Director of Program Management – R&D Cross-Functional Drug Development

SUMMARY:

The Director of Program Management will be responsible for providing cross functional program management support and capacity planning guidance for pharmaceutical development teams. This individual is responsible for managing activity planning as well as project execution in various areas including nonclinical, manufacturing, clinical, regulatory, and quality. The Project Manager will play a critical role in planning, coordinating, implementing, executing, and supporting teams for various projects and working with internal and external stakeholders. This position shall adhere to the Company’s quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in this job description.

ESSENTIAL FUNCTIONS:

• Establish, maintain and track integrated project plans, budgets, and resources needed to deliver against company goals.
• Effectively partner with internal stakeholders to identify resource and business constraints and avoid scheduling conflicts in the presence of multiple priorities competing for limited resources over the planning horizon.
• Conduct scenario planning activities for high level drug development plan strategies & provide strategic decision-making data to senior leadership to drive strategy execution.
• Prepare regular project status reports, identify key issues and action plan updates for project meetings.
• Identify ways to accelerate project execution where possible while maintaining high quality standards and cost efficiency.
• Create and maintain the overall project budget through close collaboration with Finance and external partners.
• Monitor performance and recommend scope, schedule, cost or resource adjustments while considering short term demands and long-term implications.
• Identify and lead opportunities for business process design and improvements.
• Employ excellent interpersonal, communication and negotiation skills with all levels of personnel and management to facilitate information flow between departments and senior management.
• Perform duties on site, on time, and within the company operating principles. Facilitate frequent interactions with co-workers and conduct timely problem-solving meetings necessary to address critical and emerging work issues. Present a positive attitude to create and maintain productive working relationships with fellow employees and vendors.

EDUCATION:

• Bachelor’s Degree in a scientific or technical discipline
• Master’s degree preferred
• PMP Certification preferred

EXPERIENCE:

• 8+ years project management experience in a pharmaceutical or biotechnology industry.
• 8+ years of relevant experience in the pharma/ biotech industry.
• Exposure to CDMO or CROs strongly preferred.
• Exposure to Regulatory submissions or major Health Authority requirements and processes preferred including a broad understanding of BLA requirements is important
• Demonstrated experience with MS Project or Smartsheet, SharePoint, Office Timeline /OnePager or similar software systems/platforms
• Project management experience in gene therapy or large molecules preferred.
• Familiarity with GxP regulations a plus

SKILLS:

• This is a dynamic, empowered, collaborative and mission-driven setting. In addition to technical requirements noted above, we seek a smart, insightful, self-directed and competent professional who can gain the respect and cooperation of colleagues and partners in order to achieve shared success. Strong communication skills will be essential.
• Must have experience with advanced problem-solving and change management methodologies consistent with establishing a culture of continuous improvement.
• Demonstrated leadership skills and proven ability to work collaboratively between departments.
• Ability to handle conflict through proactive action and direct and timely communication.
• Strong interpersonal skills, effective problem solving and decision-making skills.
• Proven ability to quickly earn the trust of sponsors and key stakeholders and mobilize and motivate teams.
• Strong analytical, problem solving, critical thinking, and financial planning skills.
• Hands on experience utilizing project management tools and software solutions.
• Well-organized professional, with strong verbal and written communication skills.
• Demonstrated ability to handle multiple competing priorities and work in a fast-paced environment.

All interested applicants should send a cover letter and resume to [email protected]