Director, Data Management Operations

Full Time On-Site/Hybrid Data Management Director Data Management Apply for this Job The Director of Data Management Operations is accountable for oversight and management of core Data Management operational activities, providing leadership for Data Management and/or cross-functional teams. This Data Management leader will establish and reinforce processes to optimize Data Management practices and drive execution of department strategy, including serving as a point of contact for IT. As part of the Data Management Leadership team, they will participate in the definition and execution of the Data Management operating strategy, ensuring continuous alignment between the strategy and operations by monitoring execution through reporting of metrics. Core accountabilities include leading efforts to modernize Data Management operations through operational improvements including the creation and execution of new processes and standards within Data Management. This leader will have oversight of vendor partnerships, ensure adherence of policies and procedures, and inspection readiness.

Key Responsibilities Include:

Strategy

• Develops Data and Reporting Standards infrastructure for Data Management in collaboration with key stakeholders.
• Defines and is accountable for the implementation and oversight of Data Management data collection standards.
• Contributes to the development of the strategy for outsourcing, budgeting, and vendor oversight, in collaboration with Development function heads.

Leadership

• Provides leadership and management of personnel in Data Management, cascading information and goals, and proposing operational strategy/improvements.
• Represents Data Management leadership on cross-functional teams as appropriate.
• Provides leadership in best practices for employee development through talent acquisition and retention; management; and development of departmental staff.

Execution

• Ensures excellence in quality execution of data management data standards deliverables in support of the Apellis portfolio. Provides reviews/assessments of the effectiveness of existing Data Management processes to identify gaps and areas for improvements.
• Executes and improves the Data Management operational model/outsourcing strategy and ensures successful strategic relationships with vendors. Conducts after-action reviews to identify areas for development to strengthen vendor partnerships and ensure success.
• Identifies standard sets of metrics and measurements to use as a mechanism for measuring and reporting Data Management progress, quality, and compliance.
• Supports financial oversight and optimization of the Data Management operational/functional budget.
• Oversees aspects of recruitment (resource estimation), training and development of the department, and ensuring that skills and abilities are in line with future direction and strategies for Data Management and Apellis programs.
• Identify competencies that need to be improved/enhanced within the Data Management group, including additional/new technologies.
• Ensures Data Management inspection readiness by conducting internal monitoring of processes to ensure compliance with Data Management SOPs.
• Oversees Data Management initiatives and is a key contributor to the Development Operations strategy.
• Provides operational management including risk mitigation, capacity planning, delivery of technology solutions, and cross-functional communication.

Innovation:

• Keeps abreast of industry standards/changes and developments in the field, adoption of new tools and technologies that align with department strategies. Represents Apellis on external organizations/teams where appropriate to influence the changing landscape.
• Identifies and drives data standards related innovation initiatives to enhance efficiencies within the data flow. Collaborates to identify innovative technical advances, elevating the value of data standards and data sharing.
• Evaluates data sharing processes and metrics for continuous improvement opportunities.

Education, Registration & Certification:

• Bachelor’s degree required, Masters or PhD in Biology / Chemistry, Life Sciences, Statistics, or Drug Development preferred

Experience:

• 12+ years relevant work experience in data management
• Significant experience working in Sponsor organizations required

Skills, Knowledge & Abilities:

• Deep understanding of drug development and biopharmaceutical industry required
• Extensive knowledge of standards, regulatory and drug submission requirements and current regulatory trends
• Strong management and leadership skills, and ability to effectively lead and collaborate with various business functions
• Proven ability to manage multiple, competing priorities independently
• Demonstrated leadership, problem solving, conflict resolution, and team building skills
• Able to adapt and change gears quickly with the capacity to make difficult decisions independently.
• Direct leadership of initiatives/effective change management of process or technical improvements that advance data management department standards or practices.
• Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more! Visit https://apellis.com/careers/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.