Do you have the passion to join a young global bio-pharmaceutical whose sole mission is to improve the lives of patients bravely facing cancer? Does it excite you to be a part of a rapidly expanding company with multiple marketed products and a diverse and robust pipeline? If yes, you may be a great fit for our community of dedicated and innovative associates.
Your impact at TESARO:
Responsible for operational leadership of cross-functional CMC project sub-team(s). Ensure that the CMC project(s) are defined and implemented per the defined strategy and work closely with the technical CMC Lead to build, implement and execute the CMC project strategy and plans. Work with internal and external stakeholders to define, manage and interpret results for CMC-related activities in support of global clinical development and registration.
• Provide CMC operational leadership, tactical oversight, and guidance to program teams and management to support global program development. • Work with the CMC Lead and cross-functional area experts to develop CMC strategies and design development work or studies. • Manage the integration of defined CMC activities within CMC sub-teams and with the overall program development teams. Operationalize the CMC strategy and keep the team aligned. • Build detailed CMC timelines with clarity to assumptions, risks and decision points. • Support CMC area objectives, budgets and resource plans. Manage the CMC budget for programs through collaboration with consultants, contractors, and internal associates. • Work with CMC functional leads to review strategies and manage tactical execution. Link discrete CMC strategies into a single, comprehensive strategy across the areas of drug substance, drug product, analytical, clinical supply chain, regulatory and quality. • Establish and lead cross-functional CMC teams for assigned programs. Provide technical project management including Gantt and budget development, critical path analysis and risk mitigation. • Partner with CMC leads to define the global CMC requirements (and their timing) to meet proposed clinical development plans and international product registration submissions. • Support preparation of RFPs and assess technical capabilities for vendor selection; may support technical audits of CMC vendors, as well as oversight and management of contracted CMC activities.
• B.S. with 8+ years or M.S. with 5+ years of relevant experience as a CMC project manager and/or pharmaceutical functional area scientist. • Proven leadership and cross-functional management of CMC projects, including demonstrated leadership in more than one CMC specialty, and extensive experience with vendor management. • Travel (some international) may be required. • Ability to run multiple cross-functional teams at one time to support the CMC portfolio. • In-depth knowledge of cross-functional drug development processes, FDA/ICH/EMA guidelines and cGMPs. • Working knowledge CMC development strategies across IND-NDA stages and of global requirements for IND and NDA submissions (or their regional equivalents). • Experience in preparation and submission of CMC documents in support of regulatory filings.
TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Internal Number: 1800006T
Do you have the passion to join a young global biopharmaceutical whose sole mission is to improve the lives of patients bravely facing cancer? Does it excite you to be a part of a rapidly expanding company with multiple marketed products and a diverse and robust pipeline? If yes, you may be a great fit for TESARO and our community of dedicated and innovative associates.