Back to jobs
New

Associate Director, Clinical Scientist

South San Francisco, California, 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 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:  Associate Director, Clinical Scientist

Department: Clinical Development

Reports To: VP, Clinical Development Lead (CDL) for each program

 

Job Overview

The Associate Director, Clinical Scientist will play a critical role in the analysis and monitoring of research study data, in all phases of development for company-developed assets in cardiovascular disease, and in support of phase 2B and large phase 3 clinical trials. This role will report to the VP, Clinical Development Lead (CDL) for each program and will collaborate closely with colleagues on the program governance team (e.g., Global Program Team) from clinical development, clinical operations, data management, statistics, regulatory, medical affairs, and pharmacovigiliance. The Associate Director, Clinical Scientist will be instrumental in providing comprehensive clinical trial data reviews, interpreting complex data sets, and creating high-impact scientific content to progress Kardigan’s clinical programs and trials.

Essential Duties and Responsibilities

  • Partner with VP-CDL and the broader cross-functional governance team members from the Global Project Team (GPT) and the Clinical Strategy Team (CST) in the planning and execution of clinical research studies.
  • May function as Lead Clinical Scientist for a program driving the development, planning, and execution of clinical studies. This includes the development of clinical study documents such as study protocols, amendments, statistical analysis plans, and clinical trial site/patient-facing materials.
  • Ensures the quality and scientific integrity in the monitoring and interpretation of study data of a clinical development program.
  • Maintains proficient understanding of therapeutic disease area(s) and drug candidates including underlying disease biology, and up-to-date knowledge of relevant scientific literature, therapeutic area trends, and regulatory requirements impacting clinical trials and drug development.
  • Exhibits strong analytical knowledge and skills to understand how study objectives and design impact data analysis; supports identification and/or identifies critical risks and mitigations
  • Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
  • Partnership with data management, statistics, and drug safety teams to integrate pharmacokinetic, clinical efficacy, and safety data into overall clinical study designs.
  • Develops the Expanded Protocol Synopsis and authors clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments.
  • Authors and/or reviews documents related to trials, such as medical monitoring and data monitoring plans, statistical analysis plans, informed consent forms, and clinical components of the Clinical Study Reports and supports the development of regulatory documents while ensuring adherence to Good Clinical Practices (GCP).
  • Supports Data Monitoring Committees, Safety Review Committees, or other applicable data review committees with committee charter development, preparing updates and data reviews, facilitation of meetings, and communication of synthesized data reports.
  • Provides support for review of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, visualizing, interpreting, and summarizing data reports

 

Qualifications and Preferred Skills

  • Advanced degree or equivalent education/degree in life science/healthcare (PhD, MD, PharmD) preferred with 5+ years of pharmaceutical drug development experience in the biopharmaceutical/biotechnology industry
  • Familiarity with clinical trial design principles, clinical trial operational execution, and regulatory requirements (e.g., FDA, EMA).
  • Strong understanding of biostatistics and experience in interpreting clinical trial data
  • Proficiency in medical writing and developing high-quality scientific documents.
  • Familiarity with Good Clinical Practices (GCP) and experience in ensuring compliance with GCP guidelines in scientific writing and publication.
  • 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 therapeutic area preferred

Exact Compensation may vary based on skills, experience and location.

Pay range

$190,000 - $240,000 USD

Create a Job Alert

Interested in building your career at Kardigan? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Kardigan’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.