Rakuten Aspyrian is building its Medical team to support its ongoing and upcoming clinical studies, including a global Phase 3 clinical study. The Senior Medical Director, Medical Director or Associate Medical Director will be a key member of the Medical team with responsibilities to support Aspyrian’s current clinical development program, provide medical expertise to company and project team members, participate as a project team member in new product development and be the medical lead in Phase 1 and Phase 2 trials commensurate with their experience.
The ideal candidate will have an MD, DO, or equivalent degree, hold an active MD &/or DO license, with experience in medical, surgical, or radiation oncology preferred. Additionally, previous industry experience including a working knowledge of drug development process, GCP, ICH guidelines, FDA and EMA regulations as well as direct involvement as an investigator of clinical studies or direct experience in managing clinical operations, medical affairs, and medical safety and monitoring is highly desirable.
The Medical Director may be located anywhere in the USA within a reasonable distance of a major airport, and will report to the Chief Medical Officer.
Key Duties and Responsibilities
- Instruct and oversee investigator’s proper performance of Rakuten Aspyrian therapies
- Provide medical oversight of clinical trials to ensure company standard operating procedures, company directives and regulatory requirements are understood and followed
- Provide medical expertise to identify new product opportunities and portfolio development
- Active participation as a member of the clinical development team for early stage products
- Medical lead for Phase 1 and Phase 2 clinical trials
- Participate in clinical trial development, including providing input into and/or developing materials such as target product profiles, protocols/amendments and informed consents
- Work with the Medical Safety and Pharmacovigilance team to perform clinical site medical monitoring as necessary
- Perform medical review of clinical study reports
- Attend and present at investigator and company meetings as needed in collaboration with Medical Affairs
- Manage integration of clinical programs with regulatory strategy
- Participate in clinical site identification, initiation oversight, and close-out
- Support the clinical operations group in the management of the CRO’s timely execution of clinical studies
- Actively participate in interactions with KOLS, in coordination with Medical Affairs
- Other duties as assigned
Desired Education, Skills and Experience
- An MD, DO, or equivalent degree with active medical license required
- Oncology experience required, preferably in medical, surgical &/or radiation oncology
- Expertise in clinical trial design in oncology preferred
- Experience in Medical Affairs, Medical Safety, Medical Monitoring and Medical lead on Phase 1-2 clinical trials highly valued.
- Working knowledge of FDA & EMA guidelines for adverse event reporting, Federal Guidelines, GCP, and ICH-GCP
- Familiar with FDA & EMA guidelines for IND and NDA submissions
- Understanding of clinical pharmacology with an emphasis on PK/PD of antibodies preferred
- 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
- 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 US clinical studies.
Location: Regional USA
Department: Clinical Development