About USDM
USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you will have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown into a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
USDM Life Sciences is seeking a Director of Clinical Supply Chain Management to support our client in overseeing the supply operations for their innovative clinical programs. The candidate will spearhead the setup and oversight of clinical supply chains for studies/programs spanning multiple phases.
Primary Responsibilities
- Manage Interactive Response Technology (IRT) and drug distribution vendors for clinical trials including packaging, labeling, distribution, return, reconciliation, and destruction activities.
- develop the Pharmacy Manual for clinical trial materials (Investigational Medicinal Product, IMP), and ensure IMP is available at sites for dosing of patients during the study.
- Serve as the primary point of contact between various departments and external partners involved in ongoing and new clinical studies, including Tech Ops, QA, Regulatory, Clinical Operations, CROs, and CMOs.
- Oversee clinical supply activities, CMOs, and inventory management.
- Manage the Clinical Supply program for investigation of drug product inventory management and distribution in partnership with CMOs.
- Evaluate drug utilization versus forecast considering country requirements and logistical timelines.
- Initiate, oversee, and resolve departmental deviations.
- Collaborate with cross-functional teams (Clinical Operations, QA, CMC, and Regulatory) to ensure optimal execution of Clinical Supply strategy and identify and address potential risks to the progression of clinical programs proactively.
- Function as the internal point person for addressing product issues, temperature excursions, and deviations originating from clinical sites or depots. Collaborate with Quality Assurance to address any quality-related matters.
Additional Responsibilities
- Facilitate timely startup of new studies through prompt supply availability.
- Manage the creation, periodic review, and maintenance of all Clinical Supply SOPs.
- Serve as a subject matter expert and devise continuous improvement plans for clinical supply GMP, GDP, and business processes.
- Assist in ongoing drug accountability and reconcile end-of-study drug inventory.
- Provide clinical supply and risk mitigation recommendations.
- Oversee inventory management of study drugs and comparators at depots.
- Mentor CSC team members as needed on programs and systems.
Qualifications
- Must be able to work in a collaborative, fast-paced, and cross-disciplinary biotech environment.
- Must be a proactive, adaptable individual who excels in dynamic environments and can work autonomously.
- Extensive experience with clinical trials, particularly in managing Investigational Medicinal Products (IMPs), drug distribution, and inventory management.
- Experience in managing Interactive Response Technology (IRT).
- Strong project management skills.
- Excellent communication and interpersonal skills.
- Strategic thinking and problem-solving skills.
- Thorough understanding of regulatory requirements.
- Ability to mentor and develop teams
Education & Certification
- A Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Supply Chain Management, or a related field.
Working Conditions
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
- Sit or stand at a desk in an environmentally controlled office environment for prolonged periods of time.
- Constantly operate a computer and other office productivity machinery, such as a calculator, scanner, or printer.
- Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Equal Opportunity Statement
USDM Life Sciences is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Compensation
W2 candidates only.
Salary/Hourly Rate Range (W2): USD 90.00 - 96.00
The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.
Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.
Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.
All employees are eligible for USDM's rewards and recognition program.
For more details about our benefits, visit us here: https://usdm.com/careers
