Clinical Development Physician, Late Stage Oncology

Astellas • Northbrook, IL

7d • Hybrid

About The Position

Astellas is seeking a Development Physician/Medical Director to join its late-development oncology clinical teams as its portfolio expands. This position is a core member of clinical teams responsible for designing and executing clinical trials and serves as Medical Monitor with responsibility for study safety monitoring. The physician works with Development Scientists, Clinical Operation Leads, safety officers, investigators, and other stakeholders to support high-quality trial execution, safety documentation, and program-level development decisions.

The role is based in Northbrook, Illinois, with remote work available from anywhere in the United States and a hybrid working solution that combines office and home work, subject to Astellas’ Responsible Flexibility Guidelines. It is a global role in a highly matrixed environment, with cross-regional coordination, frequent interaction with senior leadership and governance bodies, and collaboration across EU, US, and Japan time zones. The position reports to the Global Medical Portfolio Lead for Late Oncology.

Requirements

• MD or MD/PhD.
• At least 2 years of experience specifically in oncology clinical trial design and execution in a biopharmaceutical development organization, or a balance of experience at an academic institution and a pharmaceutical company.
• Excellent verbal and written communication skills in English.
• Experience working in global teams and a global, matrixed, remote working environment.
• Awareness of cultural diversity and the ability to influence and manage in a multicultural organization.
• Highest level of scientific integrity and impeccable work ethics.

Nice To Haves

• Board certification in Oncology or an oncology-related specialty.
• Experience in solid tumors, preferably gastrointestinal, thoracic, or genitourinary cancers.
• Experience in late-development oncology, including Phase 3.
• Direct experience leading global regulatory marketing authorization submissions and defending those submissions.

Responsibilities

• Serve as a core member of clinical teams responsible for the design and execution of one or more clinical trials.
• Serve as Medical Monitor and oversee safety monitoring for clinical studies.
• Generate safety-related documents, including medical monitoring reports.
• Collaborate with the safety officer to write and/or review safety narratives, investigator letters, and other safety documentation for site-reported safety events.
• With the Development Scientist, oversee the medical aspects of study-related documents, including clinical study protocols, informed consent forms, clinical databases, safety committee charters, and clinical study reports.
• Work with Development Scientists and Clinical Operation Leads to support efficient, streamlined trial execution and acquisition and interpretation of high-quality clinical data for program-level decisions and development strategies.
• Support functional-level clinical development initiatives as needed.
• Lead and/or participate in scientific and medical training for team members and external clients, investigators, and site staff in relation to assigned studies.

Benefits

• Medical, dental, and vision insurance.
• Generous paid time off options, including vacation and sick time, plus national holidays and year-end shutdown.
• 401(k) match and annual company contribution.
• Company-paid life insurance.
• Annual corporate bonus and quarterly sales incentive for eligible positions.
• Long-term incentive plan for eligible positions.
• Company fleet vehicle for eligible positions.
• Referral bonus program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree