Director, Clinical Science

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 searching for a dynamic Director, Clinical Science to join our growing Clinical Development team. We are looking for someone who is driven to help execute our mission of bringing new therapies to patients with cardiovascular disease. The Director, Clinical Science will support Clinical Science deliverables for clinical trials and programs associated with the clinical development of molecules in early to late stages of clinical development. The optimal candidate will have the desire to proactively participate within a cross functional team of colleagues across several disciplines (clinical operations, pharmacology, toxicology, regulatory, etc.) and can interact with external experts and investigators.

Here’s What You’ll Do

• Act as primary point of contact for medical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate; Assist Medical Director and/or interface internally and externally as the primary clinical science lead of a given study or program
• Act as primary liaison for internal Clinical Operations for site selection, site start-up activities, etc.
• In conjunction with Medical Director, support the creation of and/or review of clinical slides for internal and external meetings (i.e. Investigator Meetings, SIVs, Advisory Boards, Steering Committee Meetings, etc.)
• Assist in the collection and compilation of data and coordinate review/submission to scientific meetings for abstracts/posters and other publicly distributed materials
• Assist in authoring key clinical study documents, including Protocols, Clinical Study Reports, Investigator Brochures, Regulatory Authority briefing books, etc. Conduct literature searches, draft background sections, and ensure that standardized disease/molecule specific language in incorporated (i.e. eligibility and dose modification criteria)
• 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.
• Attend Safety Review Meetings and track or analyze any potential safety event within a given study and across studies in conjunction with Safety
• Draft the study clinical narratives as needed for health authority submissions and for final Clinical Study Report
• Review and develop Investigator Meeting agendas with Operations. Provide additional support with site training as needed by CRO/site monitors (i.e. study coordinator and monitor meetings)
• 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 as required, protocol eligibility criteria, protocol dose modification criteria, protocol safety language, CRFs, and CRF instructions across studies
• Build strong relationships with sites and KOLs
  
  

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:

• Advanced Clinical/Science degree required (e.g. PharmD, PhD, MD)
• Minimum of 7 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%)