Associate Director, Clinical Supply
Pulmovant
full-time
Posted on:
Location Type: Remote
Location: Remote • Massachusetts • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Provide planning and execution of Clinical Supply Chain activities to support Pulmovant clinical studies globally.
- Coordinate operations including clinical packaging, labeling, and distribution.
- Actively manage all inventory, logistics and forecasting for the clinical study.
- Be the subject matter expert related to clinical drug supply during all phases of the clinical trial.
- Support activities leading to the implementation of global clinical inventory management, supply planning and distribution systems consistent with meeting cGMP, clinical development programs, corporate objectives.
- Responsible for vendor management including performance metrics and contractual agreements.
- Directly oversee contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials.
- Manage, coach and mentor Clinical Supply Managers.
- Develop best in class clinical supply area.
Requirements
- Minimum of 7 years of related experience in the pharmaceutical industry with at least 5 years of direct experience in Global Clinical Supply Management.
- Prior investigational drug product experience and prior GCP training is required. Recent industry experience with clinical supplies or clinical operations is preferred.
- Ability to communicate and maintain collaborative relationships effectively with key internal and external stakeholders.
- Proven ability to select, secure and manage external vendors to achieve results and control expenditures
- Demonstrated experience with global clinical supply forecasting, planning, packaging, labeling, inventory management, IVRS systems, clinical trial designs (randomized, double, blind, placebo controlled)
- Thorough knowledge and understanding of cGMP, ICH/cGXP guidelines and global Health Authority requirements.
- Proficiency in computer software applicable to IVRS/IWRS, Excel, Power point and MS Project.
- Good organizational, communication and presentation skills, effective project and time management skills and the ability to work under pressure.
- Experience with regulatory submissions a plus.
Benefits
- Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
- It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Global Clinical Supply Managementclinical supply forecastinginventory managementpackaginglabelingIVRS systemsclinical trial designvendor managementcGMPGCP
Soft skills
communicationcollaborative relationshipsproject managementtime managementcoachingmentoringorganizational skillspresentation skillsability to work under pressurestakeholder management