Director, Clinical Data Management Lead - Nephrology

Company 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. 

Job Description

The Director, Clinical Data Management Lead – Nephrology is a group head position accountable for the performance and results of operational portfolio execution, technologies, and process for the Clinical Data Management (CDM) function of Biogen’s West Coast Hub. As a leader and manager of FTEs and/or FSP resources, this role is recognized as an expert for depth and breadth of experience within their job discipline. This position solves unique problems that have broad impact on the business and contributes to the development of the West Coast Hub’s business unit strategy. This position reports to the Head of Biometrics, Biogen West Coast Hub.

** This position can be located in either South San Francisco, CA, or Cambridge, MA. **

What You’ll Do

• Provides data management expertise and broad functional oversight for the nephrology clinical pipeline. 
• Ensures standards compliance from study startup through database lock are adhered, and that milestone timelines and quality expectations are achieved.
• Leads key CDM business initiatives and/or projects with notable risk and complexity and develops strategy for project execution.
• Participates in higher level Biometrics department and other cross-functional initiatives.
• Contributes to the development of functional long-term strategy and develops business plans to ensure alignment. 
• Executes business plans and contributes to the development of functional strategy. 
• Accountable for global implementation of process improvements in collaboration with senior development department leaders. 
• Communicates and collaborates effectively with Data Management and other stakeholders in the broader Biogen organization.
• Impacts the direction and resource allocation for programs and projects within their discipline and collaborates with peers to influences the other disciplines to ensure a highly effective team is assigned. 
• Defines financial funding of projects and technologies for senior leadership alignment/approval.
• Ensures regulatory inspection readiness activities for all CDM deliverables is compliant with organization and company policies.

Who You Are

You are a motivating and energetic leader, capable of bringing Clinical Data Management programs forward.  You are passionate about solving problems and contributing to business strategy and objectives that really make an impact.

Qualifications

Required Skills

• Bachelor’s degree is required.  Advanced degree in a scientific discipline is preferred.
• 14+ years’ work experience in clinical data management within the Pharmaceutical/Biotech industry is required, including database programming, medical coding, systems integrations, and target or risk-based forms of data review and monitoring.
• Robust experience with Medidata Rave and use of Data Review tools is required.
• Expertise in drug development is required.
• Strong project management skills, and ability to effectively lead and collaborate with various business functions is required.  Project Management certification is preferred.
• High attention to detail, including proven ability to manage multiple competing priorities, is required.
• Expertise in DM processes, quality management, & data standards development, and for managing data management activities across a TA/program, is required.
• Demonstrated ability to establish effective business processes and relationships with external stakeholders, including implementing process change, is required.
• Expertise in oversight of clinical data management outsourcing with full-service, global CROs and FSPs is required.
• Ability to communicate complex ideas, anticipate potential objections, and persuade others, often at more senior levels, is required.
• Ability to direct the resolution of highly complex problems; looking beyond existing methodologies and own discipline to define and resolve complex problems, is required.

Additional Information

The base compensation range for this role is $194,000 - $267,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insuran