Clinical Research Scientist

$147,000 - $206,333/Yr

Insmed Incorporated - Bridgewater Township, NJ

Full-time - Mid Level

Bridgewater Township, NJ

Professional, Scientific, and Technical Services

About the position

The Clinical Research Scientist (CRS) at Insmed will play a pivotal role in supporting and collaborating with the Medical Monitor for assigned protocols and projects. This position is integral to the clinical development process, providing scientific support to various teams including clinical operations, regulatory affairs, and quality assurance. The CRS will ensure adherence to all standard operating procedures (SOPs) while working closely with cross-functional teams and external vendors. The role requires a proactive approach to developing and implementing clinical study protocols, contributing to the scientific and operational aspects of protocol development, and ensuring the integrity of clinical studies from design through to reporting. In this role, the CRS will participate in cross-functional teams to develop and implement clinical study protocols. Responsibilities include collaborating with internal teams, Contract Research Organizations (CROs), and external vendors to prepare, review, and finalize clinical protocol documents. The CRS will also provide scientific input and review of protocol data, assess medical monitoring reports, and oversee study integrity and conduct. Additionally, the CRS will support the preparation of abstracts, manuscripts, presentations, and materials for meetings related to the protocols and programs. The position also involves providing protocol-level scientific review of information to support the development and updates for regulatory documents, such as IND submissions and Investigator Brochures. The CRS will assist in enrollment projections and the development of subject recruitment and retention strategies, while also collaborating with study teams on data management activities. This includes the development of electronic case report forms (eCRFs), report development, and database lock processes. The CRS will work with medical monitors and drug safety vendors to provide scientific review of adverse events and statistical analysis plans, ensuring that corporate objectives are met and that departmental SOPs are developed and revised as necessary.

Responsibilities

• Participate in cross functional teams to develop and implement Clinical Study protocols within clinical program(s).
• Collaborate with internal teams, CROs and external vendors to prepare, review and finalize clinical protocol documents.
• Contribute to scientific and operational aspects and stages of the protocol development and execution from study design planning through final reporting of results.
• Provide scientific input and review of protocol data, support in assessing medical monitoring reports, study integrity/conduct and protocol oversight.
• Support preparation of abstracts, manuscripts, presentations, and materials for meetings as it relates 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, Investigator Brochures, and briefing books).
• Aid in the development of responses to regulatory authorities when questions arise for the protocol.
• Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies.
• Collaborate with team members in the review and development of Data Management activities including development of eCRFs, edit checks, report development and database lock processes.
• Participate in activities related to review of data review, database lock, medical monitoring and query resolution for the protocol.
• Work with medical monitors and drug safety vendor(s) to provide support and scientific review of adverse events.
• Provide scientific review of statistical analysis plans.
• Develop, review and revise departmental and corporate SOPs and processes.
• Provide clinical development and technical expertise in support of due diligence activities.
• Support regulatory activities at the protocol level to develop, prepare and respond to regulatory authorities.

Requirements

• Pharm.D., Ph.D. or M.D. with a minimum of 3 years of drug development experience, particularly Phases I-II OR Bachelor's degree with a minimum of 7 years of relevant experience.
• Knowledge of pharmacokinetic applications related to drug disposition.
• Strong medical writing and presentation skills.
• Understanding of biostatistics and data management.
• Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents.
• Excellent written and oral communication skills.
• Ability to work in a high-paced working environment.
• Demonstrated team-building skills and the ability to work successfully in a matrix team environment.
• Analytical, negotiation, meeting management, cross-functional team and leadership skills.
• Experience with EDC systems, experience with RAVE and J-Review preferred.
• Conflict management, time management and organizational skills required.

Nice-to-haves

• Experience with EDC systems, particularly RAVE and J-Review.

Benefits

• 401(k) matching
• AD&D insurance
• Dental insurance
• Disability insurance
• Employee assistance program
• Employee stock purchase plan
• Flexible spending account
• Flexible vacation policy
• Generous paid holiday schedule and winter break
• Stock options and RSU awards
• Paid leave benefits for new parents
• Paid time off to volunteer
• On-site, no-cost fitness center at our U.S. headquarters