Location:USA Type:Full Time, Remote / Home-based Therapeutics:Oncology & Autoimmune Diseases Industry:Drug discovery and development of the next-generation ADC therapeutics
Responsibilities:
Provide medical leadership and expertise in the development and implementation of strategies and serve as the key medical representative for assigned TA projects, ensuring alignment with strategic goals and regulatory requirements, and driving clinical trials and research initiatives
Lead assigned TA clinical trials, ensuring regulatory compliance, patient safety, and data integrity in protocol execution.
Stay current with advancements in assigned TA research and treatment modalities, contributing to the organization's knowledge base.
Assure compliance through QA initiatives, and regulatory adherence, and offer medical support in submissions and interactions.
Requirements:
Medical Doctor (MD) degree with prior 3+ exposure in handling oncology and/or autoimmune disease programs in pharma/biotech industry settings
Advanced degree (PhD), experience in relevant therapeutic areas, product launches, and engagement with stakeholders a plus
Extensive experience in clinical practice, research, or medical affairs
Strong understanding of regulatory requirements (FDA, ICH) in oncology / autoimmune diseases-related clinical research
Excellent communication, interpersonal, and presentation skills