Manager II, Clinical Supply ChainIrvine, California, United States

Manager II, Clinical Supply Chain

This position is responsible for the overall clinical study planning, clinical packaging and labeling, and distribution of investigational drug product (IP) as governed by our standard operating procedures, assuring compliance with Good Distribution practice, ensuring compliance with customs regulations as required. This position will participate in and contribute to cross-functional meetings and collaborate with all pertinent functions to meet clinical trial timelines and oversee the shipment schedules to ensure IP availability for all sites and patients.

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

• Overseeing/managing end-to-end clinical drug supply chain including the planning, packaging and labeling, distribution, returns, reconciliation and destruction of DP and IP.
• Planning and forecasting for global clinical drug supplies for various programs, supporting all phases of clinical trials while maintaining compliance with regulations for all countries.
• Reviewing, interpreting and translating the clinical protocol into the clinical supplies demand requirement.
• Participating in CORE Team meetings, Clinical Trial Team meetings, CMC Team meetings and other ad-hoc meetings, as required for representation of Clinical Supply Management function.
• Partnering with key stakeholders (e.g. Quality Assurance, Regulatory Affairs, etc.) to ensure supplies are appropriately packaged, labeled and released for shipment.
• Design and/or review label text and facilitate the translations to meet country specific requirements and ensure compliance with US and international labeling regulations.
• Overall management of Drug Product and IP inventory at depots and clinical sites to ensure zero stock out and 100% drug accountability.
• Expertise in and interfacing with RTSM vendors to review, process, set up scripts and participate in user requirements testing (UAT) and execution of system to manage randomization, supply distribution and patient tracking.
• Monitoring re-evaluation & expiry dating of drug supplies and comparators, including re-labeling activities at depots and sites.
• Work with internal and external Logistics personnel to ensure on-time delivery of clinical supplies shipment to, from or between CDMOs/CMOs, depots/3rd party depots, investigator sites, and other vendors, as appropriate.
• Monitor, evaluate and process temperature excursions during transit and storage at depots and sites.
• Responsible for generating the change controls, deviations, specifications and other document uploads within internal QMS system for their studies and programs.
• Collaborate with cross-functional teams per the following:
• CMC: Work with CMC to ensure manufacturing schedules and forecasts are aligned to meet clinical needs, monitor CMO's timely production and issue resolution.
• Quality Assurance: Work with QA Ops and Quality Compliance to coordinate document reviews and approvals, timely release of drug products and packaged investigational products and on-time distribution to CPOs and clinical sites.
• Clinical Development/Operations: Collaborate with Clinical Development/Operations for study design, planning, demand/forecast; finalization of Clinical Supplies Planning Agreement.
• Regulatory Affairs: Obtain guidance on label text & translations and site start up activities as it pertains to DP/IP to ensure compliance with regulations and ethical standards.
• Biostatistician: Collaborate on RTSM design, study sample size, randomization and kit list, blinding procedures and other statistical activities.
• Supply Chain/Logistics: Coordinate the timely and secure movement of DP/IP while complying with GDP and GCP to maintain integrity and safety.
• Legal/contractual: Enforce contractual commitments.
• Finance: Assure that the financial terms and conditions of the Tarsus-CMO/CPO relationship are being met by both parties.
• Ensure collaborative relationships internally resulting in sufficient inventory, timely supply release, issue resolution and 100% drug accountability.
• Manage drug supply returns, accountability and destruction.
• Other supply chain function, as needed.

Factors for success:

• Bachelor's degree in Supply Chain Management, Clinical Supplies or Scientific related field.
• 8 years of experience in clinical supplies and logistics, in the pharmaceutical/biotechnology industry.
• Experience in cGMP/GDP and regulatory regulated environment (Pharma, combination product, Biotech, Med device, solutions, solid dosage or semi-solid dosage form, etc.)
• Oracle NetSuite or other ERP supply demand management tools.
• Experience leading multiple projects simultaneously across a matrixed organization in a fast growing/fast moving company with an international and growing supply chain.
• Ability to come up with an overall strategic plan and execute on the tasks.
• Ability to understand timelines and when each tasks needs to be done.
• Exceptional attention to detail, ability to effectively communicate with others, good customer service skills and ability to think critically and solve problems quickly and accurately.
• Ideal candidate is organized, has excellent communication skills, sense of urgency and is able to adapt to a rapidly changing environment.
• Proficient with RTSM/IRT application/system experience.

A few other details worth mentioning:

• The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our Sr. Director, Supply Chain.
• Some travel may be required up to 15%.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $116,200 - $162,800 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days.