Mid sized pharmaceutical company with multiple stateside sites has an immediate need for a perm based in their Upstate NY facility (Albany/Troy area). Relocation assistance is available for the right out of town prospect. Details are as follows:
Using extensive CMC Project Management knowledge and experience in the drug development industry, the Manager/Senior Manager leads assigned CMC Projects that are typically of advanced complexity and large scope (such as Commercial or Late Clinical Phase in nature). The Senior Manager is expected to apply strong supervisory experience to lead and provide CMC expertise/guidance to assigned team members.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Leads the operational activities of cross functional teams and deliverables in a matrix organization in order to execute the development strategy for the assigned CMC Projects / programs. Drives the CMC Project / program’s evolution through completion within timeline, quality and budgetary constraints. Acts as a key resource for direct reports on matters related to CMC PM.
• Acts as a key liaison in the interactions between Company and our corporate partners. Prepares, provides input, and / or manages the process involving major presentations for joint collaboration meetings – effecting key business decisions. Responsible for facilitating and driving decision making in support of the joint strategic objectives of the program.
• Develops an integrated CMC Project plan relevant to the team deliverables and ensures alignment across relevant functions and smooth transitions among pipeline stages. Leads annual goal setting sessions to develop CMC Project level milestones that contribute to the overall milestones and for monitoring progress against these goals. Plans contingency and risk mitigation planning. Oversees the development of integrated CMC Project plans and actively monitors progress against the approved baselines.
• Demonstrates the ability to gain cooperation of others and effectively facilitates the resolution of cross-functional issues. Ensures effective, accurate and timely communication across functional areas within the CMC Project, serving as a primary point of contact for management within and outside the team regarding progress on CMC Project milestones. Communication responsibilities include but not limited to weekly/monthly project updates as well as project specific Technology Management Plans. Together with Department Director identifies and resolves any team and/or individual performance issues.
• Creates, maintains and executes CMC Project plans, timelines, agendas, resourcing requirements, rolling summaries, base lining and other tools required to facilitate planning and coordination of deliverables for each assigned CMC Project.
• Coordinates and leads communication between global functional areas and corporate partners where applicable. Coordinates activities for writing data summaries or presentations for joint collaboration meetings, etc.
• Proactively identifies issues and provides general guidance to resolve CMC Project issues and develops solutions to meet productivity and quality milestones and objectives.
• Develops tools and mechanisms for monitoring progress and problem solving with CMC Project and functional area managers. Defines and documents working / best practices that can be used across other CMC Projects with all relevant departments in order to ensure that product is efficiently supplied to all non-clinical, clinical, and commercial sites.
• Requires a demonstrated ability to change the thinking of, or gain acceptance of others in sensitive situations and influences the overall objectives and long-range milestones of the CMC Project / program. Represents the department in relevant internal / external committees. Coordinate the CMC regulatory activities required for submission of license applications, INDs, and other regulatory documents to government agencies.
• Ensures quality and timeliness of deliverables for projects are met.
• Lead special projects as assigned by supervisor/department management.
Knowledge, Skills, and Experience:
• Consistently demonstrates strong interpersonal skills and consistently nurtures productive relationships with internal and external customers.
• Initiates and leads the decision-making and risk-management process. Trouble shoots and is proactive in dealing with EM-vendor / collaborator issues for individual and teams projects.
• Ability to effectively deal with ambiguity and change.
• Understands and motivates others and builds effective teams. • Requires strong presentation and critical thinking skills.