Clinical Supply Lead - Cambridge, United States - The University of Texas MD Anderson Cancer Center

Description

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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