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Director, Clinical Operations Process & Strategic Planning

South San Francisco, California, United States, Princeton, New Jersey, United States

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 our mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. 

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: Director, Clinical Operations Process & Strategic Planning (Sr. Director-level candidates welcome to apply) 

Department: Development 

Reports To: Sr. Director, Development Operations 

 

Job Overview 

The Director, Clinical Operations Process and Strategic Planning will play a pivotal role in driving the success and operational efficiency of Clinical Operations. This role will be responsible for the assessment, planning, and implementation of global processes, strategies and solutions to ensure Clinical Operations is prepared to implement and execute multiple global late phase studies. This role will perform an analysis of current clinical operations processes, systems, vendors, and infrastructure to ensure the organization can seamlessly execute multiple global late phase trials across multiple indications. This role reports to the Sr. Director, Development Operations and will be a key leader on the Clinical Operations Leadership Team, helping shape the Clinical Operations strategy, and ensuring the vision for excellence is effectively communicated and implemented. The ideal candidate will be an analytical and proactive individual with a proven ability to translate data into actionable insights, collaborate effectively across departments, and thrive in a dynamic, fast-paced environment. 

 

Essential Duties and Responsibilities 

  • Strategically lead efforts related to ensuring clinical operations is set up from a people, process, vendor, and technology perspective to effectively execute on multiple global Phase 3 studies. 
  • Conduct gap analyses; identify potential risks to clinical operations related trial readiness; operationalize mitigation strategies in collaboration with key stakeholders/leadership. 
  • Strategically evaluate and implement solutions to address any operational geographic gaps related to ensuring clinical operations delivery teams are set up for optimal study execution. 
  • Optimize current state clinical operations processes to ensure Phase 3 operations are seamless particularly as it relates to study startup, vendor strategy, study conduct, and clinical participation in data review. 
  • Partner with the Clinical Operations Program Lead(s) to provide executive updates on Clinical Operations Phase 3 readiness progress to leadership and other key stakeholders, including key milestones, risks, and overall strategy. 
  • Communicate future state strategies to leadership and clinical operations delivery teams. 
  • Support organizational change management efforts for Clinical Operations ensuring a seamless transition to planning and conducting large late phase clinical trials. 
  • Support the strategic development of centralized clinical trial recruitment strategies to support Phase 3 trials, including vendors and platforms to support the enrollment of diverse patient populations.

  • Provide strategic input into clinical operations, clinical compliance, inspection readiness, and submission related initiatives. 
  • Provide strategic expertise and facilitate leadership alignment of cross functional SOPs. 
  • Effective partnership and collaboration with cross functional leaders/stakeholders (e.g. Project Management, Biometrics, Quality, Legal, Regulatory) as it relates to planning, interdependencies, and risk mitigations relative to Phase 3 readiness and trial conduct. 

 

Qualifications and Preferred Skills 

  • Minimum 15 years of pharmaceutical/biotech industry experience in Clinical Operations. 
  • Bachelor’s degree required, advanced degree desirable. 
  • Extensive experience in operationalizing global Phase 3 clinical trials and inspection readiness/preparedness. 
  • Experience leading Clinical Compliance and/or other Clinical Process functions. 
  • Experience as an active contributor to a submissions team with experience resolving findings from real and mock heath agency inspections. 
  • Minimum 10 years of people leadership experience, with a proven track record of building effective teams and driving innovation in clinical trial optimization. 
  • Ability to understand and synthesize complex issues into strategic solutions and implementation plan. 
  • Deep understanding of the clinical trial landscape and commitment to efficiency, innovation, and operational excellence. 
  • Excellent leadership, communication, and interpersonal skills, with the ability to influence and build relationships across functions at all levels of the organization. 
  • Extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, and major Health Authority regulations. 
  • Strong project management skills, effective leadership, and the ability to hold teams accountable for deliverables. 
  • Ability and thrive in a fast paced, dynamic environment. 
  • Availability to participate in calls across multiple time zones. 
  • Position requires up to 30% travel. 

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