Director, Development Systems

Flagship Pioneering is a bioplatform innovation company that invents and builds platform companies that change the world. We bring together the greatest scientific minds with entrepreneurial company builders and assemble the capital to allow them to take courageous leaps. Those big leaps in human health and sustainability exponentially accelerate scientific progress in areas ranging from cancer detection and treatment to nature-positive agriculture. What sets Flagship apart is our ability to advance biotechnology by uniting life science innovation, company creation, and capital investment under one roof in a way that is largely without precedent. Our scientific founders, entrepreneurial leaders, and professional capital managers are each aligned around an institutionalized process that enables us to innovate and transform for the benefit of people and planet. Many of the companies Flagship has founded 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. Position Summary: The Director of Development Systems holds a crucial role in elevating the standard of digital solution design & delivery and system ownership within Flagship IT in partnership with Pioneering Medicines. This role will be the digital delivery leader for functions spanning Clinical Development, Clinical & Regulatory Operations, Translational Medicines, and Technical Operations. The leader of Development Systems will partner with those groups to develop and execute against functional technology roadmap(s), support existing enterprise applications such as the electronic Quality Management System (eQMS), and ensure effective and secure data exchange with external service providers. The leader in this role will be expected to cultivate and maintain strong relationships with technology and consulting vendors in the development systems business areas (Clinical, Regulatory, Biostatistics, Quality & CMC), ensuring that the organization is at the forefront of regulatory, clinical, and quality system advancements. Through these partnerships, the Associate Director/Director will spearhead the integration of technologies and methodologies that drive efficiency and compliance across all levels of the organization. Key Responsibilities: Lead the analysis, design, prioritization, and implementation of digital products, platforms, and services, aligning them with business strategies and regulatory compliance. Take the lead in instilling a product management mindset across digital operations for Pioneering Medicines. Direct technical teams and service delivery with a focus on efficiency, quality, and compliance. Assume system ownership responsibilities, maintaining and enhancing critical systems such as eQMS, RIM, and eTMF to ensure they remain compliant (i.e. inspection-ready), efficient, and integrated with business operations. Develop strong relationships with technology vendors, particularly in the domain of clinical operations, to advance digital development systems. Support the development of technology roadmaps following value stream concepts, ensuring coherent and integrated product strategies. Ensure digital products and systems are scalable, compliant, and aligned with business strategies. Collaborate with various functions to finalize product specifications, resource allocation, roadmap, timelines, and manage the development process. Collaborate with Flagship Digital and other stakeholders to optimize value with digital and data science initiatives (i.e. AI), ensuring that Pioneering Medicines' digital strategies align with the broader organizational goals and objectives. Ensure that Pioneering Medicines' digital initiatives are scalable, cost-effective, and aligned with best practices in the industry. Required Qualifications: Bachelor's degree in computer science, engineering, or sciences with commensurate experience for Associate Director or Director level role, or equivalent demonstrated experience in a life science-related domain. Demonstrated experience and success in applications or systems design, engineering, and implementation in life sciences supporting Clinical applications, informatics, and software. Experience with digital product management and/or service delivery (e.g. SAFe, Scrum, ITSM). Strong knowledge of life science Clinical & CMC processes, including Regulatory Submissions (eCTD), Clinical Site Startup & Data Management. Demonstrated excellence in product management, project management and/or change management. Excellent communication skills, including the ability to communicate complex technical concepts to non-technical stakeholders. Knowledge of data management principles and practices. Experience with and understanding of: Cloud computing Networking Information Security Preferred Qualifications: Deep technical knowledge in technology domain areas (e.g. CDISC, IDMP). Demonstration of architecting Clinical informatics environments and integration to external (e.g. CRO) and 3rd party applications. Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. At Flagship, we recognize there is no perfect candidate. If you have some of the experience listed above but not all, please apply anyway. Experience comes in many forms, skills are transferable, and passion goes a long way. We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background. 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

Created: 2024-11-05