Senior Director/Medical Director, Clinical Trial Lead

Kardigan•Princeton, NJ

7d•Hybrid

About The Position

Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. The company aims to develop multiple targeted treatments to address cardiovascular diseases. Led by experienced co-founders who previously led MyoKardia, Kardigan utilizes a cutting-edge discovery and translational research platform with a pipeline of late-stage candidates. The company is driven by values such as patient focus, authenticity, eagerness to learn, teamwork, and enabling the impossible. This role is crucial for leading the clinical development strategy for phase 1-3 clinical trials, encompassing protocol design, operational planning, execution, medical and safety monitoring, results interpretation, and dissemination, in collaboration with academic partners.

Requirements

MD, or equivalent medical degree is required.
Minimum 10 years’ clinical development experience working cross-functionally in the regulated medical products industry is required.
Experience leading and motivating teams in a matrix environment is required.
Strong decision-making skills taking multiple perspectives into account and analytical skills are required; exercises sound business judgment that has broad organizational impact.
Excellent communication skills (both orally and written) is critical to the success of the role.
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.
Proven track record of achieving alignment with internal and external stakeholders.

Nice To Haves

Cardiology specialty training and cardiology board certification strongly preferred.
Experience designing and running Phase 1-3 trials.
Experience with preparation of and submissions of INDs and NDAs also preferred.
Proven interpersonal skills with ability to influence, resolve conflict and drive decisions among internal cross functional teams, executive management, and external teams.
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 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.
Demonstrated ability to interpret data into actionable items.
Proven negotiation skills that effectively drive discussions and decisions to desired end results that have broad organizational impact.

Responsibilities

Lead clinical activities for phase 1-3 trials as a key member of the Clinical Strategy Team, embedded within the Global Project Team.
Take 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.
Take 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.
Contribute to and provide 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.
Lead the authoring and review of clinical parts of regulatory submissions, regulatory briefing documents, Investigational Brochures, scientific disclosures of trial results, and other relevant documents.
Lead clinical responses to regulatory or IRB/Research Ethics Committee for information requests.
Work with Key Opinion Leaders to incorporate their input into trial protocol designs, clinical development plans, clinical trial site selection, and regulatory interactions.
Ensure consistency of clinical content and scientific messages across abstracts, publications, and other external documents.
Contribute 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.