Insmed Incorporated

Senior Director, Clinical Trial Operations

ID
2020-1286
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

About the Role!

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

The Director, Clinical Operations is accountable for providing the leadership, strategic, operational planning and oversight of between 1-3 compounds, to ensure all programs are delivered on time, within budget and with high quality. This role will manage clinical operations staff to ensure the effective and efficient execution of all operational aspects of clinical study planning, implementation, data delivery and reporting. 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.

Responsibilities

  • 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.
  • 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 to assist in the 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.
  • 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 ongoing feedback to and of staff.
  • Benchmark, track and report operational and study metrics with the ability to digest complicated or complex issues and communicate program statuses in a concise fashion to an executive audience with the ability to identify critical path items and mitigation plans.
  • Oversight of compound budget with the ability to manage variance to a minimal threshold. Ability to manage the accrual process as well as provide budget forecasting and scenario planning based on multiple study designs.
  • Able to represent Clinical Operations in a professional manner to executive audiences including attendance at requested meetings (i.e Global Clinical Team, Global Project Team, etc.)

Qualifications

About you!

 

Knowledge & Experience: 

  • Demonstrates advanced knowledge of design and phases of Rare Disease clinical studies on a global scale, global regulatory issues, CRO operations, and compliance practices.
  • Effectively oversees, manages, and influences CROs and third-party vendors 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.

Qualifications:

  • Requires a bachelor’s degree in the life sciences, healthcare, or related field with 15 years of progressive experience in a Clinical Operations role.
  • Experience considered relevant includes clinical or basic research in a Pharmaceutical company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred.
  • Knowledgeable in all aspects of clinical operations, project management, the drug development process, and clinical trial conduct, including systems and procedures, as well as the regulations and requirements governing such conduct (including, but not limited to, ICH / GCP and regulatory requirements).
  • Experience managing staff and providing oversight of department activities
  • Ability to prioritize and manage multiple tasks, and to delegate responsibility as necessary.
  • Analytical, negotiation, meeting management, cross-functional team and leadership skills
  • Demonstrated strong team-building skills and the ability to work successfully in a matrixed environment.

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).

Additional Information

We offer a competitive benefits package that includes healthdentalvisionwellness programs, employee discount programs, 401k and more. 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.

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