forms (CRFs), informed consent documents, and clinical study reports.
  • Provides specialized knowledge to cross-functional teams to integrate and contextualize data, facilitating discussions and timely decision-making.
  • Participates in the clinical sub-team alongside the Global Medical Lead, Operations Lead, and Medical Monitor, aiding in the preparation of clinical development strategies, site identification, and management.
  • Under the mentorship of the study physician or medical lead, conducts medical monitoring tasks, which include reviewing, analyzing, and triaging patient data, as well as generating reports.
  • Capable of independently leading working groups or sub-team initiatives in support of clinical protocols and development plans.
  • Collaborates with the Global Medical Lead in preparing for Health Authority meetings and addresses inquiries from regulatory bodies.
  • May assist in preparing analyses for Data Monitoring Committees or regulatory submissions in conjunction with the Global Medical Lead and Product Responsible Person.
  • Facilitates training sessions at investigator meetings and site initiation visits, partnering with Clinical Operations and Medical Affairs to ensure appropriate enrollment in clinical studies.
  • Engages with potential and current study sites through various activities such as site initiation visits, investigator meetings, and advisory board meetings.
  • Demonstrates expertise in Study Data Review and Analysis, providing clinical insights into statistical planning and data interpretation, and supporting the publication of findings.
  • Works closely with operational teams for site and vendor feasibility assessments, trial setup, and monitoring activities.
  • May lead contract execution, particularly for investigator meetings and advisory sessions.
  • Supports the development of strategic partnerships with Key External Experts (KEEs).
  • Acts as a key collaborator 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 for potential in-licensing and acquisition.
  • Contributes to strategic initiatives related to assigned molecules, clinical development plans, or therapeutic areas as needed.
  • Performs 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 programs.

Qualifications:

Required:

  • Advanced degree in a relevant scientific field, with 7-10 years of experience in clinical, scientific research, or industry-related roles.
  • In-depth knowledge and demonstrated expertise in the biotechnology or pharmaceutical industry, particularly in clinical drug development.
  • Experience in scientific research or clinical practice, evidenced by relevant qualifications and publications.
  • Proficient in Microsoft Office Suite and industry-standard software for data analysis.
  • Strong interpersonal skills, capable of engaging with various internal stakeholders across multiple functions.
  • Proven success in collaborating with external stakeholders, including health authorities.
  • Familiarity with global pharmacovigilance standards.
  • Ability to adapt in a dynamic and challenging work environment.
  • Excellent strategic planning and communication skills.
  • Demonstrated ability to work independently with a high level of accuracy and attention to detail.
  • Willingness to travel approximately 25%, including international travel.

Preferred:

  • PhD or PharmD degree, or other relevant advanced degree.
  • Knowledge of Medical Affairs activities, including registries.

Benefits:

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