Clinical Demand & Supply Leader

South San Francisco
California, United States of America


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The Position

The Clinical Demand & Supply Planning organization’s mission is to cost-effectively ensure the right product is in the right place at the right time every time, such that no patient will go without treatment and no clinical trial will be delayed. The Clinical Demand & Supply Leader (CDSL) is a supply chain expert assigned at the molecule level to ensure the entire portfolio of clinical trials are adequately supplied at all times, aligning activities with Technical Development Team (TDT) and Clinical Operations project milestones.  The CDSL translates clinical trial assumptions into drug forecasts and associated supply/distribution plans, initiates required activities & supply execution processes, and maintains oversight of the production, release, and distribution steps necessary to maintain a continuous supply of drug from FPI through completion of the clinical trial.

The CDSL is a standing member of the TDT and acts as the liaison between TDT and Clinical Operations/study teams.  The CDSL is the primary PTDS interface to our Clinical Operations customers, and is the contact for all strategic clinical supply related issues.

RESPONSIBILITIES

Demand & Supply Planning:

  • Manage supply in SAP/APO for a given molecule; including API/DS, Conjugation, Drug Product, Finished Goods, and OSD/Comparator procurement
  • Develop and communicate demand/supply plans throughout the organization to ensure alignment with TDT and various cross-functional teams; including production at SSF/KAU, at CMOs, or within the commercial network
  • Initiate the product definition process to ensure successful recipe & material master set-up for all items planned in SAP
  • Create, maintain, and validate clinical trial demand forecasts in CLARA/SAP based on assumptions provided by Clinical Operations
  • Forecast, plan, communicate, and initiate procurement of OSD/Comparator drug as required
  • Align final packaging design & production facility with key stakeholders, including TDT and Clinical Operations study team
  • Initiate label creation process and route Master Label for approval
  • Initiate, align, and update the IMP flowchart for each study to support regulatory filings
  • Primary PTDS representative to IxRS team, supporting the design & build documentation per trial
  • Manage both production and distribution orders for labeled IMP to ensure adequate inventory throughout the global depot network
  • Manage inventory levels, monitor expiration dating (initiate IMP shelf-life extension), and support stock-out tracking process for a given molecule
  • Adapt the supply chain/distribution strategy and IMP supply plan to match changes during course of a study, proving proactive analysis of risks, costs, feasibility
  • Ensure all regulatory & quality relevant changes for clinical trial material are taken into account within the supply plan

Supply Chain Expertise

  • Identify and incorporate areas of best practice and process improvement;  maintain oversight and ensure consistency across studies within a project with objective of enhancing quality, productivity, costs, and efficiency
  • Share best practice examples with global CDSL team

Partnering with Key Customers & Suppliers:

  • Proactively engage with Clinical Operations (OPL and/or Study Leader) to align on clinical development plan; regularly validate trial assumptions and review actual enrollment
  • Actively participate on TDT teams (and Device Teams) providing supply chain guidance and ensuring appropriate communication of current demand/supply plans, taking into account TDT project driven production requirements along with trial specific demand from clinical operations
  • Lead the cross-functional Global Supply Execution Team (GSET) to ensure alignment of key activities & timelines leading to the start-up and successful supply on each trial
  • Serve as the SPOC on study teams (ad hoc member) to communicate all forecast & planning activities up to technical release on IMP at the production sites; partner with GCDL to ensure all ongoing distribution issues appropriately addressed
  • Partner with internal PTDS functions (MPP, Label Development, Master Data, Distribution) along with external departments (Regulatory, Quality, Commercial Supply, Site Managers, etc.) to ensure timely execution of planned activities
  • Maintain collaborative relations with key external business partners to ensure effective communication demand & supply topics

QUALIFICATIONS

  • Bachelor's degree or higher, preferably in Life Sciences, Business (Economics, Operations Management, Supply Chain Management) or Engineering
  • MBA or advanced degree preferred
  • APICS CPIM, CIRM certifications a plus
  • 8+ years of related experience in Clinical Operations, Planning, Manufacturing, Quality, or other Supply Chain discipline, preferably in the Biotechnology / Pharmaceutical industry; minimum of 6 years with a Master’s Degree
  • Experience in global supply chain or related project team environment
  • General expertise using ERP systems, SAP/APO strongly preferred
  • Advanced understanding of drug development process, clinical trial design, drug technical development, drug demand forecasting and supply planning techniques
  • Strong knowledge of supply chain considerations (manufacturing, quality, analytics, regulatory, finance, clinical operations) for large molecules and small molecules
  • Strong analytical, logic and problem solving skills, with advanced knowledge of Excel
  • Proven ability to lead process improvement activities, delivering business processes and/or technical solutions satisfying multiple sets of stakeholders
  • Strong planning, organization, and time-management skills to juggle needs of multiple teams and projects simultaneously
  • Independent self-starter, with ability to lead ad hoc teams, perform work without supervision and show good judgment in determining objectives and approaches to assignments
  • Excellent verbal/written communication and presentation skills, including ability to simplify what is complex and focus audience on key messages
  • Extreme customer focus generating actions driven by internal/external customer needs and earning deep respect from customers
  • Ability to positively influence key decision-makers
  • Collaborative personality actively looking to make contributions to cross-functional teams

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Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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