Senior Director/Medical Director, Clinical Trial Lead

Kardigan•Princeton, NJ

8d•$242,000 - $347,000•Hybrid

About The Position

Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. The company aims to develop targeted treatments for cardiovascular diseases. Kardigan is led by experienced individuals who previously led MyoKardia to develop mavacamten. The company possesses a strong discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team focused on improving patient lives. Kardigan's values emphasize patient-centricity, authenticity, continuous learning, teamwork, and enabling innovation through risk-taking.

Requirements

MD, or equivalent medical degrees is required.
Minimum 10 years’ clinical development experience working cross-functionally in the regulated medical products industry is required.
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.
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.
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.

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.
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.
Demonstrated ability to interpret data into actionable items.

Responsibilities

Leads clinical activities for phase 1-3 trials for the program as a key member of the Clinical Strategy Team, embedded within the Global Project Team.
Takes primary responsibility for medical monitoring, data monitoring, and safety monitoring for the clinical development function.
Provides clinical/scientific knowledge into the development, design, delivery, and communication of the global evidence generation plan, working closely with Medical Affairs colleagues.
Supports cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program.
Works 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.
Gives scientific presentations at advisory boards, trial academic committees, key scientific meetings, and other venues.