Back to jobs

Senior Director, Drug Substance Development

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 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: Sr. Director Drug Substance Development

Department: Technical Operations

Reports To: VP Head of DS Development

 

About Us

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. 

 

4 day on-site M-Th

Role Overview

Kardigan is seeking an experienced and accomplished Senior Director of CMC Drug Substance Development. Reporting directly to the VP of Chemical Development, this candidate will oversee the development of a growing early‑stage pipeline and a complex late‑stage portfolio across small molecules and oligonucleotides.

This role is responsible for ensuring the  end‑to‑end API development — from route design through commercial readiness across the portfolio of small molecule candidates, — and for providing technical, strategic, and operational leadership across all internal and outsourced development and manufacturing activities, ensuring deliverables are met.

 

Key Responsibilities

Chemical & Process Development

  • Technical lead for programs. Ensuring programs move smoothly through development from early phase to late phase, file and launch.
  • Technical lead for route selection, process optimization, scale‑up, technology transfer, validation, and manufacturing strategy for all drug substance programs.
  • Ensure processes are designed to meet quality, yield, cost, and scalability targets appropriate for each development stage.
  • Develop and manage phase‑appropriate plans for process development, manufacturing, and supply.
  • Oversee and provide technical governance for all CDMO/CMO‑executed activities.
  • Provide support and guidance to other members of the Tech Ops department

Quality, Regulatory & Technical Documentation, including

  • Batch release activities
  • Establish drug substance specifications and stability programs in partnership with Analytical, Quality, and Regulatory functions.
  • Author and review CMC documentation for regulatory submissions, including protocols, reports, and Module 3 sections.
  • Support investigations, deviations, and root‑cause analyses to ensure robust scientific and operational outcomes.
  • Lead technical trouble shooting activities and ensure appropriate technical solutions are implemented.

Cross‑Functional Collaboration

  • Partner closely with Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Supply Chain, and Legal to ensure aligned execution across the development lifecycle.
  • Support inspection readiness and interactions with global health authorities.
  • Work with Procurement and Legal teams to negotiate and manage contracts governing outsourced development and manufacturing.

Strategy, Planning & Risk Management

  • Maintain awareness of evolving regulatory expectations and state‑of‑the‑art manufacturing technologies.
  • Assess CDMO capacity, supply chain risks, and inventory vulnerabilities and present effective solutions to executive leadership.
  • Support strategic planning for drug substance sourcing, technology strategy, and long‑term capability development.
  • Oversee contract deliverables and ensure operational alignment with Kardigan’s business objectives.

 

Qualifications & Preferred Experience

  • BS and MS/PhD in Organic Chemistry, Chemical Engineering, or a related scientific discipline
  • 15+ years of experience in the development of assets, spanning early‑ and late‑stage development.
  • Expertise in small molecule and preferably oligonucleotide product development.
  • Experience in leading the development of mid Phase and late phase assets
  • Demonstrated experience taking drug substances from R&D through commercialization.
  • Strong knowledge of GMP, global regulatory expectations, and quality systems.
  • Direct experience with global regulatory submissions (IND, IMPD, NDA, MAA).
  • Proven leadership in process validation and continuous improvement initiatives.
  • Excellent communication and presentation skills, with the ability to partner effectively and work within cross‑functional teams.
  • Ability to operate with agility in a fast‑paced, matrixed, growth‑oriented environment.
  • Creative, solutions‑focused mindset with a track record of driving operational progress and scientific excellence.

 

 

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

Pay range

$229,000 - $298,000 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.