Role Summary
The Senior Medical Director, IRF5 Program will serve as the clinical lead for one or more indications within Kymeraโs IRF5 clinical development program, a first-in-class therapeutic approach, leveraging targeted protein degradation to modulate innate immune signaling in immune-mediated diseases. This individual will be responsible for driving the clinical strategy of the program, including clinical trial design, execution, data interpretation, and regulatory interactions. This is a unique opportunity to help shape the clinical development of a first-in-class therapy with the potential to transform treatment paradigms in autoimmune disease. This role requires deep clinical insight, cross-functional collaboration, and leadership in advancing novel therapies from early clinical development through late-stage trials.
Responsibilities
- Serve as the clinical lead for one or more clinical indications within the IRF5 program, overseeing all aspects of clinical strategy and execution.
- Integrate translational and biomarker data into clinical strategy to refine patient selection and endpoint development.
- Lead the design and implementation of clinical studies, ensuring scientific rigor and patient safety.
- Collaborate with external partners, academic institutions, and consortia to advance the scientific and clinical development strategy.
- Provide strategic medical leadership to cross-functional teams, including development sub-teams and clinical study teams.
- Provide medical oversight during clinical trial conduct, including safety monitoring, data review, and protocol amendments as needed.
- Contribute to the development of clinical and regulatory documents (protocols, IBs, CSRs, regulatory submissions).
- Contribute to hiring, coaching, and development of clinical development talent.
- Represent Kymera in scientific, regulatory, and clinical forums, including interactions with KOLs, investigators, and advisory boards.
Qualifications
- Required: MD or MD/PhD with board certification in Rheumatology, Immunology, or a related discipline. Minimum of 4 years of experience in clinical drug development, ideally in biotechnology or pharmaceutical settings.
- Required: Experience interacting with global regulatory agencies (e.g., FDA, EMA) and preparing briefing documents for regulatory submissions.
- Required: Proven track record in designing and executing clinical trials (Phase IโIII) and contributing to successful regulatory interactions.
- Required: Strong understanding of translational science, biomarkers, and mechanistic drug development.
- Required: Demonstrated ability to lead cross-functional teams and manage multiple programs in parallel.
- Required: Entrepreneurial mindset and passion for advancing first-in-class therapies in a collaborative, science-driven environment.
- Required: Excellent leadership, communication, and collaborative skills; ability to thrive in a fast-paced, matrixed environment.
Skills
- MD or MD/PhD with board certification in Rheumatology, Immunology, or a related discipline (as above).
- Experience in clinical drug development and regulatory submissions.
- Strong leadership, communication, and collaboration capabilities.