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 role offers an opportunity to influence the clinical development of a first-in-class therapy with potential to transform treatment paradigms in autoimmune disease.
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
- MD or MD/PhD with board certification in Rheumatology, Immunology, or a related discipline. Candidates with alternative certifications and substantial clinical development experience in relevant therapeutic areas will also be considered. Minimum of 4 years of experience in clinical drug development, ideally in biotechnology or pharmaceutical settings.
- Experience interacting with global regulatory agencies (e.g., FDA, EMA) and preparing briefing documents for regulatory submissions.
- Proven track record in designing and executing clinical trials (Phase IโIII) and contributing to successful regulatory interactions.
- Strong understanding of translational science, biomarkers, and mechanistic drug development.
- Demonstrated ability to lead cross-functional teams and manage multiple programs in parallel.
- Entrepreneurial mindset and passion for advancing first-in-class therapies in a collaborative, science-driven environment.
- Excellent leadership, communication, and collaborative skills; ability to thrive in a fast-paced, matrixed environment.
Skills
- Leadership and strategic medical oversight across multi-disciplinary teams.
- Strong collaboration with external partners, academia, and regulatory bodies.
- Analytical mindset with ability to integrate translational data and biomarkers into clinical development.
- Effective communication for regulatory discussions, publications, and scientific forums.