The Medical Director will be a key member of Project and Clinical Development teams and will play a pivotal role in driving the development and execution of clinical strategies for our oncology and/or infectious disease programs. The Medical Director will contribute collaboratively toward the clinical aspects of research and early-stage development programs. This includes providing insight into treatment indications, patient populations, study designs and overall development strategies. The Medical Director will also play a critical role in clinical study medical monitoring and in collaborative relationship-building with trial investigators and key opinion leaders. This position requires an understanding of both therapeutic areas, excellent communication, collaboration and leadership skills, and an awareness of business principles and cultural awareness.
- Clinical Strategy: Contribute to the development and execution of comprehensive clinical development plans for oncology and infectious disease programs. Offer expert clinical advice, drawing on extensive clinical knowledge. Provide feedback on clinical study data, reports, protocols, and development plans. Collaborate with early development research teams on clinical aspects and disease indications.
- Scientific Leadership: Serve as the medical expert for the company in oncology and/or infectious disease, staying current with the latest research and medical advancements in these fields.
- Clinical Trial Design: Contribute to the design and oversight of clinical trials, develop study protocols, case report forms, and informed consent documents, ensuring they are conducted in compliance with regulatory standards and ethical guidelines.
- Regulatory Affairs: Collaborate with the regulatory team to prepare and submit regulatory documents to health authorities, including INDs, NDAs, and BLAs. Collaborate with study team to prepare and complete clinical study reports, investigator’s brochures.
- Medical Monitoring: Provide medical oversight for ongoing clinical trials, including safety monitoring, data analysis, and interpretation of clinical trial results.
- KOL Engagement: Build and maintain strong relationships with key opinion leaders (KOLs) and academic institutions to support the company's scientific and clinical objectives.
- Cross-Functional Collaboration: Collaborate closely with other departments such as research and development, clinical operations, and regulatory affairs to ensure alignment on program objectives.
- Publication and Communication: Lead the development of scientific publications, presentations, and educational materials related to oncology and infectious disease programs.
- Medical degree (MD) with 3 or more years of clinical research and/or drug development experience in pharmaceutical or CRO environment.
- Experience in oncology or infectious disease (or both) drug development
- Knowledge of regulatory requirements and experience interacting with regulatory agencies.
- Ability to contribute as a subject matter expert, work effectively in and mentor cross-functional teams.
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
- A track record of successful clinical trial design and execution.
- Exceptional leadership and interpersonal skills.
- Board certification (or eligibility) preferred in oncology or infectious disease.
- PhD in a relevant research area, or collaborative research work with bench scientists
- Experience in translational medicine and biomarker development.
About ModeX Therapeutics, Inc.
ModeX Therapeutics, a subsidiary of OPKO Health Company, is a biotech company based in Massachusetts dedicated to the concept of modulating multiple disease targets with an innovative multi-targeting approach. It was founded by Dr. Elias Zerhouni and Dr. Gary J. Nabel with a team of established and dedicated scientists in 2020 and is pursuing the development of novel immune-oncology therapeutics for cancers and infectious disease.
ModeX Therapeutics is an Equal Opportunity Employer