Title: Director/Senior Director, Clinical Development (Cardiology)

Job Code:   CL-07090-W

 

Job Profile

The Director/Senior Director will apply a strong knowledge in Internal Medicine (Cardiology and Rheumatology preferred) and applied research to lead Clinical Development projects focused on the development and implementation of novel molecular diagnostic tests for immune-mediated conditions; direct study design and execution, and data interpretation and analysis; and provide clinical guidance to translational research projects that emphasize high clinical utility, improved patient quality-of-life, commercial viability, and scientific innovation. The candidate will also play a leadership role in the further evolution of clinical applications of the AlloMap® molecular expression test for the diagnosis of heart transplant rejection.

 

Responsibilities

• Design and execute clinical research studies supporting the development of new molecular diagnostic tests
  
• Provide clinical leadership for XDx programs in heart transplant and/or auto-immune disorders
  
• Design and implement AlloMap test clinical outcomes studies
  
• Engage academic leaders and develop collaborative investigative relationships
  
• Guide study data analysis and preparation for presentation and publication
  
• Provide clinical support for AlloMap test physician education and molecular testing inquiries
  
• Participate in training of medical science liaisons and transplant account managers
  
• Design and lead clinical advisory board meetings
  
• Represent Clinical Development on project teams and at management review meetings
  

 

Qualifications

• M.D. degree, BC/BE in Internal Medicine; Cardiology or Rheumatology preferred and at least 2 years of relevant industry or equivalent experience
  
• Experience with gene expression profiling or other clinically applied genomics platforms preferred
  
• Strong applied clinical research background with experience in clinical trial design/execution under GCP SOPs and working with interdisciplinary study teams
  
• Experience in clinical development of (molecular) diagnostic tests preferred
  
• Experience in developing and implementing clinical plans, and individual studies to enable product development
  
• Outstanding interpersonal skills and collaborative work style
  
• Excellent quantitative analytical background
  
• Strong written and oral communication skills; experience with writing and reviewing study protocol and report documents
  
• Motivation, enthusiasm and creativity necessary for innovative problem-solving
  
• Willingness to travel to clinical research sites in the United States and Europe
  

 

Interested in applying for this job?

Please email your statement of interest and resume to jobs@xdx.com.
If possible, submit resume as a Word document. Principals only please.

 

Only local candidates will be considered

 

XDx is an Equal Opportunity Employer

Title: Clinical Research Associate

Job Code: CL-07097-W

 

Job Profile

As the “face of the company” to our clinical partners, the Clinical Research Associate will work as a member of the XDx Clinical Development team on clinical studies designed and executed in collaboration with university medical centers to study gene expression in organ transplant patients to develop new molecular diagnostic tools.  The CRA will oversee all aspects of clinical data management, with an emphasis on rigorous maintenance of the integrity, privacy and completeness of patient information provided by individual centers.  Close contact with study coordinators and principal investigators, including travel to university sites, is necessary for timely data collection and both the identification and resolution of problems.  

 

 

Responsibilities

• Establish and manage collaborative research studies with academic investigators
• Contribute in the design and maintenance of web-based clinical data entry systems
• Oversee clinical data management with study coordinators and investigators at university centers
• Complete essential research study documentation and perform regular center progress reviews
• Facilitate and ensure clinical data collection and entry
• Conduct review of clinical data at centers and provide final data for experimental analyses
• Work on complex problems and perform analysis of situations with in-depth evaluation of factors
• Travel to research centers to educate and train study coordinators on study procedures

 

Qualifications

• Bachelors degree in a scientific discipline
• Must have a minimum of 2-4 years clinical study management experience in industry setting
• Strong experience with clinical studies and data analysis is highly desirable
• Experience with clinical data management processes from study initiation through completion
• Prior medical background and familiarity with medical diagnostics and diseases highly desirable
• Experience in multi-center clinical studies with university centers strongly preferred
• Interpersonal skills for professional customer interactions with investigators and study coordinators
• Outstanding written and oral communication skills
• Strong working knowledge of GCP related requirements and regulations
• Highly motivated, enthusiastic and ready to manage assigned responsibilities and tasks
• Willingness to travel to clinical research sites

 

Interested in applying for this job?

Please email your statement of interest and resume to jobs@xdx.com.
If possible, submit resume as a Word document. Principals only please.

 

Only local candidates will be considered

 

XDx is an Equal Opportunity Employer

Title: Director, Marketing

Job Code: CO-07110-W

 

Job Profile

XDx is seeking a Director of Marketing who will be responsible for defining brand and product strategies, along with their development and implementation.  The director will also be accountable for commercial and pipeline marketing, interacting with internal departments, field personnel, and external customers and patients.

 

 

Responsibilities

• Define Brand and Product Strategies

• Interpret and Understand Market and Competition
• Gather, Identify, Prioritize Functional and Product Requirements
• Develop Product Roadmap, Collaboratively with Multiple Departments
• Prepare and Review Marketing Collateral
• Foster Relationships with KOL’s, Clinicians, and Other Key Customers and Stakeholders
• Create Demand and Sales Forecasts, Partnering with Sales and Finance
• Provide Field Sales Education Materials and Training, Including Product Positioning
• Develop and Evaluate Pricing and Health Economic Models
• Leverage and Respond to Managed Care Implications
• Manage and/or Collaborate with Ad Agencies and PR Firms
• Plan and Execute Events/Trade Shows
• Develop Promotional and Marketing Plans
• Conduct Market Research – Primary, Secondary, Targeting, Segmentation, Analytics
• Support Field Sales Organization with a Significant Level of Teamwork and Customer Commitment

 

Qualifications

• MBA  Undergraduate degree in basic science, molecular biology, or medical technology preferred
• At least 10 years progressive business experience; marketing/product management experience in IVD, IVDMIA, pharmaceutical, biotechnology, diagnostics, or other related medical field; knowledge of cardiology, pulmonology, or immunology preferred
• Knowledge of transplant markets a plus 
• In-depth understanding of sales and marketing to clinicians.  DTC experience a plus
•  Experience working in Marketing under FDA design control, CLIA, or other regulatory body required 
• Experience launching new products; Full product lifecycle management experience preferred
• Experience managing teams and direct reports
• Excellent written and oral communication skills
• Strong organizational and time management skills
• Ability to manage multiple priorities in a fast paced environment
• Demonstrated ability to lead and participate effectively in cross-functional teams
• Strong interpersonal and leadership skills
• Some travel required

 

Interested in applying for this job?

Please email your statement of interest and resume to jobs@xdx.com.
If possible, submit resume as a Word document. Principals only please.

 

XDx is an Equal Opportunity Employer

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