Assoc Dir​/Director Clinical Scientist

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

• Lead the clinical study protocol development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents.
• In collaboration with internal/external experts on biostatistics, clinical pharmacology, translational medicine, clinical operations and data management, contributes to the development of the plan to execute on trial design including CRF design, data review plan, statistical analysis plan review and finalization.
• Collaborate within Development on the review, analysis, and interpretation of study results and assures appropriate data review and accurate data reporting.
• Identify study issues and program issues by reviewing and monitoring of emerging clinical data related to safety, efficacy and PK/PD. Develops sound, strategic solutions to issues and collaborates with the clinical study team to ensure issue resolution. Conduct literature reviews as needed for the interpretation of study data and development of next steps.
• Works closely with the medical monitor to assure he/she is informed of pertinent study information, including but not limited to safety and efficacy data.
• Support the development of program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
• Translational medicine:
  Support the implementation of target/pathway engagement assays for selecting therapeutically relevant doses and schedules; support stratification biomarkers.
• In conjunction with the VP Development/CMO, develop presentations and communicate study data results to colleagues internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences.
• Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
• Serve as clinical science representative on cross-function teams as assigned.

• Candidates should have an advanced clinical or science degree (e.g. RN, MA, PharmD, NP, PhD).
• Must have a minimum of MA + 5 years of clinical or PharmD/PhD +3 years.
• Technical/operational experience in planning, executing, reporting and publishing clinical studies within the pharmaceutical industry.
• Demonstrated ability to review and summarize study data, including experience in preparing and presenting data.
• Fluency in the English language, both written and verbal.
• Thorough understanding of the drug development process from pre-IND through registration and post-registration required.
• Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization).
• Ability to understand, interpret and communicate clinical information including literature reviews, competitive…