Senior Director, Programme Management, Regulatory Sciences - Development

For the past 25 years, Pro Pharma 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.

Pro Pharma 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, Pro Pharma 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, Ph D, 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 consultancy environment preferred.
• Proven track record of successfully leading and delivering high-impact projects within budget and timeline expectations.
• Previous experience leading project management, programme management, or PMO teams.
• Experience establishing programme governance frameworks, risk management approaches, and delivery excellence initiatives.
• Demonstrated experience supporting business development activities and strategic client growth.
• Experience with Smartsheet portfolio management, dashboard development, resource planning, and reporting preferred.
• Experience overseeing Europe and Rest of World regulatory development programmes required; global programme leadership experience preferred.

We celebrate our differences and strive to create a workplace where each person can be their authentic self.

We are committed to diversity, equity, and inclusion.

Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.

With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at Pro Pharma are personally reviewed by a member of our recruitment team.

We do not rely on AI screening tools to support our hiring process.

You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst Pro Pharma supports remote working, we also recognise the value that comes from in person collaboration.

As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager.

All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***Pro Pharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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