This newly created position will play a key role in establishing AMAGs program management processes and tools, risk assessment and mitigation and strategic planning with regards to resources, cross-functional plans and timelines across all programs. This role will initially focus on hands-on program managementfor AMAGs later stage (phase II and III) clinical projects. This will include ensuring that Clinical Development, Regulatory, Medical Affairs, and Manufacturingstrategies are integrated and aligned to deliver on the target product profile. . This role serves as an intermediary between these functions and also withthe Executive team, working through issues and ensuring that functional plans are harmonized and critical decisions are made in a timely manner. For each product candidate, this position will be responsible for facilitating the organizational understanding of cross-indication strategic choices and their implications, in order to optimize organizational decision-making for the molecule across indications.
- Assists in pipeline portfolio management by building AMAGs capacity for managing project plans, timelines and execution fromresearch through development and clinical stages.
- Assist cross-functional teams charged with overseeing specific tasks and stages of product development.
- Build detailed project plans based on the development plan to aid in successfully completing project objectives and goals asdetermined by the Company Executive Committee.
- Communicate with internal/external project stakeholders to ensure that corporate objectives for each program are met.
- Track and communicate project progress to the Executive Committee, and other individuals as specified by the projectobjectives.
- Assist the Executive Committee in developing project costs and integrating the project into the corporate budget and forecasting process.
- Analyze and communicate to the Executive Committee cross project, program, and portfolio impacts and risks as required.
- Assess the risk to successfully completing the project objective and deliverables based on technical, regulatory, and resource aspects for task completion. This will include developing mitigation and contingency plans for highest risk / highest probability issues and will enable the organization to respond to risks as they are realized in a seamless manner so as not todelay key program timelines.
- Developing project managers with integrated expertise in project management, end-to-end drug development and leadership competencies, and to ensuring effective and efficient departmental operations. Emphasis will be on development ofPM talent through direct management of project managers, as well as effective communication and collaboration with all stakeholder groups. The Executive Director will be accountable for performance of their staff consistent with objectives and expectations as well as ensuring the development of this next set of PM Leaders.
PREFERRED EDUCATION AND EXPERIENCE:
- Bachelor's degree required with a concentration in a scientific-related discipline strongly preferred.
- Advanced scientific degree (e.g., MS, PharmD, Ph.D.) or a combination of equivalent experience and training preferred.
- Project Management certification / training (PMP) and / or coursework & training in Project Management preferred.
Experience and Skills:
- With Bachelor's degree, desire 15 years+ of relevant job experience (pharma / biotech / PM). Years of experiencerequirement is relaxed for candidates with advanced degree, but must have 8+ years of experience in a PM or related role/expertise in pharma and / or biotech.
- Must have extensive experience with the planning and execution of strategies for drug / device product registration and commercialization / life-cycle management (can be R&D, manufacturing or commercial perspective) with demonstrated ability totranslate knowledge and expertise to other development teams and areas.