Sr Director, Biomarkers Lead

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: Head of Biomarkers

Department: Development

Reports To: Chief Medical Officer

Job Overview

Kardigan is seeking an experienced leader and collaborator to join its translational medicine team as the Biomarkers (Senior Director, or Executive Director). We are seeking a Biomarkers lead who can help guide Kardigan’s selection of therapeutic interventions to improve patients’ lives.

The biomarker team will be responsible for working with other members of the R&D organization to define and implement clinical measurements of patient profile, drug action and the potential for disease modification. In addition, this team will work with colleagues in nonclinical pharmacology to develop exploratory markers in preclinical studies that could be transferred with the clinic. A passion to understand the causal biology of cardiac disease is essential. 

The Head of Biomarkers will build an integrated in-house team capable of developing and transferring appropriate bioassays to contract research labs for use in clinical studies.  This team will also work closely with Clinical Operations to ensure that all patient samples are collected, stored, and annotated in an appropriate manner.  The Head of Biomarkers will also collaborate closely with Clinical Pharmacology and Computational Biology to develop new insights to guide patient stratification, the selection of exploratory markers, and the identification of new mechanisms to address residual patient need.

Essential Duties and Responsibilities

The successful candidate will:

• Build and develop the internal biomarker team
• Define the bioanalytical support needed to support Kardigan’s biomarker efforts and develop the proposed balance between in-house and out-sourced operations
• Hire and manage the in-house bioanalytical team
• Within the first year, identify other scientific resources (including a succession strategy) needed for the biomarker group
• Work closely with Kardigan’s clinical operations team to ensure appropriate sample capture, management, storage and annotation
• Identify preferred contract labs for biomarker measurements and assist in vetting their operations as needed
• When needed, help design and implement training on sample management, etc. for clinical sites
• Contribute to core development team budgets
• Collaborate with colleagues in Early Development to design mechanistically driven criteria for patient selection and proof-of-concept go/no-go decisions
• Work closely with biostatistics to integrate and interrogate biomarker data in the context of clinical information.  Lead collaborative, iterative analyses of these data "pivots" to further elucidate disease pathobiology and drug mechanism-of-action
• Collaborate with colleagues in Early Development to leverage this information and develop clinically testable hypotheses.
• When needed, propose and support preclinical studies that could help test these criteria
• Collaborate with colleagues in Research to help identify new programs for Kardigan’s pipeline based on patient response to current therapy and residual medical need
• Share the evolving vision and progress of the biomarker team with management and potential advisory groups

Qualifications and Preferred Skills

• A PhD in biology or MD. While familiarity with muscle biology or cardiovascular disease is strongly desired experiences in chronic human diseases in immunology, metabolic diseases, or oncology are also acceptable.
• A minimum of 10 years of translational in the pharmaceutical and biotechnology industry.
• The ideal candidate will have contributed to programs that have used biomarker data to make critical go/no-go decisions on project advancement and/or patient stratification
• A track record of developing people with an emphasis on building collaborative, high-performing teams
• High energy, with a passion for fundamental disease understanding, quality drug development, and entrepreneurial spirit.
• Ability to thrive in a fast-paced, innovative environment.
• Strong problem-solving capacity - enjoys complex challenges and has the accountability to deliver on ambitious, but realistic, business, and scientific goals.
• Excellent communication skills – ability to communicate science clearly and effectively to a broad range of audiences including non-specialists.
• Ability and interest to serve as a teacher and mentor to others in the company