Associate Director, Clinical Science Lead

3 weeks ago

Burlington, Massachusetts, United States Cardurion Pharmaceuticals, Inc Full time
Job Description

Cardurion Pharmaceuticals, Inc. is seeking a highly skilled Associate Director, Clinical Science to join our Clinical Development team. This role will play a critical part in supporting the execution of our mission to bring new therapies to patients with cardiovascular disease.

Key Responsibilities:

  • Act as primary point of contact for medical inquiries from sites, CROs, and site monitors, providing timely and accurate responses.
  • Collaborate with internal Clinical Operations to ensure seamless site selection, start-up activities, and ongoing site management.
  • Support the creation and review of clinical slides for internal and external meetings, ensuring high-quality content and presentation.
  • Assist in the collection and compilation of data, coordinating review and submission to scientific meetings for abstracts, posters, and other publicly distributed materials.
  • Contribute to the authoring of key clinical study documents, including protocols, clinical study reports, investigator brochures, and regulatory authority briefing books.
  • Perform clinical review of data listings and essential study data within generated statistical reports, partnering with Data Management to generate relevant queries.
  • Attend Safety Review Meetings and track or analyze potential safety events within a given study and across studies in conjunction with Safety.
  • Draft study clinical narratives as needed for health authority submissions and final Clinical Study Reports.
  • Review and develop Investigator Meeting agendas with Operations, providing additional support with site training as needed by CRO/site monitors.
  • Actively participate in CRF design and review for CRF design and instructions for unique CRFs, as well as data quality plan and study data review plan.
  • In conjunction with Safety, review SAE narratives generated and provide feedback as needed.
  • Establish and/or coordinate use of consistent ICF risk language based upon IB/IND updates, protocol eligibility criteria, protocol dose modification criteria, protocol safety language, CRFs, and CRF instructions across studies.
  • Build strong relationships with sites and key opinion leaders.

What We Offer:

  • Highly competitive healthcare coverage, including medical, dental, and vision insurance.
  • Fully funded HSA for high-deductible PPO Plan.
  • Flexible Spending Accounts for medical expenses and dependent care expenses.
  • Four weeks of Paid Time Off annually.
  • 401(k) with 50% match on first 4% deferred.
  • A suite of Cardurion paid insurance coverage, including life insurance, short-term and long-term disability.
  • Ten company-paid holidays and Year-End shutdown.

Cardurion Pharmaceuticals, Inc. 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. We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Requirements:

  • Advanced Clinical/Science degree required (e.g., PharmD, PhD, MD).
  • Minimum of five years of pharmaceutical industry experience in clinical development.
  • Cardiovascular experience a plus.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
  • Experience working on cross-functional teams.
  • Outstanding communication skills (verbal and written).
  • Ability to interact and effectively communicate with all levels of personnel within the organization and with clients of the Sponsor company (i.e., investigators, vendors, and CROs).
  • Demonstrated strong organizational and interpersonal skills, building internal and external relationships, influencing, conflict resolution, critical thinking, and problem-solving with a keen attention to detail.
  • Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
  • Experience with basic statistical principles and techniques of data analysis, interpretation, and clinical relevance.
  • Basic programming skills a plus.
  • Understanding of product and safety profiles.
  • Familiar with GCP, ICH, and other relevant guidelines.
  • Strong working knowledge of applications in Microsoft Office suite, including Excel and PowerPoint.
  • Ability to travel as needed (up to 20%).

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