Program Manager - Biotech

JOB DESCRIPTION: We are seeking a highly skilled and experienced Program Manager to oversee multiple pre-clinical and clinical stage drug programs within our organization. The Program Manager will play a pivotal role in driving the successful progression of these programs, from early-stage research through clinical development, regulatory approval, and commercialization.
 

Responsibilities:

• Program Management: Lead the strategic planning, execution, and monitoring of multiple pre-clinical and clinical stage drug programs, 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: Particiapte 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 (PhD, MBA, or equivalent) preferred.
• Minimum of 3 years of experience in program management, project management, or related roles within the pharmaceutical or biotechnology industry, with demonstrated experience managing multiple pre-clinical and clinical stage drug programs.
• 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.