Senior Manager, Clinical Supply Chain (South San Francisco, CA)

Sutro Biopharma, Inc. is looking for a Sr. Manager, Clinical Supply Management who will be responsible for clinical supply chain operations in various phases. A successful candidate will demonstrate leadership ability, end-to-end clinical supply chain expertise (managing all aspects of clinical supplies in a global trial setting), be able to work independently and enjoy working in a dynamic, fast-paced environment during a period of significant growth.

Responsibilities

  • Manage all clinical supply activities for on-time delivery, which includes demand forecasting, resupply planning, packaging, distribution, and input into Interactive Response Technology (IRT) set-up..
  • Strategically manage procurement, packaging, labeling, distribution, returns, reconciliation, destruction and storage tasks for all clinical trial materials.
  • Review and approve documentation related to packaging, labeling, and distribution of clinical trial materials. Maintain appropriate documentation in compliance with domestic and international regulations.
  • Manage clinical trial materials distribution and logistics for global clinical programs, including importing and exporting clinical supplies.
  • Support the procurement, labeling and distribution of comparators.
  • Work collaboratively with Clinical Operations, Partner Alliance/Project Management, Quality Assurance and Regulatory Affairs to develop supply strategy to maximize supply efficiency, minimize waste, and develop risk mitigation plans to proactively identify any potential issues that may impact drug supply.
  • Manage study closeouts and drug reconciliation at study end.
  • Develop and manage clinical supply budget and negotiate contracts with vendors.

Qualifications

  • Requires a BS degree with a minimum of 5 years’ experience in a clinical supply chain management role in a biotechnology/pharmaceutical industry.
  • Experience managing contract packaging and labeling organizations.
  • Experience with developing risk-based Clinical Trial Supplies management from early to late phases international clinical studies (preferred).
  • Experience with VAT reclaim process (preferred)
  • Manage vendor oversight activities and vendor performance to ensure high-quality, cost-effective execution of outsourced clinical supply activities.
  • Detailed understanding of regulatory requirements for clinical supply distribution in (minimally) US, APAC, and EU including labeling requirements.
  • Detailed understanding of regulatory and Good Manufacturing Practices and Good Distribution Practices requirements for IMP supply and national/international transportation requirements for pharmaceutical materials.
  • Global distribution experience including working with QP and regional depots.
  • Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient
  • Excellent project management and communication skills
  • 10 to 15% travel may be required (including international travel).

Sound exciting? Apply today and join our team!

Please submit resume for Req. #2280 to jobs@sutrobio.com. Please visit our website at www.sutrobio.com for more information.

Sutro Biopharma, Inc. requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Sutro will consider requests for reasonable accommodations.

Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.

As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability, or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.

Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.

We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.

Company Overview

Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development, and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.

Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro’s platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines, and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal.

The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.

In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.