[Hiring] Assoc Dir/Director Clinical Scientist @Kura Oncology

Role Description

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.

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, contribute 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 assure appropriate data review and accurate data reporting.
• Identify study issues and program issues by reviewing and monitoring emerging clinical data related to safety, efficacy and PK/PD. Develop sound, strategic solutions to issues and collaborate with the clinical study team to ensure issue resolution.
• 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.
• Support the implementation of target/pathway engagement assays for selecting therapeutically relevant doses and schedules; support stratification biomarkers.
• 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.

Qualifications

• 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, and clinical operations.
• Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms.
• Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols.
• Successful track record for the ability to interpret, analyze, and present clinical data.
• Hands-on experience performing systematic literature search, summarizing the search results and presenting the conclusions.
• Ability to work effectively in a collaborative team environment.
• Strong organization, documentation and communication skills with an ability to multitask.
• Excellent interpersonal skills: ability to collaborate across disciplines.
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
• Ability to travel up to approximately 30% of the time.

Benefits

• Career advancement/development opportunities.
• Competitive compensation package.
• Bonus.
• 401K + Employer contributions.
• Generous stock options.
• ESPP Plan.
• 20 days of PTO to start.
• 18 Holidays (Including Summer & Winter Break).
• Generous Benefits Package with a variety of plans available with a substantial employer match.
• Paid Paternity/Maternity Leave.
• In-Office Catered lunches.
• Home Office Setup.
• Lifestyle Spending Stipend.
• Commuter Stipend (Boston Office).
• Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!