Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live. Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.
About the Role!
The primary responsibility is the day to day management and oversight of clinical trials in
collaboration with a Dynamic Clinical Sub-team.
• Provides management of a clinical study(s) and clinical operations aspects of a drug development program.
• Manages and supervises the operational aspects of Insmed’s clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites.
• Leads CRO and other vendor selection and reviews contracts/work orders
• Provides mentoring to junior team members and/or management and development of direct reports, as required.
• Reviews metrics and Key Performance Indicators to ensure oversight of clinical trial progress.
• Participates in SOP and process development activities for Clinical Operations functions.
• Manages clinical program budgets and execution program timelines.
• Oversees in the day to day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and central labs
• Participates in investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meeting
• Participates in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials.
• Presents trial status and clinical operations strategy to project team and management.
• Reviews and approves specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials.
• Approves action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
• Attends site visits to ensure oversight of CRO.
• Bachelor’s degree in a scientific discipline required. Advanced scientific degree is preferred.
• The candidate should have a minimum of 7 years in trial management with a sponsor company managing various phase clinical trials.
• Experience in clinical trial conduct in multiple phases of development across several therapeutic areas is required.
• Experience in CRO, vendor and laboratory selection and oversight is required.
• Experience in the management across a development program and participation in NDA/sNDA filing is preferred.
• Must have excellent communication skills (verbal and written).
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
We offer a that includes , , , . This position is also bonus eligible.
Insmed is an Equal Opportunity Employer and will evaluate all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local 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.
Please note that we review every submission and we will keep all submissions on file for six months.