Associate Director, Clinical Scientist, Immunology
Kymera Therapeutics
1 month ago
Remote friendly (Greater Boston)
United States
Clinical Research and Development
How you’ll make an impact:
- Serve as the study level Clinical Scientist in immunology, participating in study team meetings, vendor meetings, and data/safety monitoring committees.
- Support the design of clinical trial protocols and amendments; ensure scientific integrity and alignment with regulatory standards. Collaborate with Translational Medicine to integrate biomarker testing and with Clinical Pharmacology to integrate pharmacokinetic sampling.
- Prepare and review essential documents including medical monitoring plans, statistical analysis plans, informed consent forms, case report forms, and clinical study reports.
- Support study execution as a scientific subject matter expert.
- Conduct clinical data reviews, including safety monitoring, to ensure patient safety and data accuracy/integrity.
- Perform data review/cleaning/monitoring using data visualization tools and review protocol deviations to identify risks and implement mitigation strategies.
- Support IRB and regulatory submissions and query responses.
- Present data to external investigators and internal stakeholders, including meetings with governance bodies and regulatory authorities.
- Work in a matrix environment collaborating with medical directors, regulatory affairs, translational medicine, clinical operations, data management, biostatistics, and other functions to advance clinical programs.
Skills and experience you’ll bring:
- Bachelor’s or advanced degree (MSc, PharmD, MD, PhD) in Life Sciences or related field.
- 4+ years in pharmaceutical clinical drug development, including global clinical trials and program execution.
- Experience in immunological diseases (e.g., Systemic Lupus Erythematosus, Inflammatory Bowel Disease) with knowledge of disease biology and treatment landscapes.
- In-depth understanding of clinical development processes, regulatory requirements, and guidelines (FDA, EMEA, ICH, GCP).
- Strong critical-thinking/problem-solving and excellent medical writing skills.
Compensation:
- Anticipated base salary range: $160,000–$240,000; eligible for annual bonus, equity participation, and comprehensive benefits.
- Serve as the study level Clinical Scientist in immunology, participating in study team meetings, vendor meetings, and data/safety monitoring committees.
- Support the design of clinical trial protocols and amendments; ensure scientific integrity and alignment with regulatory standards. Collaborate with Translational Medicine to integrate biomarker testing and with Clinical Pharmacology to integrate pharmacokinetic sampling.
- Prepare and review essential documents including medical monitoring plans, statistical analysis plans, informed consent forms, case report forms, and clinical study reports.
- Support study execution as a scientific subject matter expert.
- Conduct clinical data reviews, including safety monitoring, to ensure patient safety and data accuracy/integrity.
- Perform data review/cleaning/monitoring using data visualization tools and review protocol deviations to identify risks and implement mitigation strategies.
- Support IRB and regulatory submissions and query responses.
- Present data to external investigators and internal stakeholders, including meetings with governance bodies and regulatory authorities.
- Work in a matrix environment collaborating with medical directors, regulatory affairs, translational medicine, clinical operations, data management, biostatistics, and other functions to advance clinical programs.
Skills and experience you’ll bring:
- Bachelor’s or advanced degree (MSc, PharmD, MD, PhD) in Life Sciences or related field.
- 4+ years in pharmaceutical clinical drug development, including global clinical trials and program execution.
- Experience in immunological diseases (e.g., Systemic Lupus Erythematosus, Inflammatory Bowel Disease) with knowledge of disease biology and treatment landscapes.
- In-depth understanding of clinical development processes, regulatory requirements, and guidelines (FDA, EMEA, ICH, GCP).
- Strong critical-thinking/problem-solving and excellent medical writing skills.
Compensation:
- Anticipated base salary range: $160,000–$240,000; eligible for annual bonus, equity participation, and comprehensive benefits.