Kardigan

Kardigan

Senior Director, Clinical Lead

Princeton, New Jersey, United States · Director

Sponsorship not specified$242k-$337kDetected 27 days ago
Data AnalysisBudgetingContract ManagementClinical TrialsClinical ResearchResearchCommunication

About the role

  • 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.
  • These values are the foundation of our work, empowering us to make a real difference, every day.

Responsibilities

  • Senior Director, Clinical Lead
  • Leads Clinical activities and is a key member of the Global Project Team.
  • In charge of strategy and planning clinical development of phase 1 to phase 3 and post launch study protocols, amendments, and other clinical research related documents and study reports
  • Provide clinical/scientific knowledge into the development, design, delivery, and communication of the global evidence generation plan
  • Leads the clinical part of the submission dossier in regulatory filings dossiers, and updates, regulatory briefing documents, Investigational Brochures, and other relevant documentation
  • Leads the clinical strategic planning, authoring and review of clinical parts of regulatory submissions and scientific data disclosures of the studies.
  • Works with external and internal Key Opinion Leaders to help identify and validate new drug targets and related biomarkers

Requirements

  • MD., or another health sciences area (e.g.: PharmD) is required.
  • Minimum 5 years' clinical development experience working in the regulated medical products industry is required.

Compensation

  • $242k-$337k

Benefits

  • Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
  • Leads clinical medical responses to regulatory or IRB/Research Ethics Committee information requests.

Company info

  • 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 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.
  • Position Title: Senior Director, Clinical Lead
  • Reports To: Vice President, Global Program Head
  • Job Overview
  • The Senior Director, Clinical Lead will be expected to lead to the clinical strategy, planning and execution for key aspects of clinical development of the program.
  • Direct responsibilities include working with Global project team to identify the best clinical study that will provide the target product profile that was developed, planning and executing all activities related to the clinical trials of the program and that may also include other activities such as publication of study results and presentations.
  • Essential Duties and Responsibilities
  • Interpret and communicate clinical trial data
  • Takes primary responsibility, working with statisticians, modelers, and project team-members, for study data analysis and interpretation, reporting and communication
  • Assists and provides oversight with the operational aspects of study conduct including site selection and activation, site investigator and staff training, budget planning and contract review
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This listing is sourced directly from Kardigan's careers page and normalized into a canonical job model.