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Senior Director, Clinical Data Management
Location
California
Posted
1 day ago
Salary
$187K - $279.8K / year
Seniority
Senior
Job Description
Senior Director, Clinical Data Management
Akero Therapeutics
• Serve as a senior thought partner to functional leaders, contributing to program-level planning, risk mitigation, and execution strategies. • Collaborate across Clinical Operations, Biostatistics, Medical, Regulatory, Safety, and Quality to identify and resolve data-related issues impacting timelines, quality, or compliance • Set up data management vendors as required, including authoring of RFPs, reviewing and negotiating data management budgets and contracts • Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines to support program timelines • Oversee data review, cleaning, and database lock activities to ensure accuracy and readiness for analysis and regulatory submission • Proactively identify vendor risks, escalate issues as needed, and drive root-cause analysis and corrective actions • Balance quality, timelines, and cost while driving pragmatic solutions aligned with program priorities • Foster a culture of accountability, collaboration, and continuous improvement across internal teams and external partners • Provide direct supervision and periodic review of work for departmental employees, to ensure oversight and execution of clinical development timelines • Direct and mentor a team of data management professionals. • Foster a collaborative environment that encourages innovation and knowledge sharing. • Ensure effective resource allocation and management across research departments. • Drive performance and accountability through clear communication of expectations and goals • Support organizational growth by scaling data management capabilities and processes as the portfolio evolves
Job Requirements
- Bachelor's degree required; Master's degree in Life Sciences or a related discipline highly preferred.
- Minimum of 12 years of experience in clinical development within the pharmaceutical or biotechnology industry, including significant experience as a hands-on clinical data management lead. At least four years of management experience within pharmaceutical development is preferred.
- Strong understanding of drug development, FDA regulations, and ICH GCP guidelines, with thorough knowledge of the pharmaceutical industry and the conduct of global clinical studies.
- Demonstrated leadership and people-management experience, with a proven track record of leading cross-functional and international teams and influencing senior leaders across functions.
- Experience managing clinical data management vendors, contractors, and service providers to ensure delivery of program objectives and timelines.
- Strong analytical skills with demonstrated experience gathering, interpreting, and analyzing clinical research and drug development data to support decision-making and risk management.
- Excellent communication, presentation, and stakeholder-management skills, with the ability to translate complex data and risks into clear, business-relevant insights.
- Understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies required
Benefits
- medical, dental and vision coverage
- life insurance
- disability insurance
- 401(k) savings plan
- flexible spending accounts
- employee assistance program
- tuition reimbursement program
- voluntary benefits such as group legal
- critical illness
- identity theft protection
- pet insurance
- auto/home insurance
- time off pursuant to its sick time policy
- flexible vacation policy
- parental leave policy
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