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:

Consistently Ranked Science’s Top Employer

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’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four 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.

Summary: Responsible for the management and oversight of global phase I-IV clinical trials, with a key focus on Ph2b-3, from start up through CSR including, but not limited to, development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, management of third-party vendors for clinical services, management of project timelines and deliverables. Key global trial management support to the Associate Directors (CST Leads), as assigned. Responsibilities:
Leads and coordinates the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines.
Detailed management and oversight of regional trial activities, as assigned.
Effectively manages third-party suppliers to contracted deliverables within quality, cost, and timeline parameters.
Effectively manages and/or assists with cross-functional clinical study team members to achieve deliverables with high quality, on time, and within budget through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning.
Monitors study metrics to ensure quality and performance standards are met by vendors and assigned program staff.
Develops and manages detailed project and other trial-related plans and documentation and provides regular study status updates to senior management.
Manages vendors' adherence to contractual obligations including proactively recognizing changes in scope and collaborating with senior management to ensure timely completion of contractual documents, including change orders.
Provides coaching/mentoring to assigned program staff (CRAs, and CTAs) by demonstrating leadership competencies
Works collaboratively with Clinical Scientist, Clinical Indication/Development Lead, and clinical study team to ensure ongoing review of patient profiles and data listings.
Proactively identifies potential resource needs to management.
Participates in the development and review of department SOPs and process improvement initiatives.
Requirements:
Bachelor's degree in the life sciences, healthcare, or related field.
Minimum of 7+ years of clinical trial management experience within pharmaceutical / biotechnology industry, managing the logistics of clinical trial execution.
Minimum 2+ years of indirect/influence management of team members, including coaching and mentoring for knowledge sharing and enhanced communication and leadership skills
Experience in rare disease and/or orphan indications is preferred.
Experience managing global, large and/or complex studies and project teams is required. Experience in rare disease and/or orphan indications is preferred.
Demonstrated experience managing global CROs and other specialty vendors is essential.
Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations.
Demonstrated strong leadership skills and the ability to work successfully in matrixed team environment.
Can work independently with minimal oversight and proactively initiates before asked to assist colleagues and/or manager
Possess critical thinking skills for problem-solving, conflict resolution, collaboration, and interpretation
Excellent written and oral communication skills, as well as conflict management, time management and organizational skills.
Must successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies.
Compensation & Benefits:

At Insmed, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

Flexible approach to how we work
Health benefits and time-off plans
Competitive compensation package, including bonus
Equity Awards (Long-Term Incentives)
Employee Stock Purchase Plan (ESPP)

For more information on U.S. benefits click here.

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.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.