Insmed Incorporated

Senior Director, Clinical Trial Operations

ID
2019-1259
Job Function
Clinical Operations

Company Description

About Insmed!

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.

Overview

The Senior Director of Clinical Operations will manage clinical operations staff to ensure the effective and efficient execution of operational aspects of clinical study planning implementation, data delivery and reporting. This position will also have oversight responsibility for Insmed’s upcoming Phase I programs.   He/she will represent Clinical Operations in a range of cross-functional groups, global functional committee(s) and initiatives intended to enhance function and company efficiency and productivity, regionally, and globally.   

 

This position reports directly to the Vice President of Clinical Operations & Medical Writing.   This is a supervisory position with direct reports. 

 

The ideal candidate must have a minimum of 3 years Phase 1 experience and be already working at a Director/Sr. Director level.

Responsibilities

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

  • Act as the primary Operational Lead over an entire compound. Ensure consistent and successful execution of all operational aspects of regional and global studies as appropriate, including staff resourcing, timelines, budget, data delivery and reporting, vendor management, GCP, etc.
  • Develop operational strategies for implementation of clinical studies regionally/globally in conjunction with project teams and other cross functional departments.
  • Responsible for the oversight and resourcing of all Insmed Phase I or specialty trials.
  • Ensure a “Quality Mindset” is in place across the organization by focusing on detailed plans to monitor the conduct of our studies, the management of our vendors and working closely with our QA organization to implement and manage a process for Inspection Readiness.
  • Member of the Clinical Operational leadership team, enabling cross functional and regional collaboration, delivery of regional and global objectives and implementation of process improvements.
  • Contribute to the development and review of regional/global policies and procedures. Ensure compliance with all Company/Regulatory requirements & TMF quality standards.
  • Work with outsourcing procurement management to optimize the vendor governance structure, incorporate performance metrics, and contribute to outsourcing discussions.
  • Provide leadership to Clinical Operations staff and to project teams for vendor evaluation, selection, management and quality-based oversight.
  • Support the Vice President of Clinical Operations and above in establishing and maintaining an organizational structure and staffing to effectively accomplish the Clinical Operations goals and objectives. May be asked to represent the Clinical Operations Department at senior management meetings on behalf of the Vice President.
  • Responsible for the management and leadership of the Operations staff within the Clinical Operations group including recruitment, training, mentoring, career development, work assignments, performance evaluations and discipline of staff.

Qualifications

About you!

 

Education:

  • Qualified candidates must have a bachelor’s degree from an accredited college or university; A Master’s degree in the Sciences is acceptable.
  • Candidates with a bachelor’s degree in the sciences with substantial experience may be considered for this position.

Knowledge & Experience:

  • 18 years relevant experience is required with at least 3 years at the Director/Sr. Director level.
  • A minimum of 3 years Phase 1 experience required for this role.
  • A minimum of 3 years overseeing Global Trials is required.
  • Experience considered relevant includes 3-5 years clinical or basic research in a Biotech company.  Additional Pharmaceutical company, Academic Research Organization (ARO) or Contract Research Organization (CRO),  CRA experience is preferred. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.  
  • Demonstrates advanced knowledge of design and phases of clinical studies (Rare Disease referred) on a global scale, global regulatory issues, CRO operations, and compliance practices.
  • Effectively oversees, manages, and influences CROs to ensure successful execution of the studies, builds strong relationships to create strong alliances.
  • Effectively negotiates and influences to solve high impact/scope problems and exposure organizational problems.
  • Understands, identifies, mitigates, and communicates risks at the operational level.
  • Effectively leads and influences within the matrix at the senior leader levels within and outside the organization; manages functional or direct reports.
  • Develops and executes strategies to improve processes and set direction in Study Management and related areas such as compliance, CRO management, risk management, etc.

Skills:

  • 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).
  • Must successfully exhibit Insmed’s five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies. 
  • Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Additional Information

Travel Requirements:

  • Up to 20% 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.

 

 

#LI-KD1

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Need help finding the right job?

We can recommend jobs specifically for you! Click here to get started.