Senior Director, Clinical Data Management

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
 
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

In this role, you will ensure the integrity and timely delivery of high-quality clinical data management across Kailera’s portfolio. You will oversee data management activities performed by Strategic Partners, CROs, and other third-party vendors, ensuring compliance with best practices and regulatory requirements. Your responsibilities will include reconciling and cleaning external vendor data, implementing data management best practices, and driving cross-functional data review processes. Additionally, you will manage data operations, optimize resource allocation, and serve as a subject matter expert for internal initiatives related to process improvement, training, and compliance. You will also build and maintain strong relationships with Functional Service Providers to enhance data management capabilities and support the company’s evolving needs.

Preferred location: Waltham, MA (onsite or hybrid 2-3 days per week).

Responsibilities:

• Establish and drive global data management strategy related to resourcing, technologies and processes to maximize efficiency, innovation and data quality.
• Establish data standards in accordance with latest regulatory and industry practices
• Lead the global data management function to provide data collection, management and integration expertise in support of global development projects.
• Accountable for meeting annual goals, objectives and deliverables for both internal and external Clinical Data Management (CDM) stakeholders.
• Develop, implement and oversee an operational data ownership strategy in support of the global portfolio.
• Liaise with various internal and external teams by forging/maintaining strong partnerships with key stakeholders, e.g., Clinical Development, Pharmacovigilance, IT, Clinical Operations, and external vendors and CROs for the design and implementation of data management activities needed for clinical studies across all phases of clinical drug development.
• Provide insight on latest technologies and changes in regulatory environments, enabling emerging priorities and efficient data management leadership for global development programs.
• Lead systematic professional development and provide strong support for direct reports and other members of the Clinical Data Management function.
• Build and maintain relationship with one or more Functional Service Providers, designed to provide staff augmentation and support build of new and/or improved data management capabilities.
• Lead development of Clinical Data Management metrics, represent CDM function in projects and initiatives related to the reporting and analytics capabilities.

Required Qualifications:

• 12+ years of data management and leadership experience.
• Senior leadership experience in Clinical Data Management or related field, leading a medium to large organization and influencing executive-level management and key stakeholders.
• Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
• Expert knowledge of clinical data management principles, regulations and best practices, as well as common software products and technologies used in drug development.
• Ability to develop and evaluate business cases and effectively manage budgets.
• Knowledge of FDA and ICH regulations and industry standards applicable to drug development systems.
• Knowledge of regulations and best practices related to data collection, electronic records and signatures and data privacy.
• Operational experience in pharmaceutical drug development with significant direct exposure to clinical development.
• Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
• Demonstrated success in solving complex business problems, strategic thinking, organizational design, leadin