Senior Program Manager (remote or onsite)

About COUR

COUR is a clinical stage biotech company that is developing technologies to revolutionize medicine and provide potential cures for auto-immune patients. Our innovative nanoparticle platform aims to address the root causes of autoimmune diseases, inducing tolerance and preserving overall immune functionality.



About the role

We are looking for an experienced Senior Program Manager to oversee the planning and execution of our pipeline programs that will revolutionize treatment for auto-immune patients. In this role, you will be responsible for managing one of our mission-critical, clinical stage programs.  

What you'll do

  • Program Management: Lead the strategic planning, execution, and monitoring of a novel, clinical stage drug program, ensuring alignment with corporate objectives, timelines, and budgetary constraints. 
  • Cross-Functional Collaboration: Collaborate closely with cross-functional teams including research and development, clinical development, regulatory affairs, and manufacturing teams to ensure seamless coordination and communication throughout the program lifecycle. 
  • Strategic Planning: Develop and implement comprehensive program strategies, including milestone planning, risk assessment, resource allocation, and contingency planning, to drive the successful advancement of drug programs from discovery through commercialization. 
  • Pipeline Management: Oversee the management and prioritization of the drug development pipeline, including portfolio analysis, decision-making processes, and resource allocation, to optimize the overall value and impact of the company's R&D efforts. 
  • Program Governance: Participate in established program governance structures, including project teams and decision-making forums, to facilitate effective communication, decision-making, and issue resolution across multiple drug programs. 
  • Risk Management: Proactively identify potential risks and issues within drug programs and develop mitigation plans to address them effectively, ensuring the achievement of key milestones and deliverables.
  • Documentation and Reporting: Maintain accurate program documentation, including project plans, status reports, project gantt charts, and presentations, and generate regular updates for senior management and key stakeholders. 
  • Compliance and Regulatory Affairs: Ensure compliance with regulatory requirements and industry standards throughout the drug development process. Manage all program specific regulatory submissions to the appropriate health authorities.

Qualifications

  • Bachelor's degree in life sciences, pharmaceutical sciences, or a related field; advanced degree (MS, PhD, or equivalent) preferred. 
  • 5-7 years of experience in program management within the pharmaceutical or biotechnology industry.  Demonstrated experience (ideally 5+ years) managing clinical stage drug programs (Phase II-III). 
  • Strong understanding of drug development processes, including pre-clinical research, clinical development, and regulatory affairs. 
  • Excellent leadership, communication, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and influence stakeholders at all levels of the organization
  • Proven track record of successful program management, including strategic planning, resource allocation, risk management, and decision-making. 
  • Proficiency in project management tools and software applications (e.g., Microsoft Project, Smartsheet, etc.).
  • Knowledge of regulatory requirements, industry standards, and best practices related to drug development and program management. 
  • PMP or equivalent certification is a plus
  • Strong preference for incumbent to be based at our Skokie office, but willing to consider remote candidates that are willing to travel to our office.

315 - R&D Program Management (Reg/Med Aff)

Skokie, IL

Remote (United States)

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