Job Title: Global Head of Clinical Data and Business Strategy
Location: Morristown, NJ or Cambridge, MA
Main responsibilities include: Clinical Data Technology Leadership:
- Partner with clinical development teams to ensure seamless data flow and study execution across therapeutic areas
- Collaborate with the Global Head of AI-Driven Innovations to develop and execute a comprehensive strategy that revolutionizes traditional clinical data processing through AI-powered solutions
- Enable real-time access to clinical data from increasingly diversified sources, reimagining data management with a complex, multi-disciplinary approach to data quality and intelligence generation
- Define and execute the strategic roadmap for AI-powered clinical data flows, leading process optimization initiatives that enhance efficiency and data quality
- Establish and maintain reinforced governance frameworks for system validation, change management, quality assurance, and regulatory compliance
- Drive standardization and innovation in clinical database design aligned with CDISC standards and regulatory requirements
Embracing increasingly diversified patient data sources: - Partner with Procurement, Digital, and Vendor Excellence teams to develop and execute strategic partnerships with technology providers, CROs, and academic institutions
- Lead initiatives to enable real-time access to eHR data, patient-generated data from wearables, mobile health applications, and other emerging sources
- Evaluate and integrate innovative data collection methodologies that enhance patient engagement and data richness
- Ensure data interoperability and integration across traditional and novel data sources
Business Strategy Leadership:
- Define and execute comprehensive business strategy and robust sourcing strategies in the highly dynamic digital transformation environment
- Represent CDAIP in cross-functional strategic planning and enterprise-wide digital transformation initiatives
- Drive thought leadership through industry conferences, publications, and collaborative forums
- Establish and maintain relationships with regulatory agencies, industry consortia, and external partners
Team Leadership:
- Foster a culture of innovation, continuous learning, improvement, and technical excellence within the Clinical Data Technology & Business Strategy team
- Provide strategic direction, mentorship, and career development for diverse, high-performing teams
- Promote a collaborative work environment that encourages creativity, problem-solving, and cross-functional partnership
Stakeholder Management:
- Collaborate with senior leadership to align department goals with overall company strategy and Play to Win objectives
- Partner with Clinical Operations, Digital, EGDS, Regulatory, Vaccine teams to ensure seamless integration of AI and data processing solutions into existing workflows
- Build strong relationships across functions, geographies, and organizational levels
Compliance and Ethics:
- Ensure all AI and data processing activities comply with relevant regulations, ethical standards, and industry best practices (FDA, EMA, ICH-GCP)
- Develop and maintain robust data governance, privacy, and security protocols related to AI and advanced analytics
- Stay informed about evolving regulations and industry standards related to AI in healthcare and clinical development
- Champion responsible AI practices and ethical data stewardship across the organization
- Lead risk management strategies for data integrity, patient privacy, and regulatory compliance
About YOUBasic Qualifications:- Advanced degree (Master's or PhD) in Life Sciences, Computer Science, Data Science, Biostatistics, or related field. Candidates with a Bachelor's degree AND extensive leadership experience may also be considered.
- 10+ years of progressive experience in leadership roles within clinical development, data management, biostatistics, AI, or related fields in the pharmaceutical or healthcare industry
- Extensive expertise in clinical data management and analytics throughout the clinical development lifecycle
- Strong knowledge of clinical database design, data management planning, and CDISC standards (SDTM, ADaM, CDASH)
- Deep understanding of clinical trial processes, regulatory requirements (FDA, EMA, ICH-GCP), and data governance principles
- Proven track record of leading transformational change and driving innovation in complex, global organizations
- Excellent leadership, communication, and interpersonal skills with the ability to inspire teams and influence stakeholders at all levels
The salary range for this position is:
$232,500.00 - $335,833.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
