Company Profile

Rakuten Aspyrian, Inc., is a privately funded clinical stage biotechnology company with offices in the USA, Japan and Germany. Since 2013, Rakuten Aspyrian has been developing new anticancer therapies based on the Photoimmunotherapy platform. Rakuten Aspyrian plans to become a fully integrated biopharma with research, development, and world-wide commercialization of therapies based on the Photoimmunotherapy platform.

Our long-term objective is to commercialize a number of therapies based on Photoimmunotherapy to treat a broad range of solid tumor types as single agent and in combination with other immunomodulatory agents to generate robust and long lasting anticancer immunological responses.

Rakuten Aspyrian is currently sponsoring a global Phase 3 multicenter clinical study for ASP-1929 to evaluate the efficacy and safety of ASP-1929 in patients with recurrent Head and Neck Cancer and additional Phase 2 studies to evaluate the safety and efficacy of ASP-1929 in patients with other cancer types.

Given the rapid progression of the clinical studies we are quickly expanding the team to support late stage pivotal clinical development and future commercialization of our products.

Position Summary

The Global Medical Director Oncology will provide medical leadership and support to oversee and be responsible for the safe and effective clinical application of Aspyrian’s products in clinical trials as well as approved products. This role will provide clinical expertise and insights to help shape and form the overall development strategy for Aspyrian’s oncology portfolio. The Global Medical Director will report to the Chief Medical Officer and will lead and be responsible for clinical site selection, medical oversight of the study including safety, and overseeing the Medical Directors and Field Clinical Trainers.

Key Duties and Responsibilities

• Provides medical oversight and is responsible for the safe and appropriate clinical application of Aspyrian’s products in clinical trials and post marketing.

• In cooperation with affiliate medical departments, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects

• Initiates medical activities and generation of data and information supporting the safe and appropriate use of Aspyrian’s products by clinicians.

• Responsible for medical safety in clinical trials by ensuring the appropriate use and application of Aspyrian’s products by clinicians as well as working with the safety and pharmacovigilance team

• Ensure that all company clinical trials are conducted according to GCP and all applicable regulatory requirements, with a focus on the safety and medical monitoring aspects of the trials;

• Provide scientific/medical education to the Medical Directors and Clinical Trainers related to the safe and appropriate application of the Aspyrian therapy in each therapeutic area or disease specific application.

• Along with the Medical Directors and Clinical Trainers, provide scientific/medical education to the investigators, clinical site medical teams, research nurses and clinical monitor team members regarding the safe and appropriate application of the Aspyrian therapy in each therapeutic area or disease specific application.

• Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements.

• Serves as the medical team interface for key regulatory and Medical Affairs discussions.

• May act as medical leader for projects within an area or across several areas.

• May assist in the development of medically accurate marketing materials, medical education programs, advisories, and symposia.

• Perform, as needed, research and analytics and provide recommendations to support quality medical decisions regarding clinical research, consultancy, and internal planning.

• Represent company at professional meetings, congresses, and local symposia.

• Develop effective working relationships with key investigators in oncology area to optimize scientific quality/ innovation of clinical study design, execution, reporting, and publication

• Oversee Medical Directors and Field Clinical Trainers for proper execution of clinical trials

• Involved in clinical trial design development

• Other duties as assigned

Desired Education, Skills and Experience

• Advanced education (e.g., MD or DO) required.

• 10 yrs experience in the pharmaceutical industry or equivalent; substantial understanding of oncology therapeutic area required.

• Management and leadership experience at program level as well as experience with strategic initiatives/issues.

• Proven leadership skills in a global and cross-functional team environment. International experiences a plus.

• Ability to interact externally and internally to support global business strategy.

• Ability to run a clinical study and medical therapeutic team with little supervision.

• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, medical trial safety and experience in development strategy and the design of protocols.

• Excellent organizational skills and ability to meet deadlines

• Exceptional self-management ability

• Regular travel required (approx. 40%)

We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.

Rakuten Aspyrian Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.