For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
The Senior Director, Program Management, Regulatory Sciences - Development is responsible for expertly leading large, complex, high-value cross-functional client programs, overseeing project delivery excellence across the Regulatory Sciences - Development Division, managing strategic client relationships, driving consistency in program execution, and leading and developing Regulatory Program Management team members. The role serves as a senior operational leader, ensuring effective planning, communication, governance, risk management, and delivery of client projects across Europe and Rest of World territories, while supporting selected global development programs. The Senior Director is accountable for establishing and maintaining program management standards, processes, and best practices across the organization.
Essential Functions
- Provide expert program and project management leadership across multiple complex client programs.
- Lead the development, implementation, and oversight of integrated program plans across regulatory, clinical, nonclinical, CMC, and other development functions and stakeholders.
- Strategically lead and deliver flagship client programs, ensuring efficient execution across all project phases.
- Establish program governance structures and lead cross-functional team meetings, executive reviews, and client steering committees.
- Ensure robust project planning, resource forecasting, risk management, issue resolution, and milestone tracking.
- Oversee project management activities in accordance with internal procedures, including budget monitoring, invoicing oversight, client liaison activities, and service growth opportunities.
- Lead key client relationships across multiple projects and service lines, ensuring consistently high standard of communication and project execution.
- Drive business growth initiatives, contributing to marketing activities and providing subject matter expert support to business development interactions.
- Lead and develop a team of Directors, Associate Directors, and Project Managers, including responsibility for coaching, performance management, resource allocation, and career development.
- Develop and implement program management standards, tools, templates, governance frameworks, and best operational practices.
- Stay informed of relevant program management methodologies, regulatory development practices, and project management technologies and contribute to industry workshops, trainings and calls for collaboration.
- Contribute to the ongoing improvement of internal regulatory processes and procedures.
Necessary Skills and Abilities
- Exemplary program leadership and organizational management skills.
- Exceptional stakeholder management and communication capabilities.
- Proactive leader taking responsibility and accountability for all assigned projects or tasks.
- Strong client relationship management and business development experience.
- Demonstrated ability to lead large, complex, cross-functional development programs.
- Talent development skills
- Excellent problem-solving, planning, analytical, and decision-making abilities.
- Ability to manage multiple competing priorities in a dynamic consulting environment.
- Strong financial acumen, including budget oversight and resource planning.
- Excellent negotiation, communication, and interpersonal skills, including executive-level communication.
- Strong attention to detail and commitment to quality and operational excellence.
- Ability to work collaboratively across geographically dispersed teams.
- Advanced proficiency with program management tools and reporting systems.
- Experience with Smartsheet strongly preferred.
Educational Requirements
- Advanced degree (MSc, MBA, PhD, or equivalent) preferred.
- Bachelor's degree in life sciences, healthcare, business, project management, or related discipline required.
Experience Requirements
- 15+ years of experience within pharmaceutical, biotechnology, CRO, or regulatory consulting environments.
- Minimum 8 years of experience leading complex cross-functional global development programmes.
- Demonstrated experience managing regulatory, clinical, nonclinical, and CMC workstreams within pharmaceutical development programmes.
- Significant experience leading client-facing project and programme delivery within a