Insmed Incorporated Hiring for Director, Clinical Operations, Gene Therapy job in San Diego Full Time

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 and 2022

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 two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.

Overview

This Role is responsible for the overall leadership, management, and oversight of phase I-IV clinical trials from protocol concept through clinical study report (CSR) to ensure all studies are delivered on time, within budget and with high-quality data. Leads the cross-functional Clinical Study Team (CST), CRAs, CTAs, to ensure execution of all operational aspects of clinical study(s) planning, implementation, data delivery, and reporting.

• This is a supervisory position
• The Role may have mentoring and coaching responsibilities of more junior colleagues
• This Role oversees vendors and/or contractors

Responsibilities

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

• Provide leadership and management of clinical operations team
• Provide leadership and management of a clinical study(s) and clinical operations aspects of one or more drug development program(s) in compliance with GCP and relevant regulatory guidelines.
• Manage and oversee the operational aspects of Insmed’s clinical trials, including vendors such as central labs, biomarker and specialty laboratories, clinical trial sites, etc.
• Lead Site and vendor selection and review contracts/work orders.
• Provide mentorship to assigned study staff (CTMs, CTAs) or colleagues
• Review metrics and Key Performance Indicators to ensure oversight of clinical trial progress.
• Manage clinical study(s)/program budgets and execution against study(s)/program timelines.
• Oversee the day-to-day clinical trial execution with a focus on site start up, patient enrollment, monitoring, compliance and data flow metrics from the clinical sites and vendors.
• Responsible for the creation and execution of site and team training plans.
• Plan and/or participate in investigator meetings, kick-off meetings, monitoring training, and various vendor meetings.
• Participate in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials.
• Present trial status and clinical operations strategy to project team and management.
• Create and/or review and approve study documents, e.g., informed consent forms, study guidelines, operations manuals, training materials, pharmacy manual.
• Approve action plans to address protocol compliance, safety, data, and administrative issues with investigational
• Arrange and attend site visits.
• Participate in SOP and process development activities across Insmed functions.
• Proactively suggest ways to improve efficiency, optimize processes and/or elevate organizational performance. Lead process improvement initiative(s).

Qualifications

• Bachelor’s degree required. Advanced degree preferred.
• Minimum of 7 years managing clinical trials at a Sponsor company, or Clinical Site.
• Experience managing people / teams
• 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 in 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.

Travel Requirements

Up to 40% travel, domestic and international required.

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 $175,000.00 to $241,667.00

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
• Competitive compensation package including bonus.
• Stock options and RSU awards
• Employee stock purchase plan
• 401(k) plan with company match
• Professional Judgment Vacation Policy
• 11 paid holidays per year and Winter Break (typically between Christmas and New Year’s Day).

ADDITIONAL U.S. BENEFITS:

• Medical, dental, and vision plans
• Company-provided short- and long-term disability plans
• Company-provided life insurance
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity plans
• Supplemental AD&D
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• On-site, no-cost fitness center at our U.S. headquarters
• Paid time off to volunteer

*LI-KM

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.

Please note that we review every submission, and we will keep all submissions on file for six months.