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Associate Director, Clinical Project

2 months ago

Bridgewater, United States Insmed Incorporated Full time
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 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:
The Associate Director, Clinical Project & Planning Management is a member of the Clinical Business Operations team within Development Operations and provides oversight and leadership across clinical programs/trials in areas of project management and planning, including related systems/tools, timelines, study metrics, dashboards/analytics, and Key Performance Indicators (KPIs). This role works closely with the Clinical Program Operations Leads, Clinical Trial Managers/Leads (US & Europe), Clinical Business Operations, and Clinical Program Optimization members within Development Operations as well as cross–functional partners including Program Management, Procurement, and IT to ensure alignment and standardization for trial timelines and reporting. This role also serves as a leader/collaborative change agent in process improvement to enable Insmed to proactively identify and implement industry best practices for study teams to effectively manage trials.

Responsibilities:
Representative responsibilities include, but are not limited to, the following: Planning Management Responsibilities: Supports the Development Operations team with scenario planning, predictive analytics, and critical path analyses, including study timelines, planning support for upcoming trials, and centralization/alignment around global dashboards.

Contributes to the RFP process with support from Procurement, including Bid Grid development.

Leads the ballpark costing initiative including any system implementation.

Partners and interfaces with Global Program Management to establish standard timelines for trials and enhance alignment between the two departments.

Manages the Development Operations Book of Business to ensure updates are captured and new version distributed on at least a quarterly basis.

Project Management Responsibilities: Manages related vendor partnerships and ensures adherence to contractual obligations.

Facilitates regular project reviews to assess trial progress and tracking against timelines and milestone targets, including ownership of Insmed's internal enrollment forecasting tool.

Coordinates monthly Clinical Project Review meetings including scheduling, facilitation, finalization of materials, and distribution to executive leadership.

Manages vendor(s) for clinical trial data visualization dashboards to ensure accuracy of content and data, and manages system enhancements/updates including specifications, user acceptance testing, training, etc. Responsible for driving effective resolution of any issues and ensures appropriate team members are informed and consulted as needed.

Implementation and ownership of new reporting/dashboard system with support from IT and Clinical Systems Lead. Maintains ownership after implementation.

Attends relevant external courses and/or conferences to identify best practices from a Project Management and Planning perspective and applies learnings to Insmed.

Lead and participate in process improvement initiatives by proactively identifying pain points and providing business cases on needed solutions.

Qualifications:Bachelor's degree from an accredited college or university required. Advanced degree is preferred.

The candidate should have a minimum of 8 years' experience in clinical trials with a sponsor or CRO company across several therapeutic areas.

Must have a minimum of 3 years' experience in the RFP process, including bid grid development.

Must have experience managing a reporting/dashboard system.

Extensive experience in clinical contracts administration, and clinical timeline management.

Must have excellent communication skills (verbal and written) as well as conflict management, time management and organizational skills.

Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.

Highly proficient in Microsoft Office (Word, Excel, Project, PowerPoint, Outlook) and SmartSheet.

Must successfully exhibit Insmed's five (5) core values of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies.

Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Travel Requirements:
This role is remote–based. Less than 5% 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 $(phone number removed) to $(phone number removed) 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 vacation 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.