Immatics US is currently seeking a Medical Director. The position is based in Houston, Texas.
The Medical Director oversees design, implementation and medical monitoring of multiple clinical studies. This position will develop strategies for long term clinical development programs, manage interactions with the Data Safety Monitoring committees and key personnel at clinical research sites.
The Medical Director will work in an interdisciplinary environment with colleagues from Clinical Operation, Clinical Development, Program Management and Regulatory Affairs and in close collaboration with the MD Anderson Cancer Center colleagues from various departments of Immatics Biotechnologies GmbH (Germany).
Essential Job Functions
- Manages the design and implementation of multiple clinical development programs in support of an overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements.
- Responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation and communication of accumulating data pertaining to safety and efficacy.
- Provides medical expertise needed to effectively and efficiently resolve complex and unique issues related to clinical trials.
- Assures all medical review activities conform to company protocol and professional standards.
- Work closely with other staff members to attain and/or maintain compliance and regulatory requirements.
- Ensure database planning and implementation.
- Adverse Event Reporting Monitoring.
- Develops and delivers key presentations, both internally and externally, to convey the clinical development perspective and provide updates on activities.
- Works with Regulatory and other stakeholders in the completion and submission of IND applications and filings.
- Works closely in the design and development of trial protocols.
- Develops the product safety profile.
- Develops key clinical sections of Investigator Brochures.
- Contributes to the safety and/or other relevant sections of IND annual reports.
- Establish professional working relationships with sites to support the development of the highest possible partnerships.
- Stays abreast of professional information and technology through conferences, medical literature to augment expertise in the therapeutic area.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Minimum Required Education, Experience & Skills
- Must have M.D. or D.O. degree with experience in Oncology Clinical Studies
- At least two years of experience with clinical trials, preferably in the pharmaceutical industry.
Please submit resume and cover letter to HR-US@immatics.com
Immatics US, based in Houston, Texas, is a highly innovative biopharmaceutical company developing adoptive cellular immunotherapies against novel cancer targets. For additional information about Immatics, please visit our website www.immatics.com.