Senior Manager, Clinical Data Management - Kura Oncology
Boston, MA
About the Job
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:
Key responsibilities include oversight of outsourced data management & EDC activities by service providers, performing and coordinating internal study team data review, and delivery of fit for purpose clinical data in support of study milestones.
- Provide clear, consistent communication to Kura's CROs and 3rd party Vendors with respect to data management deliverables and monitor performance against communicated expectations.
- Coordinate internal team review and feedback during EDC builds and/or migrations and provide clear guidance to external DM and EDC build team throughout.
- Accountable for DM task and milestone timelines
- Responsible for ensuring data quality and integrity for clinical study data collection activities.
- Work with clinical team to define and maintain the Kura Comprehensive Data Review Plan.
- Lead Kura study team in the review of clinical study data per Comprehensive Data Review Plan.
- Prepare and provide internal data listings and reports as required.
- Review protocols for data collection and management feasibility.
- Provide leadership to the study team with respect to data management activities throughout the study lifecycle: planning, start-up, conduct, close-out.
- Accountable for the creation and delivery of DM documentation (i.e., eCRFs, CCGs, DMP, Data Transfer Specifications, etc.); ensure documentation is appropriately filed within the Trial Management File (TMF).
- Review study budgets and provide input on data collection, cleaning, and reporting as it relates to development of vendor contracts
- Partner with internal content experts to manage and coordinate data collection/maintenance with external vendors; ensure deliverables are identified and met according to project milestones and program/project objectives.
- Responsible for tracking and documenting data management decisions.
- Responsible for initiating and chairing meetings associated with assigned studies and initiatives
- Provide support and contribute to the development of clinical trial timelines as it relates to data management activities.
- Manage accruals tracking and vendor payments for data management activities.
- Contribute to the development of departmental procedures documentation.
- Complete other duties as assigned by the manager.
JOB SPECIFICATIONS:
- A./B.S. degree in Biology, Mathematics, Computer Science or related scientific field.
- 5+ years' experience in data management or relevant work in the pharmaceutical/biopharma industry.
- Experience in oncology strongly preferred.
- Experience in managing DM activities throughout the study lifecycle (planning, start-up, conduct, close-out)
- Significant experience providing oversight for database migrations.
- Experience with an NDA submission desirable
- Strong project management skills
- Strong vendor management skills (e.g. Biomarkers, Labs, Imaging, ECG).
- Able to provide independent DM subject matter expertise to study teams and vendors in defining, managing, & delivering on DM obligations.
- Experience working in 1 or more EDC platforms (Rave, InForm, etc.).
- Experience working in a data integration/visualization platform (e.g. Saama, elluminate) desirable
- Solid understanding of clinical drug development process and knowledge of regulatory requirements and ICH/GCP guidelines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Excellent interpersonal skills in addition to verbal and written communication skills.
- Strong Excel skills, SAS experience a plus
- Flexibility to travel up to approximately 5% of time.
The base range for this role depending on level is is $163,000 to $195,000per 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
- 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!
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 three investigational drug candidates: ziftomenib, tipifarnib and KO-2806. Ziftomenib is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need. Ziftomenib is currently enrolling patients in a Phase 2 registration-directed trial (KOMET-001) in NPM1-mutant relapsed or refractory AML. Kura is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients with PIK3CA-dependent HNSCC. Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors. For additional information, please visit Kura's website at www.kuraoncology.com.
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.