Senior Director, Clinical Data Management
Exelixis
10 hours ago
Remote friendly (Alameda, CA)
United States
$232,000 - $330,000 USD yearly
Clinical Research and Development
Essential Duties/Responsibilities:
- Provide strategic and operational leadership for Clinical Data Management (CDM) activities across clinical studies Phase I–IV (internal FTEs, FSP resources, and fully outsourced studies across geographies).
- Lead assigned clinical programs as a key member of the CDM Senior Leadership Team.
- Drive development of CDM capabilities and shape organizational structures across a growing, complex functional portfolio.
- Lead and coach employee development (including Director-level individuals); manage recruiting and training within departmental scope.
- Represent CDM in cross-functional discussions and step in for Head of CDM as needed; collaborate closely with senior R&D and matrix leaders.
- Align with Business/Functional/TA heads on portfolio objectives to influence CDM strategy and ensure quality, efficient, and compliant CDM deliverables.
- Manage CDM workload and ensure appropriate resource allocation (including vendor engagement/utilization).
- Continuously develop and adjust innovative operating models; improve productivity and effectiveness.
- Lead departmental process development/optimization and sponsor initiatives driving change within/across functions.
- Engage cross-functional senior leadership to deliver solutions for new service capabilities.
- Contribute to performance metrics and identify ways to raise standards; ensure team adherence to standards and compliance.
- Attract and retain top talent; ensure effective, transparent communication and an engaged, empowered environment.
Supervisory Responsibilities:
- Directly and indirectly supervise employees.
- Responsible for growth and development of Director-level and below employees.
Qualifications / Experience / Education:
- BS/BA + 15+ years; or MS/MA + 13+ years; or PhD + 12+ years; or equivalent combination.
- Typically 17+ years related experience (or combination of education/training).
- Required: Biotech/Pharmaceutical industry; demonstrated leadership of global data management teams; experience participating in regulatory submissions and inspections; minimum 10 years line management.
- Required: Extensive people leadership (talent development and performance management) for a Clinical Data Management organization.
- Preferred: Oncology clinical trials experience; leading major change initiatives; experience developing Director-level colleagues.
- Excellent understanding of clinical development, quality and regulatory standards (e.g., CDISC) and risk-based data management approach (e.g., GCP, ICH).
- May require certification in assigned area.
Knowledge/Skills/Abilities:
- Ability to develop technical and/or business solutions to complex problems.
- Strong analytical and business communication skills.
- Ability to identify, author, maintain, and train staff on key data management SOPs and work-practice guidelines.
- Knowledge of Good Clinical Practices (GCP) essential.
- Demonstrated success managing data management activities of Clinical Research Organizations (CROs).
- Exercises independent judgment; builds formal cross-group networks.
Benefits:
- Base pay range: $232,000–$330,000 annually.
- Comprehensive Total Rewards benefits (401k with company contributions, medical/dental/vision, life/disability, flexible spending accounts), discretionary annual bonus (or sales incentive for field sales), company stock purchase/long-term incentives, vacation/paid holidays, sick days.
Application instructions:
- Not provided in the text.
- Provide strategic and operational leadership for Clinical Data Management (CDM) activities across clinical studies Phase I–IV (internal FTEs, FSP resources, and fully outsourced studies across geographies).
- Lead assigned clinical programs as a key member of the CDM Senior Leadership Team.
- Drive development of CDM capabilities and shape organizational structures across a growing, complex functional portfolio.
- Lead and coach employee development (including Director-level individuals); manage recruiting and training within departmental scope.
- Represent CDM in cross-functional discussions and step in for Head of CDM as needed; collaborate closely with senior R&D and matrix leaders.
- Align with Business/Functional/TA heads on portfolio objectives to influence CDM strategy and ensure quality, efficient, and compliant CDM deliverables.
- Manage CDM workload and ensure appropriate resource allocation (including vendor engagement/utilization).
- Continuously develop and adjust innovative operating models; improve productivity and effectiveness.
- Lead departmental process development/optimization and sponsor initiatives driving change within/across functions.
- Engage cross-functional senior leadership to deliver solutions for new service capabilities.
- Contribute to performance metrics and identify ways to raise standards; ensure team adherence to standards and compliance.
- Attract and retain top talent; ensure effective, transparent communication and an engaged, empowered environment.
Supervisory Responsibilities:
- Directly and indirectly supervise employees.
- Responsible for growth and development of Director-level and below employees.
Qualifications / Experience / Education:
- BS/BA + 15+ years; or MS/MA + 13+ years; or PhD + 12+ years; or equivalent combination.
- Typically 17+ years related experience (or combination of education/training).
- Required: Biotech/Pharmaceutical industry; demonstrated leadership of global data management teams; experience participating in regulatory submissions and inspections; minimum 10 years line management.
- Required: Extensive people leadership (talent development and performance management) for a Clinical Data Management organization.
- Preferred: Oncology clinical trials experience; leading major change initiatives; experience developing Director-level colleagues.
- Excellent understanding of clinical development, quality and regulatory standards (e.g., CDISC) and risk-based data management approach (e.g., GCP, ICH).
- May require certification in assigned area.
Knowledge/Skills/Abilities:
- Ability to develop technical and/or business solutions to complex problems.
- Strong analytical and business communication skills.
- Ability to identify, author, maintain, and train staff on key data management SOPs and work-practice guidelines.
- Knowledge of Good Clinical Practices (GCP) essential.
- Demonstrated success managing data management activities of Clinical Research Organizations (CROs).
- Exercises independent judgment; builds formal cross-group networks.
Benefits:
- Base pay range: $232,000–$330,000 annually.
- Comprehensive Total Rewards benefits (401k with company contributions, medical/dental/vision, life/disability, flexible spending accounts), discretionary annual bonus (or sales incentive for field sales), company stock purchase/long-term incentives, vacation/paid holidays, sick days.
Application instructions:
- Not provided in the text.