Clinical Research Scientist

Company Description

Entrepreneurial
Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), 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.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.

Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide
leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion.
The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO’s and other vendors.  He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible.

Job Description

• Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory
  submissions such as INDs.

• Author abstracts and manuscripts for publication in peer-reviewed journals.

• Evaluate and select potential investigative sites in collaboration with Clinical Operations staff.

• Ability to prepare, present and defend complex aspects of protocol design and/or study data at
  investigator and internal meetings.

• Oversee and coordinate the collection of and/or collect pre-study documents

• Participate in data review and discrepancy resolution, team meetings/presentations with increasing
  levels of independence and support the Program Clinical Leader or Sr. Management as needed.

• Assist in managing regulatory safety reporting with the following: SAE queries and follow-up,
  annual reports, investigator brochures, ability to learn various databases.

• Critically review and synthesize complex information from reviews of the scientific and clinical
  literature.

Qualifications

• Minimum 2-5 years of pharmaceutical industry clinical trial experience.

• Experience in immunology or endocrinology therapeutic areas is a plus.

• Primary experience with development of clinical trial protocols.

• Medical or scientific writing experience a must and familiarity with clinically applied science or
  pharmaceutical development.

• Good understanding of FDA regulatory, ICH, and GCP requirements.

• Excellent communication skills, written and verbal.

• Superior interpersonal communication and the ability to work across company disciplines and functional units.

• Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines.
  

• Attention to detail and a commitment to high quality and on-time deliverables are key success factors.

• Willingness to travel up to 30% domestically and internationally.

Additional Information

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, Mitsubishi Tanabe Pharma America offers our employees unparalleled 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