Medical Director, Immuno-Oncology
We are a clinical-stage biopharmaceutical company developing next-generation multispecific antibodies and vaccines for cancer and infectious diseases. Our innovative antibody platforms combine multiple biologic components into a single molecule, offering greater versatility and potency against complex diseases than traditional approaches. Our pipeline includes candidates targeting both solid and hematological tumors, as well as several of the world's most pressing viral threats. Our leadership team consists of globally recognized medical innovators with a strong track record of delivering breakthroughs for patients.
Position OverviewThe Medical Director will be a key member of the program and clinical development teams, playing a pivotal role in shaping and executing clinical strategies for immuno-oncology programs. This role requires strong medical judgment, collaboration, leadership, and communication skills, along with a deep understanding of clinical development, regulatory processes, and industry best practices. The Medical Director will also be responsible for clinical study oversight, medical monitoring, and fostering relationships with trial investigators and key opinion leaders.
Key ResponsibilitiesMedical Monitoring: Provide medical oversight for ongoing clinical trials, including safety monitoring, data analysis, and interpretation of clinical trial results. Work closely with the study team to prepare, review, and finalize clinical and safety documentation.
Clinical Strategy: Contribute to the development and execution of clinical development plans for immuno-oncology programs. Provide insights on study data, protocols, reports, and overall development strategies. Collaborate with early development teams on disease indications and clinical aspects.
Clinical Trial Design: Assist in designing and overseeing clinical trials, ensuring compliance with regulatory standards and ethical guidelines. Develop and review study protocols, case report forms, monitoring manuals, and informed consent documents.
Regulatory Engagement: Partner with regulatory teams to prepare and submit key documents, including INDs, NDAs, and BLAs. Engage with health authorities to support program advancement.
Key Opinion Leader (KOL) Engagement: Build and maintain strong relationships with key opinion leaders and academic institutions to advance scientific and clinical objectives.
Cross-Functional Collaboration: Work closely with research and development, clinical operations, and regulatory affairs to ensure alignment and execution of program goals.
Scientific Communications: Present clinical trial updates to internal and external stakeholders and contribute to scientific publications, presentations, and educational materials.
MD with at least 5 years of drug development experience in the pharmaceutical or biotechnology industry.
Oncology drug development experience is required , including the development of biologics; experience in infectious diseases is a plus.
Strong understanding of regulatory requirements and prior interactions with regulatory agencies.
Ability to work independently and collaboratively as a subject matter expert in cross-functional teams.
Excellent verbal and written communication skills.
Strong analytical and problem-solving abilities.
Proven track record of successful clinical trial design and execution.
Exceptional leadership and interpersonal skills.
Board certification in the United States, with a preference for hematology-oncology.
Experience in translational medicine and biomarker development.
This is an exciting opportunity to be part of a pioneering team focused on developing transformative therapies for patients with cancer and infectious diseases.
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