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Associate Director CMC PM

Company: Regeneron Pharmaceuticals, Inc.
Location: Troy
Posted on: May 12, 2022

Job Description:

We are currently looking to fill an Associate Director CMC PM position. Using extensive CMC Project Management knowledge and experience in the drug development industry, the AD provides operational leadership, direction and support to CMC-PM team members. Individual may also manage CMC Projects that are generally of sophisticated complexity and large scope (such as Commercial or Late Clinical Phase in nature). As a leader the individual consistently demonstrates strong interpersonal skills and consistently cultivates productive relationships with internal and external customers. The AD provides experienced guidance and mentorship with regards to CMC-PM to team membersIn this role, a typical day might include the following:

  • Facilitates achievement of strategic project milestones and supports, through active and consistent leadership, department operational objectives. Monitors ongoing progress of key deliverables against global development plan milestones, including the identification of potential risks and contingency plans. Acts as a key resource for direct reports on matters related to CMC PM.
  • Acts as a key liaison in the interactions between Regeneron 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.
  • Supports and Implements the standardization of processes and communication tools in order to build efficiencies within the department.
  • Exhibits a degree of ingenuity, creativity and resourcefulness in a sometimes evolving and ambiguous environment. Shows resiliency in the face of challenges and adversarial situations. Exhibits confidence and a realistic sense of self awareness in own strengths and weaknesses.
  • 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 achievements that chip in to the overall achievements 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 collaboration 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 achievements. Communication responsibilities include but not limited to Manage Supply, weekly/monthly project updates as well as TMPs. Works with the team leader to identify and resolve any team and individual performance issues. Together with Department Director identifies and resolves any team and/or individual performance issues.
  • Develops COMPASS key deliverables and CMC Project dossier items. Identifies and implements new solutions to improve tracking, planning and collaboration.
  • 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 solutions to resolve CMC Project issues and develops solutions to meet productivity and quality achievements and objectives.
  • Develops tools and mechanisms for supervising progress and problem solving with CMC Project and functional area managers. Defines and documents working / standard methodologies 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
  • Regularly interacts with Sr. Management or executive levels on matters concerning several functional areas. Requires the ability to change the thinking of, or gain acceptance of others in sensitive situations and influences the overall objectives and long-range achievements 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. Adept at managing multiple projects/tasks simultaneously, switching between tasks quickly, and juggling competing priorities and projects.
  • Lead special projects as assigned by the Department Director/Sr. DirectorThis role might be for you if:
    • Possess excellent written, verbal and interpersonal skills and the ability to effectively interact with all levels both within and outside the company to establish credibility with professionals on the CMC program teams.
    • Excel at resolving and mitigating conflicts or problems with tact, subtlety and composure.
    • Enjoy balancing multiple CMC projects and priorities with outstanding organizational and time management skills (both CMC project and self).To be considered for this role you must hold: Bachelors, Masters or Doctorate in any physical or Biological Science. 10+ years (with BA/BS), 8+ years (with MA/MS or Ph.D) of relevant progressive CMC Project Management experience. Experience successfully leading a team in the drug development industry.Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Keywords: Regeneron Pharmaceuticals, Inc., Troy , Associate Director CMC PM, Executive , Troy, New York

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