Associate Director in Development Management
4 weeks ago
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.
Our company has a unique 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.
Job Summary:The Associate Director in Development Management will hold 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.
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.
- 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.
- Knowledge of data management principles and practices.
- Experience with and understanding of:
- Cloud computing
- Networking
- Information Security
- Deep technical knowledge in technology domain areas (e.g. li>
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