Senior Manager, Clinical Scientist (Contract to Hire)

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: Senior Manager, Clinical Scientist (Contract to Hire) 

Department: Development 

Reports To: Executive Director, Clinical Lead 

Job Overview 

The Clinical Scientist will play a critical role in the analysis of research study data, in all phases of development for company-developed assets as well as competitor drugs in the cardiovascular therapy area. This role will report to the Clinical Lead and collaborate closely with colleagues on the Global Program Team for clinical development, clinical operations, data management / statistics, regulatory, commercial, medical and drug safety topics. The Clinical Scientist will be instrumental in interpreting complex data sets, creating high-impact scientific content, and representing the GPT as needed in both internal and external interactions. 

Essential Duties and Responsibilities 

• Collaborate with the DLL, the Clinical Lead, and the broader GPT in the planning of clinical research studies.
  
  
• Work closely with data management, statistics, and drug safety teams to integrate pharmacokinetic, clinical efficacy, and safety data into overall clinical study designs.
  
  
• Provide analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
  
  
• Provide outputs that may be incorporated into documents such as investigator brochures, clinical study reports, and other regulatory documents.
  
  
• Conduct data reviews of clinical data sets and participate in statistical analyses in collaboration with biostatisticians.
  
  
• Develop data visualization strategies to effectively communicate clinical trial data and outcomes.
  
  
• Provide organizational support for Data Monitoring Committees, Safety Review Committees, or other applicable data review committees including operationalizing the charter, preparing updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
  
  
• Contribute to the preparation and submission of manuscripts for publication in peer-reviewed journals, ensuring adherence to Good Publication Practices (GPP).
  
  
• Support the development of clinical study documents, including study protocols, and patient-facing materials.
  
  
• Maintain up-to-date knowledge of relevant scientific literature, therapeutic area trends, and regulatory requirements impacting clinical trials and drug development.

Qualifications and Preferred Skills 

•  Advanced degree (MD, PhD, PharmD, DMP; MS with additional direct experience) in a life sciences or health-related field strongly preferred.
  
  
• 5+ years of experience in clinical operations, clinical development, medical affairs, or regulatory affairs, preferably within the biopharmaceutical or biotechnology industry and/or first-hand experience working at a clinical research site on human trials.
  
  
• Familiarity with clinical trial design, execution, and regulatory requirements (e.g., FDA, EMA).
  
  
• Strong understanding of biostatistics and experience in interpreting clinical data.
  
  
• Proficiency in medical writing and developing high-quality scientific documents.
  
  
• Familiarity with Good Publication Practices (GPP) and experience in ensuring compliance with GPP guidelines in scientific writing and publication.
  
  
• Experience with Microsoft Excel and presentation software (e.g., PowerPoint).
  
  
• Proven ability to create and generate scientific presentations for consumption by diverse audiences.
  
  
• Excellent organizational, interpersonal, and communication skills.
  
  
• Must be willing and possess the expertise to work effectively in a fast-paced, team-based matrix environment as well as the ability to function independently as appropriate. Flexible to accommodate changes in team and project needs.
  
  
• Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.
  
  
• Experience in the Cardiovascular therapy area strongly preferred.