The Medical Director, T-Detect is a core member of Adaptive’s Clinical Development and Medical Affairs team. This position is responsible for advancing Adaptive’s scientific insights into viable clinical products and will support strategy and clinical data generation for T-Detect products for existing and new clinical indications across autoimmune diseases, oncology, and infectious diseases. This leader will develop and execute translational strategies to further the development of Adaptive’s current and future diagnostic products with an autoimmune disease focus to start and opportunities in therapeutics and drug discovery. The successful candidate will work cross-functionally to further clinical development strategy across potential applications in alignment with the Antigen Map and Molecular Product Development teams. The Medical Director will also develop and manage clinical protocols and validation studies that meet regulatory requirements.
Responsibilities
- Primarily responsible for development and execution of clinical strategy for T-Detect programs, in collaboration with Antigen Map team to ensure alignment between R&D objectives and unmet clinical need
- Establish and drive teams to execute the strategic long-term vision for T-Detect programs in alignment with Antigen Map research teams
- Lead clinical study teams and development with maintenance of clinical documents (e.g. protocols and amendments, investigator brochures, clinical study reports) to be used in regulatory interactions and filings
- Serve as key clinical expert to Access and Commercial teams in order to support the data generation and medical education required to support launch and uptake
- Support cross-functional strategic, operational and launch planning, providing clinical views and insights
- Advise on current and future clinical development plans within internal and joint development teams to broaden existing and secure new clinical opportunities
- Serve as a key clinical expert in generation of regulatory documents and filings, including support for regulatory call and in-person meetings with authorities
- Represent Adaptive externally and deliver scientific presentations with a broad audience including academic institutions, integrated delivery networks, advocacy groups, and regulatory bodies
Requirements
- MD or MD/PhD; (Board-certified preferred)
- At least 1-2 years biotech industry experience in therapeutics or diagnostics development