AD/Director, Clinical Data Sciences

Kura Oncology, Inc.•Boston, MA

44d

About The Position

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: This is a leadership position working with the Clinical Trial Management and Clinical Development functions to drive program execution of data science deliverables, operational excellence, implement scalable data processes, and provide scientific and technical leadership to ensure data integrity and regulatory compliance. The role is ideal for an experienced data sciences leader who thrives in a fast-paced, hands-on environment.

Requirements

B.A./B.S. or MA/MBA degree in Biology, Health Sciences, or related scientific field required.
10+ years in clinical data management/sciences within the pharmaceutical or biopharma industry.
Prior leadership experience managing teams and overseeing multiple studies.
Oncology experience.
Extensive experience in managing external vendors (CROs, central laboratories, etc).
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Demonstrated expertise in EDC systems (Veeva EDC, Medidata Rave, etc.), data visualization platforms, and CDISC standards.
Excellent communication skills.
Analytical thinker with a data-driven mindset and attention to detail.
Knowledge of health authorities' rules and regulations governing clinical data collection, storage, transmission, and privacy.
Flexibility to travel approximately 5-10% of time.

Responsibilities

Serve as the accountable data sciences leader for key programs, ensuring proactive risk management and issue resolution.
Develop and execute the clinical data sciences strategy to support program pipeline and portfolio goals.
Oversee end-to-end data management activities from study start-up through submission, including protocol development, database design, data cleaning, and lock.
Ensure timely and accurate delivery of clinical data to support interim analyses, database locks, and regulatory submissions.
Ensure study documentation and filing is maintained in an inspection ready state and provide leadership and direct support as required for audits and regulatory inspections.
Oversee vendor partnerships (CROs, EDC providers, and other data service partners) and ensure adherence to timelines, budgets, and quality standards.
Promote a culture of quality, innovation, and collaboration across operations and development functions.
Drive process optimization and digital transformation initiatives.
Provide direct study support as may be required to support business objectives.
Lead and mentor a high-performing clinical data sciences team.
Support establishment and maintenance of data standards in accordance with industry guidelines.
Complete other duties assigned by manager.

Benefits

Career advancement/ development opportunities
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!