Development Physician, Immuno-Oncology

Astellas Pharma Inc.; Markham; On-site; CAD 120,000 - 180,000; Full time

Job summary

A leading pharmaceutical company is seeking a Medical Monitor to oversee safety monitoring and coordinate clinical development for oncology trials. The successful candidate will be responsible for ensuring patient safety and leading clinical teams while managing complex trials. This role requires a strong background in clinical trial design and execution, alongside excellent communication skills and the ability to work within diverse teams. Competitive compensation and a comprehensive benefits package are offered, including medical, dental, and vision insurance.

Benefits

Medical, dental, and vision insurance

Paid time off

RRSP and annual bonus

Qualifications

• 5+ years of industry experience in clinical trials within biopharmaceuticals.
• Experience as a medical monitor and managing trial execution.
• High scientific integrity and work ethics.

Responsibilities

• Responsible for safety monitoring and clinical trial scope.
• Manage development of protocols and regulatory documents.
• Lead clinical development strategy and execution.

Skills

Communication

Clinical trial design

Clinical operations management

Education

MD or MD/PhD with oncology fellowship

Job description

Collaborates effectively with key internal and external stakeholders as a member of the asset team and leader of the clinical study team to advance one or more clinical trials.

Serves as Medical Monitor with responsibility for safety monitoring. Ensures patient safety on clinical studies by generating safety-related documents such as medical monitoring reports and maintaining the safety database to ensure that SAE reporting is current and complete. Collaborates closely with safety officers in writing and reviewing safety narratives, investigator letters, and other safety documentation for site-reported safety events.

Coordinates with safety officers on benefit-risk assessments, planning FIH study dose selection and escalation paths for early-phase programs, providing clinical input on clinical documents, statistical analysis plans, interim and final analyses, publications, CSRs, DSURs, and other critical documents.

Able to assimilate research, clinical pharmacology, biomarkers, medical safety, toxicology (early phase programs), regulatory, biostatistics, medical affairs, health economics, and commercial perspectives into clinical development strategies and trial designs.

Responsible for managing the development of protocols and regulatory documents.

Accountable for the development, implementation, and execution of clinical trials within large, complex late-phase (post POC, established market) programs or a group of earlier-stage programs, aligned with asset and overall clinical strategy.

In late-phase programs, serves as the lead for an indication-specific clinical development team, responsible for strategy and execution of the clinical development plan for that indication or line of therapy.

In earlier phases, serves as the clinical lead for the entire clinical development strategy and execution of a given program.

Gathers public knowledge regarding the therapeutic landscape, potential competitors, and serves as the clinical voice on the potential impact on planned clinical, medical affairs, and commercial strategies.

Creates and maintains scientific and clinical networks, seeking external opinion leaders as appropriate. Acts as the clinical interface during advisory boards, investigator meetings, and interactions with opinion leaders.

Serves as the clinical interface in regulatory authority interactions.

Responsible for clinical development milestones, supporting the medical lead and asset team at governance meetings, and presenting the clinical development plan clearly and succinctly.

Works with development scientists and clinical operations leads to ensure efficient trial execution and high-quality data collection to inform decision-making and strategies.

Designs scientifically rigorous, cost-effective, and patient-centric clinical trials according to the clinical development plan. Responsible for clinical trial scope, protocol, IB, ICF, in collaboration with relevant teams.

Keeps medical lead, asset lead, and development head informed about trial progress, risks, mitigations, and timeline or budget changes.

Supports clinical development initiatives and provides scientific and medical training to team members, investigators, and site staff as needed.

Quantitative Dimensions:

• Collaborates with clinical operations to select and oversee vendors within budget.
• Accountable for trial budgets and timelines, advising on scientific, technical, and regulatory factors affecting development timelines.
• Contributes to clinical program budgets in collaboration with medical and asset leads.

Organizational Context:

• Reports to the medical lead on the program.
• No direct reports.

Requirements

Qualifications: Required

• MD or MD/PhD with completed oncology fellowship. Board certification and patient treatment experience preferred.
• At least 5 years of industry experience in clinical trial design and execution within a biopharmaceutical setting or a combination of academia and industry.
• Proven record of designing high-quality, timely clinical trials for decision-making.
• Experience as a medical monitor and managing trial execution with clinical operations.
• Excellent communication skills in English.
• Experience working in global, remote, and multicultural teams.
• High scientific integrity and work ethics.

Preferred

• Extensive experience in gastroesophageal, thoracic oncology, or immuno-oncology in solid tumors.
• Experience in academic research and all phases of clinical development, including regulatory submissions.

Benefits:

• Medical, dental, and vision insurance.
• Paid time off, holidays, and breaks.
• RRSP, annual bonus, quarterly incentives, and long-term incentives for eligible roles.