Director/Senior Director, Clinical Research
WFH Flexible Hybrid in Burlington MA or Remote
Description

Why join Cardurion Pharma?
At Cardurion, we are advancing the understanding of the cellular mechanisms that regulate heart function and are developing new treatments to address cardiovascular disease. Our programs seek to modulate signaling pathways that regulate heart cell function to reverse the pathophysiological mechanisms that drive cardiovascular disease. We invite you to explore our site to learn more about our Company and how we are advancing the promise of cardiovascular signaling pathways science to improve health and impact lives around the world.

The Role
Cardurion is seeking a biopharma physician-scientist to join a growing team and to engage in clinical research activities relating to development assets. This person will report directly to the Head of Clinical Research.  

Here’s What You’ll Do

  • Monitor ongoing and future clinical trials in partnership with clinical/ development operations and clinical research organization partners
  • Represent the clinical development functions on various cross functional teams
  • Collaborate on integrated development plans and work with support functions to ensure full integration of the development strategy for each asset
  • Author clinically-relevant sections of regulatory documents
  • Contribute to clinical trial protocol design and authoring activities (oversight of medical writer)
  • Co-authors manuscripts, abstracts, and when/ where possible present clinical research results at scientific congresses, including internally-organized events such as clinical and scientific advisory board meetings and clinical trial investigator meetings 
  • Participates in select data monitoring committee (DMC), safety review committee (SRC), and other clinical trial oversight committees, defined within clinical trial protocols.
  • In conjunction with development operations, drafts charters for oversight committees
  • Informs site selections and collaborations with key investigators
  • Tracks and ensures any concerns regarding study participant safety are addressed
  • Proactively addresses any topics that may impact clinical trial integrity 
  • Perform clinical review of data listings and essential study data within generated statistical reports (eg, SAS outputs) and other available data surveillance tools (eg, Spotfire, Rave) and partner with Data Management in generating relevant queries 
  • Liases among clinical trial innovators and Cardurion 
  • Support business development and investor relations activities

Here’s What We’ll Bring To The Table

  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), Delta Dental, and vision offered through VSP
  • Fully funded HSA for high-deductible PPO Plan
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 4 weeks Paid Time Off annually 
  • 401k (traditional and Roth offered) with 50% match on first 4% deferred. Match is vested immediately
  • A suite of Cardurion paid insurance coverage, including: life insurance, short-term and long-term disability
  • 10 company paid holidays and Year-End shut down 
Our Mission

Translate our world-class expertise in cardiovascular signaling pathways into groundbreaking therapeutics for patients.

Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. 
Requirements

Here’s What You’ll Bring To The Table 

  • MD, DO (or equivalent degree(s)) required
  • Fellowship training in cardiology or related subspecialty is required, and additional clinical practice is preferred 
  •  >2 years of experience in clinical development in pharma, biotech, and/or CRO
  • Evidence of strong writing and presentation skills is required 
  • Strong working knowledge of global clinical trial regulations and best practices
  • Willingness to travel domestically and internationally (expect 15% travel)Strong team facilitation skills
  • Excellent written and oral communications
  • Comfortable presenting to internal and broad external audiences
  • Effectively anticipates challenges and proactively addresses them
  • Can manage and prioritize multiple activities
  • Works well in a highly matrixed environment as would be expected in a biotech company
  • Can influence peers and external partners very effectively