Description

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we're in. Are you?

About the Role:
Accountable for providing the leadership, strategic, operational planning and oversight of 1-2 indications within one compound to ensure all are delivered on time, within budget and with high quality. This role may manage clinical operations team members, as delegated by supervisor, to ensure the effective and efficient execution of all operational aspects of clinical study planning, implementation, data delivery and reporting. Represents 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 role can be hybrid or remote.

What You'll Do:

• Primary operational lead over an 1-2 indications within one compound, in collaboration with the Senior Director, Clinical Operations. Ensures consistent and successful execution of operational aspects of regional and global studies as appropriate, including timelines, budget, data delivery and reporting, vendor management, GCP, etc.
• Develops 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.
• Contributes 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.)

Who You Are:

• Bachelor's degree in the life sciences, healthcare, or related field. Advanced degree preferred.
• Minimum of 12+ years of progressive experience in a Clinical Operations role, and minimum of 7 yrs managing direct reports. Experience considered relevant includes clinical or basic research in a Pharmaceutical company, Academic Research Organization (ARO) or Contract Research Organization (CRO).
• Experience in rare disease and/or orphan indications 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
• 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 help resolve 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 and/or direct reports.
• Develops and executes strategies to improve processes and set direction in related areas such as compliance, CRO management, risk management, etc.
• Ability to prioritize and manage multiple tasks, and to delegate responsibility as necessary.
• Actively demonstrates analytical, negotiation, meeting management, cross-functional team and leadership skillDemonstrated strong team-building skills and the ability to work successfully in a matrixed environment.
• Must have excellent communication skills (verbal and written).
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
• Must successfully exhibit Insmed's five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies.
• Up to 25%, domestic and international travel required

Pay Range:
$179,000.00-250,800.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. 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.