Position Summary

Tesaro is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients by developing and providing safer and more effective therapeutics and supportive care products.

Reporting to the Vice-President, R&D Operations the CMC Project Manager will provide chemistry, manufacturing and control (CMC) cross-functional strategic direction and tactical management for one or more of Tesaro’s global development programs. The candidate will establish and lead technical subteams to build and execute CMC strategies integrated with the overall program objectives and timelines. S/he will work with internal and external stakeholders to define, manage and interpret results for CMC related activities in support of global clinical development and registration. The individual may serve as the CMC area technical expert on program teams and is responsible for setting CMC objectives, budgets, and timelines in alignment with registration strategies. S/he may facilitate knowledge transfer of licensed assets.

Responsibilities

• Regularly meets with CMC functional leads to define strategies and manage tactical execution and links discrete CMC strategies into a single, comprehensive strategy across the areas of drug substance, drug product, analytical, clinical supply chain, regulatory and quality; actively integrates the needs of the overall development program with CMC
• Regularly meets with the VP R&D Operations to review recent results, set next plans, and assure appropriate progress is being made on assigned programs
• Establishes and leads cross-functional CMC teams for assigned programs; prepares for and runs regularly scheduled meetings; provides technical project management including elements such as Gantt and budget development, critical path analysis and risk mitigation
• Partners with CMC leads to define the global CMC requirements (and their timing) to meet proposed clinical development plans, and international product registration submissions including follow up with deliverables on action items and recording decisions and their rationale
• Provides critical analysis of program challenges and opportunities and recommends mitigation plans where necessary
• As appropriate, supports preparation of RFPs and assesses technical capabilities for vendor selection; may perform technical audits of CMC vendors and may provide oversight and technical management of certain contracted CMC activities
• Provides leadership to ensure scientific excellence in study design, data collection and interpretation, and management within scope to prospectively agreed objectives, budget and timelines
• Together with the CMC subteam, prepares and keeps current written CMC development strategies in alignment with overall program objectives and will present results and progress of CMC programs to internal and external audiences as appropriate
• Provides expert scientific or QC review of CMC sections of regulatory documents and may provide drafts for needed CMC-regulatory amendments

Education/Experience Requirements

• Requires a BS degree and minimum 8 years of relevant experience, including experience as a project manager and pharmaceutical functional area scientist; or a MS degree and minimum 5 years of relevant experience
• Proven leadership and cross-functional management of CMC projects
• Demonstrated leadership in more than one CMC specialty and extensive experience with vendor management
• Strong technical/analytical skills to identify and solve problems
• Working knowledge of cross-functional drug development processes, FDA/ICH/EMA guidelines and cGMPs
• Working knowledge of CMC development strategies across IND-NDA stages
• Experience in preparation and submission of CMC documents in support of regulatory filings
• Demonstrated project management experience and skills, with the ability to coordinate multiple projects
• Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company, vendors, and contract sites
• Working knowledge of global requirements for IND and NDA submissions (or their regional equivalents)
• Strong organizational skills in order to maintain a high level of productivity, innovation, and setting priorities in order to complete assignments in a timely manner and within budget
• Exhibits high initiative, strong drive and follow-through in a fast-paced, dynamic environment
• Competency in MS Office, MS Project