Sr. Clinical Scientist

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

 

Consistently Ranked Science’s Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

  

 

 

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

  

 

Overview

The Senior Clinical Research Scientist (CRS) will support and work predominately with the Clinical Trial/Indication Lead(s) and Medical Monitor(s) for assigned protocols and/or projects, partnering with vendors and cross functional teams. The Senior CRS will provide clinical and scientific support to clinical development and operations, regulatory, medical affairs, drug safety, and quality assurance teams, as well as overall program support ensuring the adherence to all standard operating procedures (SOPs)

Responsibilities

Participate in cross functional teams to develop and implement clinical studies within clinical program(s). Responsibilities include but are not limited to:

• Collaborate with internal teams, contract research organizations (CROs), and external vendors to prepare, review and finalize clinical study documents and plans
• Contribute to scientific and operational aspects and stages of the protocol development and study execution, from study design planning through final reporting of results 
• Provide scientific input and review of clinical study data, support in assessing medical monitoring reports, study integrity/conduct, and study oversight
• Support preparation of abstracts, manuscripts, presentations, and materials for meetings as it related to the protocol(s) and program 
• Provide protocol level scientific review of information to support the development and updates for regulatory documents (i.e., IND submissions, IND Annual Updates, DSUR, and Investigator Brochures)
• Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies

Provide scientific support to the study teams, including:

• Collaborate with team members in the review and development of Data Management activities including data cleaning, eCRFs, edit checks, report development, and database lock processes
• Participate in activities related to data review, database lock, medical monitoring, and query resolution
• Work with other clinical scientist(s), medical monitors, and drug safety to provide support and scientific review of safety data
• Provide scientific review of study plans

Support corporate objectives:

• Development, review, and revision of departmental and corporate SOPs and processes
• Support regulatory activities at the protocol level to develop, prepare and respond to regulatory authorities  

Position Requirements (Required and/or Preferred Skills, Experience and Education):

• Advanced degree preferred (DPT, Pharm. D., Ph.D., M.D./ M.D. equivalent) with a minimum 5 years of drug development experience
• Experience with EDC systems (i.e., RAVE) and data analysis tools (i.e., J-Review) required
• Strong medical writing and presentation skills
• Basic understanding of biostatistics and data management 
• Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents
• Excellent