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Clinical Research Scientist
3 months ago
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
Named Science’s Top Employer in 2021, 2022, and 2023Insmed 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 were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for three years in a row.A Certified Great Place to WorkWe 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 Clinical Research Scientist (CRS) will support and work predominately with the Medical Monitor for assigned protocols and/or projects, partnering with vendors and cross functional teams. The CRS will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as well as overall program support ensuring the adherence to all standard operating procedures (SOPs).
Responsibilities
ResponsibilitiesParticipate in cross functional teams to develop and implement Clinical Study protocols within clinical program(s). Responsibilities include but are not limited to:Collaborate with internal teams, CROs and external vendors to prepare, review and finalize clinical protocol documentsContribute to scientific and operational aspects and stages of the protocol development and execution from study design planning through final reporting of result. Provide scientific input and review of protocol data, support in assessing medical monitoring reports, study integrity/conduct and protocol oversightSupport 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, Investigator Brochures, and briefing books) and aid in the development of responses to regulatory authorities when questions arise for the protocolSupport enrollment projections and assist with the development and implementation of subject recruitment and retention strategiesProvide scientific support to the study teams, including:Collaborate with team members in the review and development of Data Management activities including development of eCRFs, edit checks, report development and database lock processesParticipate in activities related to review of data review, database lock, medical monitoring and query resolution for the protocolWork with medical monitors and drug safety vendor(s) to provide support and scientific review of adverse eventsProvide scientific review of statistical analysis plansSupport corporate objectives:Develop, review and revise departmental and corporate SOPs and processesProvide clinical development and technical expertise in support of due diligence activitiesSupport regulatory activities at the protocol level to develop, prepare and respond to regulatory authorities QualificationsPharm.D., Ph.D. or M.D. with a minimum 3 years of drug development experience, particularly Phases I-II Knowledge of pharmacokinetic applications related to drug disposition Strong medical writing and presentation skillsUnderstanding of biostatistics and data management Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documentsExcellent written and oral communication skillsAbility to work in high paced working environmentDemonstrated team-building skills and the ability to work successfully in a matrix team environment.Analytical, negotiation, meeting management, cross-functional team and leadership skillsExperience with EDC systems, experience with RAVE and J-Review preferred Conflict management, time management and organizations skills requiredTravel requirement approximately 5-10% based on protocol development stage and program needs
Salary Range
Insmed takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $147,000.00 to $206,333.00 per year
Compensation & Benefits
We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:Flexible approach to where and how we work, regionally basedCompetitive compensation package including bonus Stock options and RSU awardsEmployee Stock Purchase Plan (ESPP)Flexible Vacation Policy Generous paid holiday schedule and winter break ADDITIONAL U.S. BENEFITS:401(k) plan with company matchMedical, dental, and vision plansCompany-provided Life and Accidental Death & Dismemberment (AD&D) insuranceCompany-provided short and long-term disability benefitsUnique offerings of pet, legal, and supplemental life insuranceFlexible spending accounts for medical and dependent careAccident and Hospital Indemnity insuranceEmployee Assistance Program (EAP)Mental Health on-line digital resourceWell-being reimbursementPaid leave benefits for new parentsPaid time off to volunteerOn-site, no-cost fitness center at our U.S. headquarters
Additional Information
Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Applications are accepted for 5 calendar days from the date posted or until the position is filled.#LI-JK1#LI-RemoteJob SummaryExternal ID: R1469Job Function: Clinical DevelopmentRemote: YesSalary Range: $147,000.00 to $206,333.00 a yearPosition Location (WD) : Location: US-USA-NJ-Bridgewater
