Kardigan · 13 hours ago
VP, Head of Development Services
Kardigan is a heart health company focused on making cardiovascular disease preventable and curable. The Head of Development Services is responsible for building and overseeing the operational backbone for efficient and compliant clinical development, leading centralized development services, and ensuring consistency and quality across the development portfolio.
Artificial Intelligence (AI)BiopharmaHealth CareMedical
Responsibilities
Establish and lead centralized development services supporting all clinical programs
Build and lead development services organization, including Business Operations, TMF Management, and Vendor Relationship & Management functions and identifying functions scaled to meet the growing needs of the development portfolio
Own the TMF strategy & operating model, ensuring TMF completeness, inspection readiness, and regulatory compliance across development functions
Oversee the Business Operations function including Clinical Sourcing & Procurement and Contract & Budgets functions
Partner with Finance & Operations to forecast clinical development costs and optimize spend
Oversee end-to-end management of vendor and site contracts and oversight of forecasts, accruals, and variance management
Establish comprehensive & scalable preferred vendor governance frameworks, including selection, contracting, performance management, and oversight aligned with portfolio needs
Drive competitive RFP processes, vendor selection, rate cards, and negotiation strategies
Partner with Quality to address vendor audits, CAPAs and compliance issues
Drive standardization of processes, metrics, and reporting across development
Provide portfolio-level operational insights to support executive and Board decision-making
Ability to assess and transform capabilities through AI and Automation solutions or strategies
Develop and lead a high-performing development services organization
Up to 20-30% domestic and international travel, as required
Qualification
Required
Bachelor's degree in life sciences, business, or related field
15+ years of experience in development operations leadership, development services, or related roles
Or advanced degree (PhD, MBA, Masters) and 12+ yrs of experience
Proven experience building centralized operational functions in biotech or pharma
Strong vendor governance, TMF, and operational excellence background
Strong Understanding of global clinical trial operations and regulatory requirements
Experience supporting multiple phases of development, including late stage registrational trials
Strategic sourcing & negotiation expertise
Strong Financial Acumen & budget management
Deep understanding of vendor governance, performance, and inspection management
Executive-level communication and stakeholder management
Ability to scale to meet the needs of the business and portfolio
Company
Kardigan
Kardigan develops personalized medicines using AI and data to target and treat the root causes of cardiovascular diseases.
Funding
Current Stage
Growth StageTotal Funding
$554M2025-10-14Series B· $254M
2025-01-10Series A· $300M
Recent News
2025-12-16
2025-11-19
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