Senior Clinical Manager

US-NJ-Jersey City
Job ID
2017-1076
# of Openings
1
Category
Medical Affairs

Overview

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma America, Inc. (MTPA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

                                                                                                                                                  

With the recent FDA approval and availability in the U.S. of RADICAVA™ (edaravone), MTPA is rapidly expanding our operation across all functional areas to launch this new product in the U.S. market. Concurrently, the company is expanding its research efforts and exploring collaborations with partners to discover and bring treatments to market for unmet medical needs including orphan diseases. We currently seek motivated professionals who share our vision of scientific excellence, innovation, and unwavering dedication to improving the lives of patients. 

 

The Senior Clinical Manager plays an integral role in supporting the Medical Affairs team. The incumbent is responsible for overseeing clinical trial management related to non-interventional studies, and building effective relationships with external stakeholders and agencies. This role also interacts with internal teams to support Medical Affairs Operations strategy and tactics. The incumbent will provide services to Medical Affairs to include, but not limited to: clinical trial management, project management, vendor management, and document tracking. 

Responsibilities

 

  • Clinical Management: Facilitate the communication between internal project team and external stakeholders for non-interventional clinical studies related to pre-approval special access, independent research and registry study.
  • Project Management: Provide project management assistance in different projects related to Scientific Affairs initiatives. Facilitate communication across internal and external stakeholders for multiple clinical study related programs.
  • Vendor Management: Operationalize vendor selection, budget tracking and project timelines. Facilitate reasearcher and CRO for non-interventional studies and Pre-Approval Special Access program. Collaborate with colleagues within Medical Affairs and cross-functional stakeholders to maximize vendor management efficiencies, share and apply best practices.
  • Internal Communication Hub and Document Tracking: Manage Medical Affairs intranet site maintenance and updates, team calendar and distribution list.
  • Process Improvement: Maintain a “wish list” to flag potential process improvement opportunities and support their execution.
  • Problem Solving: Identify and resolve problems in a timely manner; gather and analyze information skillfully develop alternative solutions. Adapt to changes harnessing an ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives.

Qualifications

Qualifications:

  • BA/BS degree in Science related field; preferably advanced degree such as PharmD, PhD
  • 5-10 years of pharmaceutical industry experience
  • Minimum of 5 years of experience in clinical trial management, preferably non-interventional studies
  • Minimum of 2 years of project management experience
  • Proven ability to effectively manage relationships with cross-functional teams in a matrix organization and with external vendors and groups
  • Skilled at managing multiple cross-border projects to timeline and budget; formal project management training and/or certification (e.g., PMP) is a plus
  • Customer service focus towards internal and external customers
  • Self-starter, hard-working and independent
  • Strong analytical mindset
  • Well-honed organizational skills with excellent attention to detail
  • Maintains optimism and energy in the face of change and adversity; proven ability to collaborate and problem solve
  • Willingness to travel 5-10% domestically and internationally

Our Value Proposition:

 

Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate.  At this time, MTPA offers our employees outstanding opportunities for career success coupled with a supportive level of employee benefits:

 

Medical/Dental | Life Insurance | Supplemental Life Insurance/Dependent Life Insurance | Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee’s Savings Plan (401K Plan) | Competitive Paid Time Off

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