Associate Medical Director
Associate Medical Director
Aspyrian Therapeutics Inc. is a privately funded, clinical-stage Biotech company. Our novel proprietary photoimmunotherapy technology uses antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product will initiate Phase 3 clinical testing this summer 2018 to treat recurrent HNSCC.
Aspyrian Therapeutics 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.
Aspyrian Therapeutics Inc. is EOE.