ModeX Therapeutics, an OPKO Health subsidiary, is a clinical-stage biopharmaceutical company developing next-generation multispecific antibodies and vaccines for cancer and infectious disease. ModeX's modular antibody platforms unite the power of multiple biologic components in a single molecule to create multispecific antibodies with greater versatility and potency to fight complex disease than traditional approaches. Our pipeline includes candidates against both solid and hematological tumors as well as several of the world's most pressing viral threats. Our founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients.

The Medical Director will be a key member of program and clinical development teams and will play a pivotal role in driving the collaborative development and execution of clinical strategies for our immune-oncology programs. 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 excellent medical judgement, communication, collaboration and leadership skills, and an awareness of business principles and cultural awareness.

Key Responsibilities

• Medical monitoring: Provide medical oversight for ongoing clinical trials, including safety monitoring, data analysis, and interpretation of clinical trial results. Collaborate with study team to prepare, review and complete clinical study and safety documentation.
• Clinical strategy: Contribute to the development and execution of comprehensive clinical development plans for immune-oncology programs. Provide feedback on clinical study data, reports, protocols, and development plans. Collaborate with early development research teams on clinical aspects and disease indications.
• Clinical trial design: Contribute to the design and oversight of clinical trials, develop study protocols, review operational documents (eg case report forms, monitoring manuals, informed consent documents) as well as ensuring the trials are conducted in compliance with regulatory standards and ethical guidelines.
• Health authority engagement: Collaborate with the regulatory team to prepare and submit regulatory documents to health authorities, including INDs, NDAs, and BLAs.
• Key opinion leader engagement: Build and maintain strong relationships with key opinion leaders 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 and execution on program objectives.

• Communications and publications: Present clinical trial study and patient updates as appropriate to internal and external stakeholders. Contribute towards the development of scientific publications, presentations, and educational materials.

Qualifications

• Medical degree (MD) with at least 5 years of drug development experience in the pharmaceutical or biotechnology environment.
• Experience in oncology drug development including the development of biologics is required. Experience in infectious disease drug development is a bonus.

• Knowledge of regulatory requirements and experience interacting with regulatory agencies.
• As a subject matter expert, contribute effectively and independently, and as part of a cross-functional team.
• Excellent verbal and written communication skills.
• Strong analytical and problem-solving abilities.
• A track record of successful clinical trial design and execution.
• Exceptional leadership and interpersonal skills.

Preferred Qualifications

• Board certification in the United States; hematology-oncology preferred.
• Experience in translational medicine and biomarker development.

ModeX Therapeutics is an Equal Opportunity Employer