Senior Director, GxP Development Systems

THE ROLE

The Senior Director of GxP Development Systems is a senior IT leadership role responsible for shaping and executing the digital systems strategy that enables Pioneering Medicines (PM) to build and scale world-class technical operations (TechOps), clinical development & quality capabilities. Reporting to the Vice President of Digital Platforms, this role will serve as the primary technology leader for Flagship’s clinical, regulatory, quality, and TechOps systems, partnering closely with the PM BRM, Clinical Leadership, and other cross-functional stakeholders.

The role will lead the Development Systems team within Flagship IT and oversee the implementation, operation, and lifecycle management of systems supporting clinical trials (e.g., CTMS, eTMF, EDC), regulatory operations (e.g., RIM), Quality (eg. QMS) and TechOps. This role is a critical bridge between technical enablement and clinical operations excellence and is accountable for ensuring these systems are fit-for-purpose, scalable, compliant, and aligned with both PM’s business needs and Flagship-wide digital architecture.

Strategic Leadership & Roadmap Development

• Contribute to the development and maintenance of the multi-year digital systems roadmap for clinical development, in partnership with the PM BRM and business process owners across Clinical, Regulatory, Quality and TechOps.
• Ensure the roadmap reflects strategic business priorities, regulatory requirements, and Flagship-wide platform strategy, and accounts for the need to implement robust and integrated systems.
• Champion the integration of data, applications, and AI into a cohesive development technology ecosystem.
• Guide vendor evaluations and platform selections in collaboration with Procurement, Cybersecurity, and PM leadership.

Program & Delivery Oversight

• Lead the successful implementation and scaling of TechOps, quality, clinical and regulatory systems across multiple programs and geographies.
• Ensure project delivery is timely, on-budget, and meets GxP, validation, and documentation standards.
• Oversee the Development Systems team and manage cross-functional IT resources assigned to delivery initiatives.
• Coordinate closely with the PMO and project managers to maintain initiative visibility, progress reporting, and risk management.

Operational Excellence & Lifecycle Stewardship

• Define operating models for support, change management, and enhancement of key development platforms (e.g., QMS, CTMS, eTMF).
• Partner with system owners and BPOs to ensure sustained operational support, compliance, and continuous improvement.
• Ensure platform health, including system validation, access control, and alignment with enterprise architecture and cybersecurity standards.
• Guide system decommissioning or migration as platforms evolve or are replaced.

Cross-Functional Engagement & Change Leadership

• Serve as a senior technology advisor to Clinical, Regulatory, Quality and TechOps functions.
• Act as a liaison between scientific and technical domains, translating business requirements into scalable solutions.
• Support business-led change management initiatives with technical insight, risk mitigation strategies, and IT alignment.
• Promote shared ownership and cross-functional accountability for digital success across PM.

PROFESSIONAL EXPERIENCE & QUALIFICATIONS 

• 15+ years of experience in IT or digital systems leadership in life sciences, with a focus on clinical development, regulatory operations, and/or quality systems.
• Demonstrated success implementing and managing GxP-regulated systems (e.g., CTMS, eTMF, EDC, RIM, QMS) either internally or through external partners.
• Experience leading cross-functional technology teams and managing complex projects involving multiple stakeholders.
• Proven ability to design and scale digital ecosystems that integrate applications, data, and AI and drive strong business value
• Strong knowledge of clinical trial processes, data standards, and regulatory requirements.
• Skilled in vendor and contract management, including SaaS platforms and managed service providers.
• Excellent communication and leadership skills with an ability to influence executive stakeholders.

Preferred Qualifications

• Prior experience in a biotech or fast-scaling clinical-stage organization.
• Knowledge of integration platforms (e.g., Workato, Boomi) and AWS-based data architectures.
• Familiarity with CMC technology and clinical supply platforms.
• Advanced degree in life sciences, information technology, or business administration.

ABOUT FLAGSHIP PIONEERING

Flagship Pioneering invents and builds platform companies, each with the potential for multiple products that transform human health, sustainability and beyond. Since its launch in 2000, Flagship has originated more than 100 companies. Many of these companies have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.  

Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. Learn more about Flagship at www.flagshippioneering.com.

At Flagship, we accept impossible missions to enable bigger leaps. Our core values guide us through uncertainty and toward lasting impact.

We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

We recognize that great candidates often bring unique strengths without fulfilling every qualification. If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your background and interest in Flagship.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

#LI-NM1