Manager, Clinical Supply Chain

We are a dedicated group of scientists, physicians, and businesspeople working together toward one goal: to discover and develop therapies that can unleash the power of the body’s immune system to treat and potentially cure cancer. We are passionate about the work we do every day at Agenus to deliver on the promise of immuno-oncology. If you’re looking for an inspired environment, passionate colleagues, and a culture that nurtures learning, innovation and team success, we invite you to join us.

In The Role You Will

• Create and update the clinical demand and supply plans and ensure alignment with timelines. Identify risks throughout the supply chain and implement risk mitigation plans.
• Drive continuous improvement and innovation in clinical systems and processes with the objective of enhancing quality, productivity, costs, and efficiency. Develop and maintain dynamic supply planning models appropriately adapted to the study phase.
• Prepare and update budgeted and actual spend for all clinical programs. Prepare SOW’s and associated purchase requisitions to meet project requirements and timelines. Manage PO issuance and adherence to budget.
• Develop a labeling strategy that meets regulatory and study requirements. Lead the development and approval of label text and label proofs including country-specific translations.
• Oversee the planning and execution of CMO activities and support issue resolution and continuous improvement.
• Support preparation of clinical study manuals/documents including the pharmacy manual, regulatory filings and QP declarations. Maintain required documentation related to study drug and supply chain activities in the Trial Master File.
• Manage GMP inventory (drug product, finished product) throughout the supply chain and ensure appropriate inventory levels are maintained. Develop inventory reports and metrics to support oversight of drug supply. Support import/export activities and track shipments to depots and clinical sites. Manage return and destruction of clinical supplies, with proper documentation of all steps.
• Lead end-to-end supply chain activities including, but not limited to, protocol interpretation, planning, distribution, inventory management, label generation and oversight of packaging/labeling and distribution activities internally and at our CMO’s.
• Manage the development and maintenance of Interactive Response Technology (IRT) and other systems used in managing supply for clinical studies.
• Manage the expiry strategy and ensure expiry extensions are provided to depot/sites as needed to support continued use of study drug. Plan over-labeling of study drug at depots/sites with appropriate lead time.
• Develop and update internal SOPs for supply chain GxP activities.
• Work collaboratively with cross-functional study team members to develop optimal supply strategies and ensure timely supply to patients while reducing risk and minimizing waste.

Qualifications: About You

• Experience in forecasting, demand / supply planning, IRT systems, inventory management, clinical packaging/labeling and distribution including cold chain, import/export and reverse logistics.
• Experience in managing outsourced business partners, including 3rd party manufacturing, packaging, warehousing & distribution
• Minimum 6+ years in bio/pharmaceutical industry, or combination of education and experience.
• Working knowledge of current GMP/GCP/GDP regulations.

Preferred Skills

• Proficiency with Excel modeling or other supply planning systems. Knowledge of clinical supply chain including packaging, blinding, randomization and IRT functionality.
• Knowledge of the ICH standards, as well as regulatory guidance documents such as Annex 13.

Education Requirements

• Bachelor’s Degree in Life Sciences, Business, Engineering, Supply Chain Management or related field. MS/MBA is desirable.

The targeted salary range for this position is $110,000- $143,100 per year. Agenus is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offered is commensurate with Agenus’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, critical needs of the role, and internal equity.

Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:

• Flexible Vacation Plan-In a time when we move at the speed of light, what matters most is what we achieve, not how many hours we clock or accrue. We want people to take breaks when they need them most and own their time. Our philosophy at Agenus is that freedom to take this time will lead to clarity, creativity and innovation through rested and refreshed eyes. With our Flexible Vacation Plan, Agenus will not limit the amount of vacation you can take. It will allow you to take the vacation time as you need, while fulfilling your job responsibilities and making meaningful contributions to our mission
• Free Parking
• Highly competitive and inclusive medical, dental and vision coverage options
• Education Assistance Program
• Care.com Memberships
• Employee Assistance Program
• 401k match and Financial Planning tools
• Employee Stock Purchase Plans
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Catered Lunch

Our core values

The way we work sets Agenus apart.

We put the patient first

We aspire to change the world, improving the experience and options available for every single cancer patient. The answers are out there, and patients are waiting.

We are bold, and we are one

We believe that the only way to deliver on our goals is to aim high and work as one global team. We look for opportunities to challenge, collaborate with, and support one another. We aim to break conventional standards and perform at extraordinary levels.

We work with integrity, respect and honesty

These three building blocks serve as pillars for how we behave, operate, and execute our mission.

We are a culture of ownership and accountability

We hold ourselves accountable not only for exceptional results, but how we get our results.

We are obsessively curious and deeply committed to learning

We live in a fast-paced environment that requires us to learn at or above the speed of change. We believe that curiosity fuels the desire to create, and learning provides the tools to progress.

We perform at our best every day

Every day counts. We confront insurmountable obstacles, problems and choices with intellect, perseverance and hard work.