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.
Clinical Diagnostics Associate
We’re looking for an innovative Clinical Diagnostics Associate to join the clinical development team and report to the Senior Director, Diagnostics.
The Clinical Diagnostics Associate will provide project oversight, support, and program management for biomarker and diagnostic projects for the Kura Oncology precision oncology pipeline. This position will collaborate with both external biomarker and diagnostic testing providers and internal clinical development and clinical operations teams in a small fast-paced, dynamic work environment. They will assist in managing the development, outsourcing, and validation of clinically applicable biomarker testing and diagnostic assays.
ESSENTIAL JOB FUNCTIONS:
- Manage biospecimen sample sourcing for internal Kura Translational Medicine projects, external biomarker testing, and Companion Diagnostics analytical validation. Utilize technical and clinical insights to source the appropriate biospecimens for assay validation activities.
- Work with external vendors and service providers on contracting and monitoring of assay development and sample testing projects, including financial transactions between Kura and them.
- Track project progress and proactively evaluate potential delays and adverse situations and escalate them to the manager immediately.
- Support the biomarker testing and companion diagnostic strategies in accordance with the requirements of quality, ethical, and regulatory standards, including ICH/GDPR/GCP/GLP.
- Support Companion Diagnostic partnership requests and actively participate in Joint Project Team calls. Ensure that the meeting minutes are captured appropriately, including all action items.
- Support Clinical Operations on the lifecycle of patient samples for biomarker testing and diagnostic technology development, including sample procurement from commercial sources (biobanks and biorepositories), sample collection at study sites, processing, storage, transfer to central lab, shipment to vendors for testing, analysis, input on relevant documentation, and final sample disposition (including long-term storage), while maximizing sample quality based on biomarker testing and diagnostics sample requirements. Be the point person to support Clinical Operations requests and obtain technical and regulatory input from other Diagnostic Team members when needed.
- Utilize available internal and external tracking systems to monitor and report progress, address issues, and ensure resolutions relating to samples that will be used for biomarker testing and diagnostics. Ensure that all risks related to biomarker testing and diagnostic technologies are accurately captured for the Kura Project Management Team.
- Support data transfer agreements (DTAs) and monitor and report progress, address issues and ensure resolutions relating to biomarker testing and diagnostic data transfers. Be the point person for Kura Data Management Team.
- Address questions from the Kura program teams on biomarker testing and companion diagnostic vendors regarding sample collection, handling, transfer, testing, storage, etc. for all biomarker testing and companion diagnostics projects.
- Support Diagnostics Team on contracts, budgets, project, and development timelines and work closely with the Kura Finance and Project Management Team to ensure that information is accurately captured.
- Invite and process work proposals for Kura’s diagnostic projects and biomarker testing. Be the point person for obtaining proposals, work orders, statements of works, etc. from diagnostic and biomarker testing vendors based on the technical and regulatory needs related to the testing.
- Provide support for all activities involving start-up execution and close-out of all contracts, budgets, and timelines.
- Bring issues to Manager or Program team’s as necessary and participate in the resolution of delays or potential delays.
- Manage Diagnostics team meetings as well as minutes, agendas, action items, etc. Prepare PowerPoints summarizing progress for Senior Leadership.
- Respond to changing duties as responsibilities may vary based on potential pipeline growth, project needs, and stages of development (pre-clinical, clinical or commercial).
- BS, MS, in Biochemistry, Biology, Medical Technology, immunology, pharmacy, or related pharmaceutical science.
- 2-4 years of work experience in drug development, diagnostics, or clinical trial management.
- Experience with Microsoft Office, including Excel, required. Experience with Microsoft Project as well as other database and timeline management software preferred but not essential.
- Assay development experience preferred.
- High level of integrity, accuracy, and attention to detail.
- Self-organized, self-directed, highly motivated with strong critical thinking and analytical skills.
- Willingness to work collaboratively, think critically, and incorporate diverse perspectives into decision-making.
- Demonstrated ability to work successfully in a nimble, fast-paced matrixed environment.
- Outstanding interpersonal, communication, and negotiation skills.
THE KURA PACKAGE
- Career advancement/ development opportunities
- Competitive comp package
- 401K + Employer contributions
- Generous stock options
- ESPP Plan
- 20 days of PTO to start
- 14 Holidays + 3 Floater Holidays (Including Winter Break), Summer Hours
- 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
- Cell Phone and Wellness 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 clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of solid tumors and blood cancers. The company’s diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology’s approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts.
Kura’s pipeline consists of Tipifarnib and KO-539. Tipifarnib is a farnesyl transferase inhibitor that recently received Breakthrough Therapy Designation (BTD) for the treatment of patients with certain head and neck cancers that carry HRAS mutations. Tipifarnib will also be evaluated in combination with an inhibitor of PI3Kalpha to treat between 20-50% of patients with HNSCC, the 7th largest cancer worldwide. KO-539 is an inhibitor of the menin/MLL interaction, which is are critically important for survival, growth, and proliferation leukemic blasts. Kura recently presented preliminary clinical data for KO-539 at the 2020 American Society of Hematology (ASH) meeting that demonstrated that it demonstrates favorable safety and tolerability and compelling evidence of activity in genetically defined AML patients.
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. To apply, please submit your resume to email@example.com