Director Clinical Data Management Lead - Nephrology

The Director Clinical Data Management Lead Nephrology is a group head position accountable for the performance and results of operational portfolio technologies and process for the Clinical Data Management (CDM) function of Biogens 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 Hubs 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 Youll 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 .
• Participates in higher level Biometrics department and other crossfunctional initiatives.
• Contributes to the development of functional longterm 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

• Bachelors 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 riskbased 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 fullservice 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 $194000 $267000. 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 Biogens LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical dental life long and shortterm disability insurances vacation endofyear shutdown and 401K participation and matching contributions.

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an EVerify Employer in the United States.