Intarcia Therapeutics, Inc., is a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology, and have the potential to transform therapeutic categories.
We focus our efforts on serious diseases that are prevalent and poorly controlled. Our most advanced investigational product is ITCA 650 in type 2 diabetes (T2D). Currently in phase 3 development, this matchstick-sized titanium mini-pump is placed under the skin where it delivers exenatide continuously and consistently over 12 months. As such, this product fundamentally changes how therapy gets delivered by the healthcare system to patients, as well as how it is distributed and reimbursed. Our disruptive new approach holds significant promise as a 'game-changing' treatment in this increasingly common and important disease, and will require a new level of thinking and acting.
We Are Growing
Since the 2012 round of financing, much forward progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facilities, the opening of our new headquarters in Boston’s Innovation Center, and the diversification of expertise both on our Board of Directors as well as on our Leadership Team through newly acquired members who bring vital new capabilities with them.
A key element of pride during our progress has been our ability to remain fully independent through our rounds of financing so that we continue to have full strategic and executional control over our large global phase 3 clinical trial program, and all aspects of our rapidly evolving business plan. While we are obviously accountable to our stakeholders for progress, we are – and intend to remain – the driving vision and force behind our progress and our ultimate success.
As a key member of our Product Development team, the Clinical Supplies Project Manager, is responsible for the manufacture, packaging and distribution of clinical supplies for multiple Phase 1 through LCM studies conducted worldwide to meet Intarcia’s timelines and budgets and ensure no interruption of treatment or supply to clinical sites. The Project Manager will manage Intarcia’s vendors (labeling, packaging, distribution, and IVRS) to resolve issues and meet timelines and budgets. The Project Manager will be a member/leader of multiple project teams comprised of internal members and external contract vendors.
Duties and Responsibilities:
Develop and maintain timelines for project deliverables to ensure the availability and timely delivery of clinical supplies.
Coordinate with Intarcia’s clinical supply vendors to meet timelines and budgets.
Liaise with Intarcia’s internal manufacturing function to communicate clinical supply demands ensure supply.
Forecast clinical supplies and ancillary materials and ensure they are managed within set tolerances, including visibility of all stock levels and trigger points.
Maintain timelines and information tracking databases.
Review and update existing procedures and SOPs; identify the need for and assist in the establishment of new procedures and SOPs.
Provide ongoing support of the IVRS, including ensuring shipment accuracy and tracking, shipment strategy changes, shipment errors (communication between the IVRS & distribution CMO), inventory monitoring, and drug return strategy.
Generate clinical label text and design, coordinate label translation and the review and approval of clinical label proofs.
Compile all supporting batch documentation, perform technical packaging batch record review and ensure all batch records and other supporting documents are reviewed, approved and released by QA.
Participate in and maintain project-related budgets, review invoices and approve payments.
Develop or revise Standard Operating Procedures (SOPs) and guidelines related to inventory management, distribution, transportation, disposition of returned/unused materials
Prefer B.S. degree in Science (minimum).
Understanding of pre-clinical and clinical drug development of investigational new drugs or biologics, familiarity with FDA regulations and guidelines, including cGMPs, cGLPs, and cGCPs, and requirements for INDs and NDAs/BLAs
Exceptionally good interpersonal, verbal and written communication, and organizational skills.
A self-motivated team player with ability to motivate others in a team setting.
Ability to function efficiently, effectively and at times independently in a fast-paced, changing environment.
Ability to recognize and prioritize activities as related to Company programs and to formulate/implement appropriate strategies and actions to achieve Company goals.
Must have well-developed desktop computer skills, including familiarity with the use of word processing, spreadsheet, database, graphics and project management software
3 to 5 years direct project management in clinical supplies, working as a member/leader of a project team(s) utilizing internal resources and external contract vendors.