Assoc Director, Clinical Operations

Insmed, Inc. Bridgewater , NJ 08807

Posted Yesterday

Company Description

About Insmed:

Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.

Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.

Overview

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. This role oversees vendors and/or contractors.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following:

  • 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,dataandadministrativeissueswithinvestigationalsitesand

  • Attends site visits to ensure oversight of CRO.

Qualifications

About You:

  • 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).

Additional Information

Travel Requirements:

  • Up to 30% travel

Insmed is an Equal Opportunity Employer and will judge 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. Insmed is an Equal Opportunity Employer.

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