Work at Tarsus

Manufacturing

Director, Clinical Supply Chain


Tarsus is looking for inspired individuals who are interested in growing their career while helping us advance our mission to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care.

Who is Tarsus? We are a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address diseases with high unmet need.

Tarsus is developing a pipeline of medicines and our lead product candidate, TP-03, is in a Phase 3 and second pivotal trial for the treatment of Demodex blepharitis (DB). TP-03 has the potential to be the first FDA-approved therapeutic and the standard of care for the treatment of Demodex blepharitis, a common lid margin disease that may affect up to 25 million people in the U.S. Significant commercial strategic planning is currently underway for TP-03. We are also developing TP-03 for the treatment of Meibomian Gland Disease, TP-04 for the treatment of Rosacea, and TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease.  TP-03 and TP-04 are expected to be in Phase 2a studies in 2022, and TP-05 is currently being studied in a Phase 1b clinical trial.

Join us in advancing our pipeline to address a number of diseases across therapeutic categories including eye care, dermatology, and other diseases with high unmet needs

Let’s talk about some of the key responsibilities of the role:

The Director of Clinical Supply Chain collaborates across the organization for development and clinical supply chain solutions to optimize the supply chain function. In this role, you will collaborate and help develop plans for product availability, optimization and efficiency improvement and will follow-up until implementation is complete. You will also be accountable for improvements in the company’s TP-03, MGD, TP-04, TP-05 and future development and late-stage clinical trial material (CTM) or development product availability, including packaging, labeling, kitting, and managing IVR systems, temperature trace monitors and shipping documentation, clinical supply depots and logistics.


Key Responsibilities

  • Lead key aspects of Clinical Supply Chain (CSC) projects working directly with the supply chain and manufacturing/tech ops, CMC, and quality teams to plan and execute on defined scope, budget, and transformation results
  • Lead Materials Inventory Planning, Logistics & Good Distribution Practices (GDP), clinical labeling and packaging CGMP compliant and phase appropriate CSC activities and will strategically develop, manage, and lead temperature-controlled storage and distribution globally supporting a complex controlled supply chain network. Leads Global Clinical Supply Chain distribution,

engineering for a rapidly growing specialty pharmaceutical organization, including clinical packaging and distribution with CMOs, CPOs, label vendors, and clinical and development supply warehouses and external partnerships worldwide. Additionally, this role serves as the process lead for GDP compliance across development and CTM supply chain network.

  • Responsible for collaborating cross functionally with CMC, Manufacturing Technical Operations, Clinical Operations, Quality Assurance, Alliance and Project Management, Finance, and Corporate Compliance to ensure planned and predictable distribution services are provided to internal partners, external partners/external customers of Tarsus.
  • This function is critical to the overall results of customer satisfaction, inventory integrity, and supply chain management.

The position reports to the Vice President, Manufacturing Operations and Supply Chain Management. The incumbent must act quickly and decisively to assess urgent situations concerning customer requests, and act accordingly to provide immediate attention, correction, and execution of solution. Must continually stay abreast of export/import and regulations to insure GDP compliant movement of product in the US and worldwide.

Clinical Supply Chain Management

  • Lead the development, approval, and execution of CSC planning, material and inventory control, logistics solutions, CROs, CDMOs, CMOs, clinical packagers, labelers, clinical depots. Lead US and worldwide shipping and distribution of Tarsus clinical and development products through collaboration with QA, Compliance, and Manufacturing Tech Ops, Supply Chain / CMC personnel. Will corroborate with commercial supply chain to align as appropriate with timing, availability, scale, frequency, cost, and other SC aspects.
  • Serve as technical expert for aspects of clinical packaging, labeling, and shipping logistics (forward and reverse logistics).
  • Assess temperature and physical protection requirements for Tarsus products and work cross-functionally to implement solutions. This would include managing the relationship with suppliers and inventory of materials at the CSPs, CPOs, and warehouses.
  • Provide support for shipping activities. Drive CSP initiatives and lead implementation of enhanced processes and solutions.
  • Responsible for the investigation and resolution of in transit temperature or inventory discrepancies.
  • Conduct vulnerability analysis for goods in transit, considering such factors as risk, impact, and criticality.

 

Continuous Improvement and CSC Operational Excellence

  • Collect, assemble, analyze SC cost data, and make recommendations regarding clinical packaging, labeling, clinical depots, controlled temperature distribution and storage solutions.
  • Apply expert knowledge of GDP compliance and inventory management in delivering logistics process oversight in the development, clinical supply chains.
  • Perform oversight of clinical depots and warehouses, quality management systems; facilities, equipment; coordination processes and documentation.
  • Maintain and manage risk-based model for management of GDP activities
  • New clinical trials materials and clinical trials at different phases and locations represent a significant challenge for this position. 
  • Establish an objective measurement of the usefulness of the CTM demand plan, CTM supply plan and fulfillment processes and make recommendations for change aligned to clinical and business needs.
  • Establish inventory health metrics to support corporate targets.
  • Establish mechanisms to achieve Key Performance Indicators to drive business results, including leading indicators which will serve as early warning signs of problem performance for contract service providers (CSP) performance.
  • Work with IT, PM, and other departments to identify and standardize around a core set of information system solutions and data analytics platforms.

Qualifications And Experience

  • Bachelor’s Degree in Supply Chain Management, Industrial Engineering, or related field is required. Master of Business Administration (MBA) or other advanced degree or formal project management, APICS and/or Lean & Six Sigma certifications are preferred.
  • 15+ years of relevant clinical supply chain experience, ideally with at least 5 years of people management experience and growing virtual company environment.
  • Experience in cGMP/GDP, SOX regulated environment, preferred (Pharma, Combination Product, Biotech, Med Device, etc.).
  • International clinical supply chain and logistics experience utilizing warehouses and clinical depots, or clinical distribution centers preferred. Phase 1-4 clinical supply chain experience preferred.
  • Consistent record for developing, training, and mentoring employee teams in a continuous improvement environment
  • Oracle NetSuite (preferred) and applicable clinical supply planning tools such as IVRS or applicable experience.
  • Clear understanding of the CTM process in manufacturing businesses, with the ability to understand critical business systems, tools, and processes to ensure an accurate and meaningful CTM forecast for clinical success.
  • Experience working with and leading multiple projects, dosage forms, and teams simultaneously across a matrixed organization in a start-up, fast growing/fast moving company with an international and growing supply chain. Because we are a growing organization, other duties may be assigned.

 

A Few Other Details Worth Mentioning:

  • The position will be based in our beautiful Irvine office, complete with a courtyard, table tennis, snacks and drinks, occasional catered meals, and pet-days. If agreed, the position can be remote/hybrid with expected travel to Irvine office and/or CDMOs, CMOs, CPOs, and clinical depots and CTM distribution sites as needed.
  • This position reports directly to the Vice President, Manufacturing Operations and Supply Chain Management
  • Some travel may be required – 30-40% (depending on COVID-19 situation)

Equal Employment Opportunity Employer

At Tarsus Pharmaceuticals, we value bringing together individuals from diverse backgrounds to drive better results for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Equal Employment Opportunity is the law, and you can find more information here. If you are an applicant and would like to request an accommodation, please email careers@tarsusrx.com.

Manufacturing

Director, Clinical Supply Chain


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