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Manager, Clinical Trial Supply

Employer
Alkahest, Inc.
Location
San Carlos, CA
Start date
Sep 6, 2019

View more

Discipline
Clinical, Clinical Project Management, Clinical Trials
Required Education
Bachelors Degree
Position Type
Full time

Job Details

Uniquely positioned to enhance quality of life in aging, at Alkahest, we are pioneering science that is rapidly being translated to the clinic. Our approaches utilize in vivo, in vitro, proteomic, and molecular techniques to identify new therapeutics and apply them to patients. 

We are seeking a Manager, Clinical Trial Supply with experience in the pharmaceutical or biotech industry. You will manage clinical supply chain oversight and logistics for both small molecule and biologics programs. The ideal candidate will have a background specific to pharmaceutical or biotechnology products, and the unique clinical supply chain challenges present in a GMP environment.

PRIMARY RESPONSIBILITIES

  • Lead clinical supply function and manage overall project timelines to align clinical trial requirements with drug product availability, secondary packaging, labelling and supply distribution
  • Support clinical study teams with study drug demand, forecasting, and logistics planning
  • Lead and direct partnership with drug suppliers - manage relationships as well as forecasting and demand planning 
  • Create the replenishment forecast for the contract manufacturer, review and/or aggregating demand to ensure all supply streams are represented
  • Track all supply inventories, allocate product lot, procure supply when necessary 
  • Manage and negotiate contract manufacturer proposal/contract, obtain purchase orders with necessary approvals, perform monthly accrual with finance team and process invoices 
  • Work with Quality Assurance for batch record review to ensure release of product domestically and internationally
  • Review and resolve all shipment issues (damage, temperature excursions, non-compliance).  Analyze root cause and design solutions to resolve recurring problems, including deviation and CAPA ownership
  • Provide expertise with packaging design/technologies
  • Creatively seek out ways to improve the supply chain process
  • Other duties may be assigned.

KNOWLEDGE AND EXPERIENCE

  • A Bachelor’s degree in business or biological sciences required, Supply Chain Management or related discipline preferred
  • Minimum of 5 years of planning experience in a combination of clinical supply chains in biotech/pharmaceutical industry
  • Working knowledge of cGMPs and pharma industry procedures and regulations
  • Theoretical and practical knowledge of clinical supply forecasting, demand planning and manufacturing capacity management
  • Knowledge/proficiency as a project manager, master production scheduler/planner
  • Ability to anticipate/define problems, collect and analyze data, draw valid conclusions and execute corrective actions and preventative measures
  • Global release and distribution logistics and cold chain experience is required
  • Must possess import/export expertise including customs, transportation, and regulatory guidelines
  • Strong interpersonal skills and the ability to work independently, as well as a member of a team
  • Must have exceptional verbal, written, presentation, communication and negotiation skills
  • Proficiency with: Microsoft Word/Excel/PowerPoint/Project software

Company

At Alkahest, we strive to lead the way towards effective therapies for patients suffering from diseases associated with the detrimental processes of aging. We believe that as an industry, we simply haven’t done enough to help drive solutions for the most under-treated and devastating diseases affecting this growing demographic. We want to help.

Aging is the dominant risk factor in degenerative diseases. Many of the pressing age-related and neurodegenerative diseases have a profound impact on patients and their caregivers, yet have very limited treatment options. Alkahest has embarked upon a simple but elegant approach to treat disorders of aging by capitalizing on the body’s own natural regulatory and communication mechanisms, leveraging the plasma proteome. The promise of this science, and the potential to make a difference to patients around the world, was the founding principle of Alkahest.

For all of the great progress we have made so far, we credit our dedicated and impassioned team for driving our successes. Our culture is warm and supportive, genuine and ethical, rigorous and scientific, and collaborative yet entrepreneurial. Based in Silicon Valley, home to many leaders in the biotechnology industry, the heart of our culture is scientific innovation. We work hard, yet we have fun while we’re doing so. We are passionate about both our collegial atmosphere as well as working together on cutting-edge therapies that will change the lives of patients. We know we have a lot further to go, and we’re ready for the long haul.

Company info
Website
Phone
650-801-0474
Location
75 Shoreway Road, Suite D
San Carlos
California
94070
US

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