About Us
Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.
It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.
Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.
We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.
At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.
These values are the foundation of our work, empowering us to make a real difference, every day.
Position Title: Sr. Manager, IT Business Analyst, Development & Quality
Department: Information Technology
Reports To: Head of IT Business Partner & Solution Delivery
Location: Princeton, New Jersey (4 days per week onsite Mon – Thurs)
Position Summary
The Senior Manager, IT Business Analyst – Development & Quality is responsible for leading business analysis capabilities and serving as a strategic technology partner to Clinical Development, Regulatory Affairs, Pharmacovigilance/Safety and Quality organizations within a pharmaceutical company. This role ensures that business needs are translated into high-quality, compliant, and scalable technology solutions that support the end-to-end drug development lifecycle in a GxP-regulated environment.
Business Analysis Leadership
- Lead and oversee business analysis activities across Development‑related initiatives, including Clinical, Regulatory, Safety and Quality programs
- Establish business analysis standards, methodologies, and best practices aligned with SDLC and validation requirements
- Create / Review key analysis artifacts to ensure clarity, completeness, and regulatory readiness
- Act as escalation point for complex requirements, scope decisions, and cross‑functional dependencies
Stakeholder Partnership & Strategic Alignment
- Serve as a trusted IT partner to leaders:
- Develop a strong understanding of:
- Development & Quality strategies and portfolio priorities
- Global regulatory expectations and submission timelines
- Inspection and audit risk areas
- Partner with business stakeholders to shape demand into well‑defined, value‑driven initiatives
- Ensure alignment between Development & Quality priorities and IT roadmaps, architecture, and data strategies
Requirements & Solution Definition
- Lead end‑to‑end business analysis activities, including:
- Stakeholder interviews and facilitated workshops
- AS‑IS / TO‑BE process mapping
- Gap, impact, and risk analysis
- Elicit, document, and manage:
- Business, functional, and non‑functional requirements
- Data, reporting, and integration requirements
- Produce and govern high‑quality deliverables such as:
- Business Requirements
- Functional Specifications
- User Stories and Acceptance Criteria
- Process flows and data models
- Ensure requirements are clear, testable, traceable, and compliant with GxP and validation standards
Domain Enablement
- Support Clinical Development systems clinical integrations, and analytics platforms to ensure data integrity, operational transparency, and inspection readiness.
- Partner with Regulatory,Pharmacovigilance and Quality teams to support regulatory information management, submissions, safety case management, quality management systems and global reporting
- Identify and document use cases to leverage advanced technology solutions such as AI, to improve efficiencies in core business process
Governance, GxP Compliance & Risk
- Ensure all Development‑related IT solutions comply with:
- GxP principles
- 21 CFR Part 11 and Annex 11
- Internal SOPs and validation standards
- Partner closely with Quality and Validation teams to support:
- System impact assessments
- Validation planning and execution inputs
- Requirements Traceability Matrices
- Participate in audits and regulatory inspections as a IT representative
- Identify and proactively mitigate technology and data integrity risks
Delivery Support & Business Readiness
- Partner with Project Managers to support delivery execution
- Ensure requirements are effectively translated into design, build, and test activities
- Support UAT strategy, defect triage, and business sign‑off
- Drive business readiness activities including training, communications, and adoption planning
- Track and report on outcomes, benefits, and value realization
- Ensure post-project transition to support
Veeva-Centric Technology Stack
Hands-on knowledge of Veeva-centric ecosystem including Veeva Vault Clinical , Vault RIM, Vault Safety, Vault Quality, and Veeva CRM. The role ensures compliant configuration, integration, and data flow across Veeva platforms and adjacent clinical, regulatory, and safety systems.
Required Qualifications
Education
- Bachelor’s degree in Information Systems, Life Sciences, Computer Science, or related field
Experience
- 7+ years of experience in IT Business Analysis or related roles
- 5+ years supporting Pharma or Life Sciences clinical, regulatory, safety, quality organizations
- Demonstrated experience operating in GxP‑regulated environments
- Strong collaboration skills with internal IT team and external partners
Required Skills & Competencies
Core Competencies
- Strong leadership and stakeholder management skills
- Expert‑level business analysis and requirements management capability
- Ability to operate at both strategic and execution levels
- Excellent written, verbal, and facilitation skills
- Project management skills leading complex enterprise-wide system implementations
Technical & Domain Knowledge
- Strong familiarity with Development systems supporting:
- Clinical Development
- Regulatory
- Pharmacovigilance / Safety
- Quality
- Solid understanding of system integrations, data flows, and reporting architectures
- Experience working within validated system landscapes
Regulatory & Compliance
- Strong working knowledge of:
- GxP principles
- 21 CFR Part 11
- Data integrity and audit readiness
- Experience partnering with Quality and Validation teams