Back to jobs
New

Director, Non-Clinical Development & Translational Sciences

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 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.
 
 

Position Title: Director, Non-Clinical Development & Translational Sciences

Department: Translational Sciences

Reports To: VP, Research & Translational Sciences

Location: South San Francisco, CA – On-site 4 days per week (Mon to Thurs)

 

Job Overview

The Director of Non-Clinical Development, under the umbrella of Translational Sciences, is a strategic role at Kardigan that will oversee the design, execution, and reporting of Kardigan’s nonclinical regulatory strategy. The incumbent will provide strategic leadership and oversight for non-clinical safety and toxicology assessments over the various stages of the drug development process from early discovery (IND planning) to late stages of clinical development up to approval.

 

Essential Duties and Responsibilities

  • Oversee the development and execution of an integrated non-clinical regulatory strategy, serving as lead for all aspects of non-clinical development at Kardigan
    • Design, execute, and oversee the in vitro/in vivo toxicology and safety pharmacology strategies, following (or exceeding) established guidelines/requirements
    • In collaboration with research and development team leaders, participate in the budgeting, prioritization, staffing, and management of non-clinical development programs.
    • Evaluate, select, monitor, and manage Contract Research Organizations (CROs), including risk assessment and management.
    • Drafting of study protocols, and peer review of studies and reports, until finalization, leading interpretation of data and oral/written communication of results
    • Support integrated development plans, regulatory submissions, and approvals through the timely provision of data and its analysis. Be accountable for nonclinical sections/contribution to INDs, Investigational Brochures, Regulatory Briefing Documents, and other relevant documentation for assigned programs
    • Partner with relevant members of research, discovery, CMC, quality assurance, and development to deliver program studies on time and in budget
    • Ensure consistency of non-clinical content and messages across scientific and non-scientific publications and materials
    • Hire, manage, and/or supervise a team of non-clinical scientists, consultants, and collaborator
  • Serve as representative of the non-clinical function, and/or assign adequate designates, to project teams, and/or regulatory meetings
  • Support the evaluation of safety assessment candidates, and the selection of development candidates
  • Provide technical support to various departments within the company with respect to non-clinical development, including safety pharmacology and toxicology. Partner with relevant groups and departments to incorporate innovative technology and state-of-the art scientific knowledge/tools, including imaging, biomarkers, genetic, and multi-omic analyses (to name a few), to leverage non-clinical studies to accelerate the translational understanding of diseases and mechanisms of action for agents under development.
  • Assist in the development, adherence, and optimization of departmental, project, and corporate budgets.
  • Develop relevant Standard Operational Procedures (SOPs)

 

Qualifications and Preferred Skills

  • DVM, MD, and/or PhD in a relevant discipline, with a minimum of 7 years of non-clinical development experience in the CRO and/or biotechnology/pharmaceutical industry.
  • Demonstrable pathology training and expertise, as well as diplomate status in appropriate organization (SOT, SPS, ACVP, ECVP, ABP, etc.) is highly desirable.
  • Expert understanding of Nonclinical drug development, ideally with relevant cardiovascular (CV) therapeutic area and demonstrable multi-modality experience
  • Expertise in safety pharmacology and toxicology as well as study design principles meeting GLP/ICH requirements, and other Regulatory considerations, as they pertain to various therapeutic modalities (small molecules, ASOs, mRNAs, etc.)
  • Leadership: Experience leading and motivating teams in a matrix environment is required. Proven interpersonal skills with ability to influence, resolve conflict and drive decisions among internal cross functional teams, executive management, and external teams.
  • Strategic Agility: Ability to develop and execute complex strategies.
  • Ability to effectively collaborate in and across multiple functions, and with internal and external stakeholders of various backgrounds and skill sets. Skilled in establishing a collaborative and respectful environment.
  • Demonstrated decision-making skills taking multiple perspectives into account and analytical skills are required; exercises sound business judgment that has broad organizational impact. Publication supporting these skills are a plus.
  • Communication: Excellent communication skills (both orally and written) is critical to the success of the role.
  • Business Excellence: Track record of establishing business processes necessary to accomplish goals on time and in budget, demonstrable experience managing and organizing projects, people, resources, and activities, and knows what to measure and how to measure. Demonstrated ability to interpret data and project needs into actionable experiments and results.

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

Pay range

$210,000 - $273,000 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.