Assoc Dir/Director Clinical Scientist
Kura Oncology, Inc.
August 31, 2026
On-site
United States
Clinical Research and Development
Essential Job Functions:
- Lead the clinical study protocol development process by translating strategy into executable clinical protocols and related documents.
- Collaborate with biostatistics, clinical pharmacology, translational medicine, clinical operations, and data management to plan trial design (CRF design, data review plan, statistical analysis plan review/finalization).
- Review, analyze, and interpret study results; ensure appropriate data review and accurate reporting.
- Identify study/program issues via emerging clinical data (safety, efficacy, PK/PD); develop solutions and partner with the clinical study team for resolution; conduct literature reviews for interpretation and next steps.
- Work with the medical monitor to ensure awareness of pertinent study information (including safety and efficacy).
- Support program/regulatory documents (IND, clinical study reports, investigator brochures, annual reports/updates, and clinical sections of regulatory submissions).
- Translational medicine: support target/pathway engagement assays for dose/schedule selection; support stratification biomarkers.
- Present/communicate study results internally and externally (including investigators and scientific conferences).
- Maintain knowledge of the external scientific environment to inform trial strategy; serve as clinical science representative on cross-functional teams.
Job Specifications/Qualifications:
- Advanced clinical or science degree (e.g., RN, MA, PharmD, NP, PhD).
- Minimum experience: MA + 5 years OR PharmD/PhD + 3 years.
- Experience planning/executing/reporting/publishing clinical studies in pharma.
- Ability to review/summarize/present study data.
- English fluency (written/verbal).
- Drug development knowledge (pre-IND through registration and post-registration) and functional areas (preclinical, regulatory, pharmacovigilance, drug supply, data sciences, clinical operations).
- Trial design/statistics knowledge; strong communication, documentation, organization, multitasking, and collaboration.
- GCP, ICH, and US FDA regulations; travel up to ~30%.
Benefits:
- Base range: Associate Director $180,000–$222,000; Director $226,000–$264,000. Bonus, equity.
- Career development, 401K + employer contributions, stock options, ESPP, 20 days PTO, 18 holidays, benefits package, paid paternity/maternity leave, catered lunches, home office setup, lifestyle spending stipend, commuter stipend, social activities.
- Lead the clinical study protocol development process by translating strategy into executable clinical protocols and related documents.
- Collaborate with biostatistics, clinical pharmacology, translational medicine, clinical operations, and data management to plan trial design (CRF design, data review plan, statistical analysis plan review/finalization).
- Review, analyze, and interpret study results; ensure appropriate data review and accurate reporting.
- Identify study/program issues via emerging clinical data (safety, efficacy, PK/PD); develop solutions and partner with the clinical study team for resolution; conduct literature reviews for interpretation and next steps.
- Work with the medical monitor to ensure awareness of pertinent study information (including safety and efficacy).
- Support program/regulatory documents (IND, clinical study reports, investigator brochures, annual reports/updates, and clinical sections of regulatory submissions).
- Translational medicine: support target/pathway engagement assays for dose/schedule selection; support stratification biomarkers.
- Present/communicate study results internally and externally (including investigators and scientific conferences).
- Maintain knowledge of the external scientific environment to inform trial strategy; serve as clinical science representative on cross-functional teams.
Job Specifications/Qualifications:
- Advanced clinical or science degree (e.g., RN, MA, PharmD, NP, PhD).
- Minimum experience: MA + 5 years OR PharmD/PhD + 3 years.
- Experience planning/executing/reporting/publishing clinical studies in pharma.
- Ability to review/summarize/present study data.
- English fluency (written/verbal).
- Drug development knowledge (pre-IND through registration and post-registration) and functional areas (preclinical, regulatory, pharmacovigilance, drug supply, data sciences, clinical operations).
- Trial design/statistics knowledge; strong communication, documentation, organization, multitasking, and collaboration.
- GCP, ICH, and US FDA regulations; travel up to ~30%.
Benefits:
- Base range: Associate Director $180,000–$222,000; Director $226,000–$264,000. Bonus, equity.
- Career development, 401K + employer contributions, stock options, ESPP, 20 days PTO, 18 holidays, benefits package, paid paternity/maternity leave, catered lunches, home office setup, lifestyle spending stipend, commuter stipend, social activities.