Position: Senior Director/VP Head of Clinical Data Management
Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
The Senior Director/VP, Head of Clinical Data Management is a Leadership position, responsible for oversight of Clinical Data Management. This role supports all clinical development programs including CRO/EDC vendor selection and management, CDM contracts negotiations and management, timelines oversight, CDM department budget maintenance and management, data metrics & reporting oversight, and CDM staffing/resource and retention oversight/management, working closely with internal and external vendors to ensure clean, solid and timely deliverables supporting all Clinical Data submissions.
- Assess and oversee project plans and timelines as well as assign and effectively manage CDM staff to ensure all projects/programs are appropriately prioritized and key goals are achieved in correlation with defined timelines
- Oversight of key performance indicators, metrics, and program level deliverables and timelines
- Represent Karyopharm regarding Clinical Data issues with internal and external parties/partners, CROs and vendors, including global regulatory agencies
- Oversee the CDM Team is effectively working with and supporting Clinical, Pharmacovigilance, Programming, Biostatistics, Medical Affairs, CMC, Finance, Contracts, Legal, Quality and Regulatory Affairs personnel in preparation of data deliverables to support Database/IRT Go Live, DSMB/DMC meetings, Development Safety Update Reports, Interim Analyses, Database Locks , ( e.g. statistical analysis plans) and analyses (e.g. safety and efficacy analyses)and investigative brochures and any Ad Hoc deliverable
- Collaborate with HR in recruiting and selecting appropriately skilled and trained CDM candidates for employment
- Work with Medical Writing personnel in preparation of clinical study reports and other regulatory documents including NDA
- Effectively works with cross-functional leaders to achieve corporate and department goals and objectives.
- Effectively interact with senior members of other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives.
- Establish/update processes and procedures for CDM Department to meet Regulatory requirements and guidelines such as Standard Operating Procedures, Work Instructions, etc.
- Supervisory and leadership responsibilities for all data management and back-end activities supporting Karyopharm clinical programs from Data Management strategy, database start-up through database lock and CSR/submission.
- Support Corporate goals and business strategies to identify Clinical Data Management policies for implementation such as: SOPs, new technologies, clinical data standards, and preferred vendors
- Implement and approve new Clinical Data Management policies and methodologies.
- Supports the development of request for proposals (RFPs) for external vendor cross-functional/organizational contracts. Review external vendor cross-functional/organizational contracts and budget for appropriateness to the project when requested
- Oversight of build, validation, and maintenance of clinical trial databases in accordance with ICH/GCP guidelines and current regulatory requirements.
- Responsible for resource planning, CDM department re-forecasting, program milestones
- Oversee and execute employee performance evaluations, goal setting, career development, and departmental growth to meet Corporate needs aligning with Annual Corporate Budgets
- Perform other activities as required by Corporate need
- Ensure inspection readiness in all DM related domains and activities
- 10+ years Clinical Data Management experience
- Proven experience in managing a team of 5 people or more
- BS/BA Degree or higher
- NDA, ODAC and IND proven experience
- Oncology experience (multiple indications)
- Strong Knowledge of ICH GCP
- Strong relationship skills
- Strong verbal and written communication skills
- Ability to effectively work in a fast paced, fluid environment
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