Clinical Supply Chain Manager

Location
Brisbane, CA, United States
Posted
Jun 09, 2021
Ref
5316763002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women's health and prostate cancer designed to improve the lives of millions. We are on a mission to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We are looking for passionate and enthusiastic individuals who share our excitement for this mission.

Summary Description

We are currently seeking a dynamic, highly motivated, experienced individual for the position of Clinical Supply Chain Manager reports to the Associate Director of Clinical Supply Chain. The preferred location of the position is in Brisbane, CA but flexibility is possible for the right candidate.

The Manager, Clinical Supply Chain position ensures that all clinical trials, including multiple global Phase 3 studies, have timely and adequate supply for administration to patients. The Clinical Supply Chain group is involved in a clinical trial from the early stages of inception to study closure. This role includes demand forecasting, determination of an appropriate presentation to the clinical site and subject, setting production schedules, inventory management at depots and sites, order management and proof of delivery, return or destruction and global distribution logistics including import and export management.

Essential Duties & Responsibilities
  • Act as a key interface between the CMC and clinical teams.
  • Interpretation of a protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time.
  • Manage clinical labeling including label design, translation and production.
  • Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts and regular inventory update to project teams.
  • Manage international distribution and logistics for clinical programs, including importing and exporting clinical supplies
  • Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution instructions with clinical supply chain vendors.
  • Develop supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
  • Setting up Interactive Response Technology (IRT) Systems with the clinical team, including UAT testing.
  • Monitor regularly drug expiration; initiate inventory release and re-supply with the IRT system, serving as the unblinded inventory manager.
  • Write and execute test scripts for supply chain management in the IRT system.
  • Achieve operational objectives by providing information and recommendations to strategic plans and Budget reviews
  • Support department budget activities.
  • Review departmental SOPs and ensure updates and compliance with industrial standards.
  • Develop strong internal collaboration with stakeholders, such as Clinical Operations, Regulatory Affairs, Quality, Pharmaceutical Sciences and Manufacturing functions, to ensure high customer satisfaction
  • Perform other duties as assigned.

Qualifications and Requirements
  • BS degree with 5+ years industry experience in clinical or commercial supply chain management. Title based on experience.
  • Proven experience with forecasting, demand / supply planning, inventory management, clinical, packaging, labeling and distribution including cold chain, import/export and reverse logistics.
  • Experience with clinical blinding practices.
  • Experience in assisting set-up of IRT Systems for global clinical studies.
  • Experience in sourcing and managing comparator drugs and other co-meds for clinical studies.
  • Experience in CMO and CRO vendor management.
  • Working knowledge of drug development process (Phase I-IV).
  • Working knowledge of cGMPs and familiar with US and EU regulations
  • Strong analytical and problem solving skills.
  • Ability to handle multiple projects simultaneously.
  • Proven project management skills.

Core Competencies
  • Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
  • Exercise good judgment and make decision that is appropriate for the organization
  • Results-driven, take initiative and ownership to accomplish work
  • Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
  • Strive for continuous improvement and embrace innovative ideas in daily work

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity