[Hiring] Associate Director, Clinical Data Management @Biogen

Role Description

Biogen’s West Coast Hub, based in South 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.

The Associate Director of Clinical Data Management is a versatile and collaborative team member, influencing across functions and leadership to achieve program, operational, and organizational objectives. You will be accountable for all Clinical Data Management deliverables across assigned studies and clinical programs, serving as both a strategic partner and operational leader. This role collaborates closely with study teams, Data Management leadership, Data Standards and Governance, and cross-functional stakeholders to define and execute robust data strategies, ensuring high-quality data flow, data integrity, and process adherence. Leveraging deep phase, therapeutic area, and operational expertise, you will oversee portfolio-level milestones, standards, dashboards, timelines, and resource planning, including input to the annual operating plan. The role supports regulatory submissions, drives continuous improvement across multiple programs, interprets internal and external business challenges, and leads or contributes to departmental initiatives and workstreams. You will also be responsible for developing talent by providing training, coaching, and mentoring, both through day-to-day leadership and formal people management assignments.

What You’ll Do

• Accountable for providing Data Management expertise to assigned studies and/or programs by overseeing data quality and Data Management performance.
• Ensures consistent implementation of data collection standards, data cleaning standards, and quality plans.
• Contribute to the strategic development of the Data Management department, including processes, technology, data standards, reporting, process improvement, and innovation.
• Support the implementation of related process and system enhancements.
• Responsible for the hiring, assignment, and development of staff within direct or indirect reporting lines.
• Provide effective coaching and mentoring to ensure consistently high levels of performance and productivity.
• Deliver ongoing feedback, coaching, and career development support, including engagement and retention activities, to maximize staff potential.
• Act as a point of escalation for Data Management activities by interfacing with cross-functional customers.
• Resolve complex issues through effective problem solving and appropriate escalation to senior management.
• Research and resolve complex issues by leveraging appropriate resources and ensuring clear, thorough communication to support departmental awareness.

Who You Are

You thrive in collaborative environments and are adept at influencing across functions and leadership. Your expertise in Clinical Data Management allows you to serve as a strategic partner and operational leader, ensuring high-quality data flow and integrity. You possess deep knowledge in phase, therapeutic area, and operational expertise, overseeing milestones and resource planning. You excel in developing talent, providing training, coaching, and mentoring through day-to-day leadership. Your ability to drive continuous improvement and interpret business challenges makes you a valuable asset to the team.

Qualifications

• Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
• 12+ years relevant work experience in the Pharmaceutical/Biotech industry, with a focus on Clinical Data Management.
• In-depth understanding of drug development and the biopharmaceutical industry.
• Subject matter expertise in Clinical Data Management process, quality management, and data standards development.
• Robust technical experience with electronic data capture platforms (Medidata Rave preferred) and use of data review tools (elluminate preferred).
• Strong project management skills to effectively lead and collaborate with various business functions.
• Demonstrated ability to establish effective processes and relationships with external stakeholders, including implementing process change.
• High attention to detail, including proven ability to manage competing complex priorities successfully.
• Experience supporting audits and inspections.
• Demonstrated ability to influence without authority.
• Excellent written and oral communication skills in English.

Benefits

• Medical, Dental, Vision, & Life insurances.
• Fitness & Wellness programs including a fitness reimbursement.
• Short- and Long-Term Disability insurance.
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31).
• Up to 12 company paid holidays + 3 paid days off for Personal Significance.
• 80 hours of sick time per calendar year.
• Paid Maternity and Parental Leave benefit.
• 401(k) program participation with company matched contributions.
• Employee stock purchase plan.
• Tuition reimbursement of up to $10,000 per calendar year.
• Employee Resource Groups participation.