Assoc Dir/Director Clinical Scientist

Kura Oncology; Boston (MA); Hybrid; USD 180,000 - 264,000; Full time

Benefits offered by this job

Competitive compensation

Equity

401K + employer contributions

Generous benefits package

Paid time off

Job summary

Kura Oncology in Boston is seeking an Associate Director/Director of Clinical Development to lead protocol development, collaborate with biostatistics, translational medicine, data management, and drive study design from concept through regulatory submissions.

The role requires an advanced clinical or science degree and 5+ years in clinical development (PharmD/PhD +3) with strong knowledge of GCP, ICH, and FDA regulations; travel up to 30%. Competitive compensation and equity.

Qualifications

• Advanced clinical or science degree required (RN/MA/PharmD/NP/PhD).
• Minimum of MA + 5 years in clinical development or PharmD/PhD +3 years.
• Experience planning, executing, reporting and publishing clinical studies in pharma.

Responsibilities

• Lead protocol development translating strategy into executable clinical trials.
• Collaborate with biostatistics, pharmacology, translational medicine, operations, and data management.
• Review results, ensure data quality, and support regulatory submissions.
• Identify study or program issues and develop strategic solutions.
• Partner with medical monitor to convey safety/efficacy data to stakeholders.
• Contribute to INDs, clinical study reports, and investigator brochures.

Skills

Clinical development

Study design

Data interpretation

Regulatory collaboration

Cross-functional leadership

GCP/ICH knowledge

Education

Advanced clinical or science degree (RN/MA/PharmD/NP/PhD)

Job 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.

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.

ESSENTIAL JOB FUNCTIONS:

• 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.

JOB SPECIFICATIONS:

• 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 intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy.
• 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, including aggregate data analyses, in order to inform decision-making and set clinical strategy.
• Hands-on experience performing systematic literature search, summarizing the search results and presenting the conclusions to wide spectrum of audience.
• Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view.
• 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.

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, and without limitation, 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.

Kura’s Values that are used for candidate selection and performance assessments:

• We work as one for patients
• We are goal-focused and deliver with excellence
• We are science-driven courageous innovators
• We strive to bring out the best in each other and ourselves

The Kura Package

• Competitive comp 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!

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 are studying 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. For additional information, please visit Kura’s website atwww.kuraoncology.com and follow us on X and LinkedIn .

Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

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