Purpose and Scope:Due to the expanding portfolio, we are looking for Development Physicians/Medical Directors to join our clinical teams in late development Oncology at Astellas.
Responsibilities and Accountabilities:- Core member of the clinical team which is collectively responsible for the design and execution of one or more clinical trials.
- Serves as Medical Monitor with responsibility for safety monitoring on clinical studies. Generates safety related documents, such as medical monitoring reports . Collaborates closely with the safety officer in writing and/or reviewing safety narratives, investigator letters, and other safety documentation for site-reported safety events.
- With the Development Scientist, responsible for the medical aspects of all study-related documents, including for example the clinical study protocol, informed consent forms, clinical database, safety committee charters and clinical study reports.
- Works with Development Scientists and Clinical Operation Leads to ensure efficient and streamlined execution of clinical trials and acquisition and interpretation of high-quality clinical data to inform program-level decision making and overall development strategies.
- Supports functional level clinical development related initiatives as needed. Leads and/or participates in scientific and medical training to other team members and external clients, investigators, and other site staff as it pertains to assigned studies.
- Reports to the Global Medical Portfolio Lead for Late Oncology.
Required Qualifications:- MD or MD/PhD
- Must have 2+ years experience specifically in oncology clinical trial design and execution in a bio-pharmaceutical 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.
- Aware of cultural diversity and how to influence and manage in a multi-cultural organization.
- Highest level of scientific integrity and impeccable work ethics
Preferred Qualifications:- Board certified in Oncology or Oncology-related specialty
- Experience in solid tumors, preferably Gastro-Intestinal, Thoracic or Genito-Urinary
- Experience in late development oncology (Ph3)
- Direct experience leading global regulatory marketing authorization submissions and defense of those submissions
Location and Working EnvironmentThis position is based in Northbrook, IL. Remote work from anywhere in the US is available.
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
This position is a global role with strong interaction with various disciplines and international stakeholders
- Highly matrixed environment requiring cross-regional coordination.
- Frequent interaction with senior leadership and governance bodies.
- Collaboration across EU, US, and Japan time zones.
Salary Range$207,192 - $295,988 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
*The salary range provided applies to US only and does not apply to any other locations outside of the US
Benefits:- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
- 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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