Assoc Director, Clinical Supply & Logistics
Insmed Incorporated

Job Info

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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 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 2022, we became Great Place to Work-certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in Biopharma TM List, Small and Medium, and one of the Best Workplaces in New York TM , which recognizes companies headquartered in NY, NJ, and CT.

Overview

The Associate Director, Clinical Supply Chain will be responsible for the development, management and execution of demand and supply plans for clinical programs, ranging from nomination through Phase IV. In this role, the incumbent will collaborate with Clinical Development, Clinical Operations, Regulatory, Quality, Finance and external CDMOs/CMOs to deliver clinical supplies globally. As a part of the Clinical Supply Chain organization, the Associate Director will be expected to bring a strategic mindset in addition to operational expertise, financial planning, strong leadership, and excellent collaboration and communication skills.

Responsibilities

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

• End-to-End coordination and execution of all clinical supply related activities including label development, demand planning, supply planning, and logistics for clinical programs.
• Knowledge of clinical production processes and design strategies for patient kits to best support the clinical trial study designs.
• Support the IRT user specifications, medication management oversite and UATs.
• Execute upon clinical supply chain sourcing strategies utilizing 3rd party providers in coordination with CSC Forecasting & Planning, Clinical Development Operations for current and future programs.
• Coordinate with Supplier Relationship Management for clinical suppliers to which includes maintaining key performance metrics and budget/invoice tracking.
• Support Global Clinical Supply Chain in all current and future Global Product Teams for clinical supply strategy and execution.
• Establish SOPs, WPs and procedures for clinical trial material packaging, labeling, and distribution to ensure compliance with cGxP requirements.
• Support the development and implementation of study specific pharmacy manuals.
• Work closely with supply chain colleagues to ensure consistency across processes and tools and implementation improvements to show sustainable results.
• Manage the operational execution of clinical supply strategies for specific clinical programs.
• Understanding of the roles and responsibility of all functions represented on cross functional drug development teams.
• Ability to build, test and coordinate the development of clinical forecasting & demand planning systems.
• Proactively address risk management issues and implement business and study continuity strategies.

Qualifications

• Bachelor's Degree in science or business-related field; Masters/MBA in Operations preferred.
• Minimum 7 years of experience in pharmaceutical company or related industry
o Minimum of 5 years in drug development, clinical supply chain management and/or clinical manufacturing operations.
• Ability to rapidly navigate the organization and identify, align, and integrate cross-functional resources into cohesive teams.
• Strong teamwork and collaboration skills.
• Experience in multi-functional areas (Clinical, Regulatory, Quality) demonstrating a broad understanding of pharmaceutical development.
• Expert knowledge of all phases of drug development, of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment
• Ability to manage Contract Manufacturing Organizations and Clinical Supply Providers
• Strong background in cGMP, cGDP, cGLP and ICH requirements
• Strong ability to handle multiple projects simultaneously.
• Proficiency in computer software applicable to IRT, Excel, PowerPoint and MS Project and Demand & Supply related systems.
• Extensive in planning and execution of investigational materials supply strategies

Travel Requirements

Up to 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 $135,000.00 to $188,333.00

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

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.

This job has expired.