Associate Medical Director - USA

Aspyrian Therapeutics, Inc - United States (30+ days ago)


Company
Profile

We
are Rakuten Aspyrian Inc., a privately funded, clinical stage, Biotechnology
Company headquartered in San Diego, California. We are focused on advancing
innovative science into breakthrough products that provide cancer patients with
new treatments to conquer their disease.
We
are supported by investors that have the commitment to build a long-term
company that integrates research, development and commercialization of cutting
edge cancer therapies with the aim to transform cancer treatments. Our mission is
“CONQUERING Cancer. For LIFE.”

We
are developing therapies based on a novel proprietary technology platform that
utilizes antibodies conjugated with payloads that are specifically activated at
the tumor site. Our first clinical product will advance into Phase 3 pivotal
clinical testing to treat terminal cancer patients. This is a first-in-class
product with unique pharmacological activity and with the potential to have a
broad impact in cancer. 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
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 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 MD, DO, or
equivalent degree, hold an active MD &/or DO license, and have experience
in medical, surgical, or radiation oncology. Additionally, a working knowledge of drug development process, GCP, ICH
guidelines and FDA 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
the USA 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 MD, DO, or equivalent degree with active medical
license Oncology experience required, preferably in medical,
surgical &/or radiation Expertise in clinical trial design in oncology Working knowledge of FDA guidelines for adverse
event reporting, Federal Guidelines, GCP, and ICH-GCP Familiar with FDA guidelines for IND and NDA
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 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.

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.