Clinical Development Physician, Late Stage Oncology
About The Position
Astellas is seeking Development Physicians/Medical Directors to join its late-stage oncology clinical teams as its portfolio expands. The 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 role contributes to medical aspects of study documents and works with Development Scientists and Clinical Operation Leads to support efficient trial execution, high-quality clinical data, program decisions, and development strategies. It also supports clinical development initiatives and provides scientific and medical training to team members and external stakeholders. This global role is based in Northbrook, Illinois, with remote work from anywhere in the US available and a hybrid working solution described by Astellas. It involves cross-regional coordination and collaboration across EU, US, and Japan time zones, with frequent interaction with senior leadership and governance bodies. 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 collectively responsible for the design and execution of one or more clinical trials.
- Serve as Medical Monitor and monitor safety in 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 enable efficient trial execution and acquisition and interpretation of high-quality clinical data for program-level decision-making and development strategies.
- Support functional-level clinical development initiatives as needed.
- Lead and/or participate in scientific and medical training for team members, external clients, investigators, and other site staff as it relates to assigned studies.
- Coordinate across regions and collaborate with international stakeholders and disciplines.
Benefits
- Medical, dental, and vision insurance.
- Generous paid time off, 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
