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:  Senior Director / Medical Director – Clinical Trial Lead

Department:  Clinical Development

Reports To:  Vice President, Clinical Development Lead

Location: South San Francisco, CA or Princeton, NJ – On-site 3-4 days per week

Job Overview

The Senior Director / Medical Director - Clinical Trial Lead will be a physician with extensive drug development expertise who

will be expected to lead to the clinical development strategy for the phase 1-3 clinical trials of the program, including the

protocol design, operational planning and trial execution, medical and safety monitoring, trial close out, trial results

interpretation, and preparation for dissemination of the trial results, working with academic partners.

Essential Duties and Responsibilities

Leads the aforementioned clinical activities for the phase 1-3 trials for the program as a key member of the Clinical Strategy

Team, that is embedded within the Global Project Team, including taking primary responsibility for medical monitoring, data

monitoring, and safety monitoring for the clinical development function

Provide clinical/scientific knowledge into the development, design, delivery, and communication of the global evidence

generation plan, working closely with Medical Affairs colleagues

Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the

development program

Takes primary responsibility for the clinical development function, working with statisticians, modelers, and project

team-members, for contributing to the creation of trial-specific statistical analysis plans, and for the interpretation,

reporting, and dissemination of the final results, working closely with academic partners

Contributes to and provides oversight of the operational aspects of study conduct including site selection and activation, site

investigator and staff training, site start up and activation, screening and recruitment of trial participants, and trial

close-out activities

Leads the authoring and review of clinical parts of regulatory submissions, regulatory briefing documents, Investigational

Brochures, scientific disclosures of trial results, and other relevant documents.

Leads clinical responses to regulatory or IRB/Research Ethics Committee for information requests.

Works with Key Opinion Leaders to incorporate their input into trial protocol designs, clinical development plans, clinical

trial site selection, and regulatory interactions

Ensures consistency of clinical content and scientific messages across abstracts, publications, and other external documents

Contributes to the TPP (target product profile) and Global Product Safety (GPS) plans

Give scientific presentations at advisory boards, trial academic committees, key scientific meetings, and other venues

Qualifications and Preferred Skills

MD, or equivalent medical degress is required, and cardiology specialty training and cardiology board certification strongly

preferred

Minimum 10 years’ clinical development experience working cross-functionally in the regulated medical products industry

is required.

Experience designing and running Phase 1-3 trials, experience with preparation of and submissions of INDs

and NDAs also preferred

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.

Collaboration/Relationship Management: 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.

Influencing: Demonstrated ability to lead a matrixed team through influence. Proven track record of influence strategy,

initiative(s) implementation, and decision-making. Proactively influences and motivates others to achieve objectives.

Decision Making: Strong decision-making skills taking multiple perspectives into account and analytical skills are required;

exercises sound business judgment that has broad organizational impact.

Communication: Excellent communication skills (both orally and written) is critical to the success of the role.

Business Excellence: Good at developing the processes necessary to get things done, knowing how to organize people and

activities, and knowing what to measure and how to measure. Demonstrated ability to interpret data into actionable items

Negotiation: Proven negotiation skills that effectively drive discussions and decisions to desired end results that have broad

organizational impact.

Alignment: Proven track record of achieving alignment with internal and external stakeholders

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

Pay range

$242,000—$347,000 USD

Role

Senior Director/Medical Director, Clinical Trial Lead

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