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VP, Head of Development Services

Princeton, New Jersey

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 Giannakakos, Jay Edelberg, M.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.
 
 

Role Summary 

The Head of Development Services is responsible for building and overseeing the operational backbone that enables efficient, compliant, and scalable clinical development. The role leads centralized development services—including Business Operations, Trial Master File (TMF) Management, and Vendor Relationship & Management—ensuring consistency, transparency, and quality across the development portfolio.  The role is a member of the Development Operations & Biometrics leadership team, and as such, participates in senior leadership meetings and strategic initiatives across the development organization.  

Key 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. 

Qualifications & Preferred Skills 

  • 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 
     

 

 

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