Clinical Development Physician, Oncology (Senior Medical Director)
About The Position
Due to the expanding portfolio, we are looking for Medical Directors to join our clinical teams in late development oncology at Astellas. Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Requirements
- MD or MD/PhD
- Must have 5+ 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
Nice To Haves
- 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
Responsibilities
- 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.
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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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
