The Senior Director, Product Development Consulting works directly with senior management and business development to propose, defend, and then drive complex cross-functional development programs, generally through the management of a development team (eg, Molecule Development Team, Product Development Team, etc.) as the Program Manager. Works closely with senior management on the selection of team leader and the transition of that leadership at appropriate points throughout the overall development timeline. Involvement in preparing for and leading bid defense efforts for complex regulatory projects and development teams. Additional responsibilities include leading resolution of functional and cross-functional issues, cross-project and financial process improvements, and departmental initiatives; managing and/or mentoring project managers and teams on improving project performance; and taking on special projects as deemed appropriate by senior management.

Responsibilities:

• Manage complex cross-functional client-facing projects
• Involvement in leading proposal and bid defense efforts for complex regulatory projects and development teams
• Manage development teams inclusive of: creation and management of program level end-to-end integrated development plans, financial analyses, preparing for and leading client and internal meetings, issue and risk identification and resolution, resource management, cross-enterprise interactions and communications
• Participate in cross-functional internal and industry initiatives
• Contribute to materials for proposal templates and capabilities descriptions, and support business development staff training
• Identify, promote, and implement best practices, driving for sustainable competitive advantage
• As needed, provide management support for Regulatory Affairs and/or Regulatory Project Management staff.
• Lead special projects, as assigned by senior management
• Participate in and/or lead business development activities to increase business for overall regulatory services and enterprise development work
• Perform other duties as assigned by senior management

Education/Qualifications:
University/college degree (life science preferred), business, project management or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.

• Knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
• A good understanding of the drug development process.

Experience:

• At least 15 years of experience in the pharmaceutical industry with 7 years in Regulatory Affairs or in Drug Development.
• Demonstrated skills and competency in project management tasks
• Working knowledge of ICH Guidelines and GCP including international regulatory and clinical requirements for the conduct of clinical development programs.
• Ability to manage diverse cross-functional teams and deliver measurable results
• Excellent communication, facilitation and presentation skills
• Demonstrated skills and competency in proposal development
• Comprehensive understanding of processes associated with Global Regulatory Affairs activities
• Skilled in trouble-shooting and issue resolution
• Strong interpretation and analytical skills within and across projects / portfolios leading to documented efficiency improvements
• Experience in managing a project budget with documented cost containment strategies.
• Ability to work with minimal supervision.
• Good conflict management skills
• Good computer skills with a working knowledge of a range of computer applications.
• Excellent planning, time management and organization skills.
• Ability to work efficiently and effectively in a matrix environment.

Additional preferred experience:

• CRO/Pharmaceutical experience preferred, prior Labcorp Drug Development experience a plus
• PMP certification

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