Rakuten Aspyrian is building its Medical team to support its ongoing and upcoming clinical studies, including a global Phase III clinical study. The Associate Medical Director will be a key member of the Clinical Operations team with responsibilities to support Rakuten Aspyrian’s current clinical development program, provide medical consultation to company and project team members for clinical activities, and participate in new product development.
The ideal candidate will have an M.D., D.O. or equivalent degree, hold an active M.D. or D.O. license, and have experience in medical, surgical, or radiation oncology. Additionally, a working knowledge of drug development process, GCP, ICH guidelines and EMA regulations as well as direct involvement as an investigator of clinical studies or direct experience in managing clinical operations is highly desirable.
The Associate Medical Director may be located anywhere in Western Europe within a reasonable distance of a major airport, and will report to the Global Medical Director.
Key Duties and Responsibilities
- Teach and observe investigators performing Aspyrian therapies
- Provide medical oversight of clinical trials to ensure company Standard Operating Procedures, company directives and regulatory requirements are understood and followed
- Perform medical review of clinical study reports
- Attend and present at investigator and company meetings as needed and requested
- Provide medical consultation to company and project team members regarding clinical trial activities
- Participate in clinical trial development, including providing input into and/or developing materials such as target product profiles, protocols/amendments and informed consents
- Active participation in discussions with regulatory agencies
- Participate in new product development activities
- Manage integration of clinical programs with regulatory strategy
- Participate in clinical sites identification, clinical sites initiation, close-out processes and oversight of clinical sites
- Participate in management of CROs handling clinical studies
- Manage interactions with KOLs, etc.
- Other duties as assigned
Desired Education, Skills and Experience
- An M.D., D.O. or equivalent degree with active medical license
- Oncology experience required, preferably in medical, surgical and/or radiation
- Expertise in clinical trial design in oncology
- Working knowledge of EMA guidelines for adverse event reporting, Federal Guidelines, GCP, and ICH-GCP
- Familiar with EMA guidelines for Clinical Trial Authorization and other regulatory submissions
- Understanding of clinical pharmacology with an emphasis on PK/PD of antibodies
- Working knowledge of biostatistics, data management, and clinical operations’ procedures
- Proficient in the drug development process
- Strong analytical skills
- Excellent oral and written communication skills in English
- Outstanding interpersonal and team building skills
- Ability to work independently, analyse, and work with attention to detail, process and prioritize sensitive complex information and problem solve
- Ability to exercise creativity and judgment
- Able to travel approximately 50% of the time (including overnight stays) by air, rail, or auto to clinical sites to support European clinical studies.
Location: Western Europe, Western Europe
Min. Experience: Senior Level