Clinical Supply Lead

3 weeks ago


Cambridge, United States The University of Texas MD Anderson Cancer Center Full time

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

#J-18808-Ljbffr



  • Cambridge, United States QurAlis Full time

    ABOUT THE COMPANY QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets.  QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with...


  • Cambridge, United States QurAlis Full time

    ABOUT THE COMPANY QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets.  QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with...


  • Cambridge, United States QurAlis Full time

    ABOUT THE COMPANY QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets. QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with...


  • Cambridge, United States QurAlis Full time

    ABOUT THE COMPANY QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets.  QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with...


  • Cambridge, United States Clinical Dynamix, Inc. Full time

    Role: Associate Director, Clinical Operations We are looking for a energetic and passionate Associate Director, Clinical Operations who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharma company and has begun working...


  • Cambridge, United States Agios Pharmaceuticals Full time

    Senior Manager, Clinical Supply Chain  Who we are: is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with...


  • Cambridge, United States ZDA, LLC Supply Chain Recruiting Full time

    Growing R&D Research Company seeking talented Supply Chain Manager - Procurement, that will lead a team of supplier management professionals and serve as the ERP Implementation advisor for the supply chain organization. Will report to the Director of Procurement. Will be responsible to develop, implement and execute supply chain strategies to achieve...


  • Cambridge, United States Cullinan Therapeutics Full time

    Summary: Cullinan Oncology is seeking an experienced Sr. Manager reporting to the Senior Director of Supply Chain, you will support the planning, creation, implementation, build, and optimization of the clinical supply chain to ensure uninterrupted and timely clinical drug supply for Cullinan's clinical programs. Position Responsibilities: Support the...


  • Cambridge, United States TalentBurst, Inc. Full time

    Experienced clinical scientist (PharmD, PhD, Nurse, etc..) in clinical development needed to support rare disease clinical trials from protocol development, study start up activities including investigator meetings, working closely with CRO and internal study team to meet study milestones, regulatory form creation and submission, ongoing data review,...


  • Cambridge, United States TalentBurst, Inc. Full time

    Clinical Engagement Lead Cambridge, MA 1 year contract Job Description : The site Engagement Leader builds partnerships and commitment by active elicitation of information on site specific processes and feedback on trial design. During the trial, sustained engagement encourages bidirectional communication and facilitates learning networks for enhanced...


  • Cambridge, United States Job Juncture Full time

    Job Description Job description: We are hiring a Supply Chain Manager to lead a team of Supplier Management and Small Business professionals and serve as the Supply Chain ERP implementation advisor for the department.Reporting to the Director of Procurement & Property, the Supply Chain Manager will support the supply chain needs of the program offices.This...


  • Cambridge, United States JP Recruiting Agency Full time

    Job Title: Supply Chain ManagerLocation: Cambridge, MAJob Type: Full-timeJob Description:We are hiring a Supply Chain Manager to lead our Supplier Management and Small Business team and serve as the Supply Chain ERP implementation advisor. Reporting to the Director of Procurement & Property, this senior-level role supports the supply chain needs across five...


  • Cambridge, United States Sarepta Therapeutics Inc. Full time

    The Real World Evidence (RWE) lead provides clinical leadership for evidence generation activities, supporting the integration of RWE into Sarepta key strategic initiatives. The role functions in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality...

  • Procurement Manager

    2 hours ago


    Cambridge, United States ZDA, LLC Supply Chain Recruiting Full time

    Growing R&D Research Company seeking talented Procurement Manager, that will lead a team of supplier management professionals and serve as the ERP Implementation advisor for the supply chain organization. Will report to the Director of Procurement. Will be responsible to develop, implement and execute supply chain strategies to achieve quality, cost and...


  • Cambridge, United States Leap Therapeutics Full time

    **Head, Clinical Pharmacology**: **Company Summary**: **General Responsibilities**: ***The Head of Clinical Pharmacology will be responsible for developing and executing the clinical and non-clinical pharmacology strategies for compounds from the pre-clinical stage through first-in-human and into late-stage clinical development. They will support programs by...

  • Associate Director

    4 weeks ago


    Cambridge, United States Cullinan Oncology, Inc Full time

    Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications.A successful incumbent would help integrate...


  • Cambridge, United States The Steely Group Full time

    Reporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/ information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effective implementation and maintenance of the clinical operational study documentation, in accordance with study...


  • Cambridge, United States Relay Therapeutics, Inc. Full time

    The Opportunity: As Clinical Project Associate, you will be accountable for providing clinical trial coordination support, along with implementing operational plans in accordance with regulatory guidelines and ICH/GCP standards. You will be an integrated member of the Relay Tx Clinical Development Operations team making key contributions to the execution of...


  • Cambridge, United States Relay Therapeutics Full time

    The Opportunity: As Clinical Project Manager, you will be accountable for managing clinical studies that will lead the biopharma industry in speed and quality of clinical study design and execution. You will be an integrated member of the Relay Tx scientific team, responsible for the execution of clinical studies that will translate Relay's innovative...


  • Cambridge, United States BlueRock Therapeutics Full time

    The Associate Director, Clinical Sciences, Ophthalmology will be charged with providing medical and scientific support for BlueRock's Ophthalmology programs. Reporting to the Senior Director, Clinical Development, Ophthalmology, this role will work closely with clinical and program leads as well as other subject matter experts to expand and execute on the...