Clinical Supply Lead
3 weeks ago
Job Title: Clinical Supply Lead
Job Number:
28557
Location:
Cambridge,MA
Job Description
Reporting
to the
Clinical
Supply Leader, the
Clinical
Supply Lead (CSL)
will be responsible for end-to-end supply chain activities of
clinical
programs. The CSL will represent the supply chain function on program teams as well as
clinical
study
teams. Responsibilities include forecasting demand for Investigational Product and non-investigational supplies for a program, managing Finished Goods manufacturing activities as well as the distribution process, in compliance with Health Authority regulations and internal SOPs. The CSL builds and maintains critical collaborations with
Clinical
Operations ,
Clinical
Development, Manufacturing, Discovery, Quality Assurance, Regulatory Affairs, and
Operations .
This role has high visibility and far-reaching impact across multiple departments and external vendors.
In addition, there is significant diversity in the types of
clinical
candidates and the global locations of our
clinical
studies
that contribute positively to the scope of this important role
Responsibilities
Has accountability for Investigational and Non-Investigational Product supply
planning
and
execution , inventory control, and distribution activities including label/pack
execution ,
vendor
oversight , and change
management
to support
clinical
study
objectives and timelines.
Partners with
Clinical
Operations
and Project
Management
to identify demand assumptions and create, review, and update the
clinical
supply and demand
plans
In collaboration with the
Clinical
Supply Leader, reviews
clinical
study
protocols
and understands impact to supply; ensure changes in
study
design, enrollment, and regulatory requirements are considered in the supply
plans .
Oversees
vendor
activities including procurement, labeling performance, on-time delivery, quality, and issue resolution.
Monitors inventory levels at depots and
clinical
sites; is proactive with preventative actions to avoid potential supply issues
Required Skills
Bachelor’s degree required; MBA a plus
10+ years of relevant experience in
clinical
drug supply in the
vaccines , pharma, or biotech industry. Experience in supplying international
clinical
studies
strongly preferred.
A collaborative problem solver
Proven track record in managing a
clinical
supply chain in an outsourced model;
management
of CMOs is of particular importance.
Proven track record of strong collaboration with internal and external stakeholders.
Experience in CMO and
CRO
management , including labeling, packaging, and global distribution
Knowledge of cGMPs and regulatory guidance
Strong analytical and organizational skills
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