Associate Director, Clinical Data Management

Company Description

HI-Bio, Inc. is a Biogen company based in South San Francisco, California. As of July 2, 2024, we are part of Biogen’s global team, with a commitment to excellence and a pioneering spirit. As part of a mid-sized biotechnology company, we offer the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission: Caring Deeply, Achieving Excellence, Changing Lives.

Our team in San Francisco is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.

Job Description

About This Role

The Associate Director of Clinical Data Management is accountable for all Clinical Data Management deliverables defined in Clinical Development plans for their assigned therapeutic area(s) within the respective development unit. Recognized as a strategic and operational Clinical Data Management specialist by all functions across the respective therapeutic development unit. Partners with the Principal Clinical Data Lead, Sr. Principal Clinical Data Lead, Analytics & Data Sciences Data Standards & Governance, and key portfolio team members to develop and ensure execution of a robust and clear Data Strategy Plan.  Uses phase, therapeutic area, and operational expertise to monitor all program level milestones.  Provides oversight and insightful expertise to the development of the portfolio level data collection standards, data flow and integrity plans, data cleaning standards, and quality plans to ensure process adherence and consistent execution across the data flow/portfolio.  Accountable to update and manage portfolio/program level dashboards, portfolio/program level timelines, resource prioritization (including input for annual operating plan) and resource management of CDLs/CDMs within the respective development unit. Supports regulatory submission activities as needed. Consults with key program team members to drive improvement and solutions across multiple programs within a therapeutic area/development unit. Persuades managers and leaders to act and/or negotiates with external partners/vendors/customers in relation to therapeutic areas within the respective DU to meet program goals and objectives. Contributes to the development of CDM management processes and participates and/or leads in initiatives/workstreams. Provides line management to a group of direct reports including but not limited to at least one Senior Principal Clinical Data Lead unless deemed to have a niche expertise by CDM senior leaders. 

What You’ll Do

• Provides oversight and insightful expertise to programs within a portfolio/ therapeutic area, establishes and reviews metric reports for DU level, and ensures data collection/cleaning standards and quality plans are consistently implemented on all programs within the development unit.  
• When managing direct reports, responsible for the hiring, promotion, transfer and assignment of staff within the respective DU. All ADs (including niche experts) provide effective coaching and mentoring of clinical data management team members to ensure consistently high levels of performance and productivity in support of various clinical trial teams. Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff to maximize their potential.
• Point of Escalation for the RDPT for all activities related to Data Management.  Liaises directly with internal customers (CDM, Data Sciences & Operations functions, GCO, Biostatistics, Regulatory Affairs, Medical). Solves complex problems by appropriately managing or escalating issues to senior management
• Contributes to the strategy and development of CDM processes, technology, therapeutic area data standards, reporting, departmental process improvement and innovation.
• Supports the Implementation of process or system improvements for global implementation
• Focuses on continuous improvement, defining and implementing the changes required to create an industry-leading clinical data capability, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards.

Who You Are

You communicate difficult concepts and negotiate with others to adopt a different point of view.  You link with other parts of the function, to ensure achievement of customer, operational, project or service obj