Director of Clinical Operations, Gene Therapy

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 2023

Insmed 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 Work®

We 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 primary responsibilities are to manage all aspects of clinical operations including study planning, financial oversight, project deadlines and ensuring compliance with Good Clinical Practices as well as federal and local laws.

Responsibilities

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

• Provide management across multiple studies and clinical operations aspects of gene therapy programs.
• Responsible for the development of, and the oversight for execution of clinical studies milestones to support company budgets, and quality standards.
• Ensure the clinical department follows appropriate guidelines as it relates to Good Clinical Practices as well as federal and local laws processes and procedures.
• Maintain good communication with other departments to foster strong relationships in connection with matters related to clinical projects.
• Manage and participate in developing and drafting protocols, forms, investigator brochures, clinical study reports and other documents as needed.
• Manage and development of systems, practices, and procedures to ensure efficient and effective clinical trial execution including data management and analysis.
• Build and maintain relationships with KOLs and investigators to foster strong partnerships.
• Develop and maintain appropriate metrics to assess performance, compliance and cost effectiveness.
• Leads investigator meetings, kick-off meetings, monitoring training and various CRO (or other vendor) meetings.
• 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.
• Leads Clinical Sub-team meetings.
• Approves action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.

Job Requirements:

• Bachelor's degree required. Advanced degree preferred.
• Minimum of 10 years managing clinical trials at a Sponsor company.
• Experience managing various phases of clinical trials.
• Experience in global clinical trial conduct across several therapeutic areas is desired.
• Experience in rare disease and/or orphan indications is preferred.
• Experience managing the finances of clinical trials, including budgeting, forecast, accruals and invoicing.
• Experience in vendor and laboratory selection, set-up, and management is required.
• Participation in NDA/sNDA filing is preferred.
• Must have excellent communication skills (verbal and written).
• Possess critical thinking skills for problem solving, conflict resolution, collaboration, interpretation and leadership tasks.
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
• Must successfully exhibit Insmed's five (5) core corporate values of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies.
• Domestic and/or international travel required up to 30%

Travel Requirements

Up to 20% travel

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 $179,000.00 to $250,800.00 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 based
• Competitive compensation package including bonus 
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)
• Flexible Vacation Policy
• Generous paid holiday schedule and winter break 

ADDITIONAL U.S. BENEFITS:

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• Well-being reimbursement
• Paid leave benefits for new parents
• Paid time off to volunteer
• On-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.

 

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