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 part of something bigger, with a lasting impact that you can be proud of. We strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

About the Role

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. To succeed at Kura, you will need 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.

Responsibilities

• Lead the clinical study protocol development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents.
• Collaborate with internal/external experts on biostatistics, clinical pharmacology, translational medicine, clinical operations, and data management to develop 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 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.
• Conduct literature reviews as needed for the interpretation of study data and development of next steps.
• Work 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.
• 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-functional teams as assigned.

Requirements

• Advanced clinical or science degree (e.g., RN, MA, PharmD, NP, PhD).
• Minimum of MA + 5 years of clinical or PharmD/PhD + 3 years of experience.
• 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.
• 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 intelligence, and changing treatment paradigms to support a robust clinical development strategy.
• Understanding of trial design and statistics to apply knowledge to the design of clinical protocols.
• Successful track record for interpreting, analyzing, and presenting clinical data, including aggregate data analyses, to inform decision-making and set clinical strategy.
• Hands-on experience performing systematic literature searches, summarizing results, and presenting conclusions to a wide spectrum of audiences.
• Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and incorporation of multiple points of view.
• Strong organization, documentation, and communication skills with an ability to multitask.
• Excellent interpersonal skills and 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.

Pay

The base range for an Associate Director is $180,000 - $222,000 and a Director is $226,000 - $264,000 per year. Individual pay may vary based on additional factors, including job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

Benefits

• Career advancement and 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 and 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 more

About Kura Oncology

Kura Oncology is a commercial-stage biopharmaceutical company committed to discovering and developing innovative precision medicines to help patients with cancer lead better, longer lives. Through our deep understanding of cancer biology and decades of experience in precision oncology, we study the underlying causes of treatment resistance. This enables us to design smart combination regimens with other cancer therapies to target tumors from multiple directions, with the goal of improving long-term clinical benefit. Kura developed and is commercializing KOMZIFTI® (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition.